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OpenTrials
Completed

NCT Number: NCT01094184

A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bangor, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
  • Participant who in the Investigator's opinion requires combination therapy for their disease
  • Life expectancy of greater than or equal to (>/=)12 weeks

Exclusion criteria

  • Previous chemotherapy for metastatic breast cancer
  • Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
  • Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment

Treatment and study plan

Bevacizumab

Drug

Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.

Other names: Avastin

paclitaxel

Drug

Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.

docetaxel

Drug

Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.

Primary outcomes

  1. Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2

    Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  2. Change From Baseline in FACT-B Score at Cycle 3

    Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  3. Change From Baseline in FACT-B Score at Cycle 4

    Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  4. Change From Baseline in FACT-B Score at Cycle 5

    Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  5. Change From Baseline in FACT-B Score at Cycle 6

    Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  6. Change From Baseline in FACT-B Score at Cycle 7

    Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  7. Change From Baseline in FACT-B Score at Cycle 8

    Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  8. Change From Baseline in FACT-B Score At Cycle 9

    Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  9. Change From Baseline in FACT-B Score at Cycle 10

    Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  10. Change From Baseline in FACT-B Score at Cycle 11

    Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  11. Change From Baseline in FACT-B Score at Cycle 12

    Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  12. Change From Baseline in FACT-B Score at Cycle 13

    Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  13. Change From Baseline in FACT-B Score at Cycle 14

    Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  14. Change From Baseline in FACT-B Score at Cycle 15

    Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  15. Change From Baseline in FACT-B Score at Cycle 16

    Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  16. Change From Baseline in FACT-B Score at Cycle 17

    Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  17. Change From Baseline in FACT-B Score at Cycle 18

    Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  18. Change From Baseline in FACT-B Score at Cycle 20

    Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  19. Change From Baseline in FACT-B Score at Cycle 21

    Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  20. Change From Baseline in FACT-B Score at Cycle 22

    Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  21. Change From Baseline in FACT-B Score at Cycle 23

    Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  22. Change From Baseline in FACT-B Score at Cycle 24

    Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  23. Change From Baseline in FACT-B Score at Cycle 25

    Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  24. Change From Baseline in FACT-B Score at Cycle 26

    Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  25. Change From Baseline in FACT-B Score at Cycle 27

    Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  26. Change From Baseline in FACT-B Score at Cycle 28

    Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  27. Change From Baseline in FACT-B Score at Cycle 29

    Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  28. Change From Baseline in FACT-B Score at Cycle 30

    Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  29. Change From Baseline in FACT-B Score at Cycle 32

    Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  30. Change From Baseline in FACT-B Score at Cycle 36

    Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  31. Change From Baseline in FACT-B Score at Cycle 37

    Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  32. Change From Baseline in FACT-B Score at Cycle 39

    Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  33. Change From Baseline in FACT-B Score at Cycle 42

    Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  34. Change From Baseline in FACT-B Score at Cycle 44

    Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  35. Change From Baseline in FACT-B Score at Cycle 46

    Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  36. Change From Baseline in FACT-B Score at End of Study

    Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

    FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.

  37. Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2

    Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  38. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3

    Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  39. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4

    Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  40. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5

    Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  41. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6

    Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  42. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7

    Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  43. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8

    Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  44. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9

    Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  45. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10

    Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  46. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11

    Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  47. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12

    Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  48. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13

    Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  49. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14

    Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  50. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15

    Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  51. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16

    Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  52. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17

    Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  53. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18

    Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  54. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20

    Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  55. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21

    Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  56. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22

    Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  57. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23

    Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  58. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24

    Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  59. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25

    Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  60. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26

    Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  61. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27

    Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  62. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28

    Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  63. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29

    Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  64. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30

    Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  65. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32

    Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  66. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36

    Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  67. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37

    Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  68. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39

    Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  69. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40

    Time frame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  70. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42

    Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  71. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44

    Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  72. Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46

    Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  73. Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study

    Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

  74. Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2

    Time frame: Baseline, Cycle 2 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  75. Change From Baseline in EQ-5D-VAS Score at Cycle 3

    Time frame: Baseline, Cycle 3 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  76. Change From Baseline in EQ-5D-VAS Score at Cycle 4

    Time frame: Baseline, Cycle 4 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  77. Change From Baseline in EQ-5D-VAS Score at Cycle 5

    Time frame: Baseline, Cycle 5 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  78. Change From Baseline in EQ-5D-VAS Score at Cycle 6

    Time frame: Baseline, Cycle 6 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  79. Change From Baseline in EQ-5D-VAS Score at Cycle 7

    Time frame: Baseline, Cycle 7 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  80. Change From Baseline in EQ-5D-VAS Score at Cycle 8

    Time frame: Baseline, Cycle 8 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  81. Change From Baseline in EQ-5D-VAS Score at Cycle 9

    Time frame: Baseline, Cycle 9 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  82. Change From Baseline in EQ-5D-VAS Score at Cycle 10

    Time frame: Baseline, Cycle 10 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  83. Change From Baseline in EQ-5D-VAS Score at Cycle 11

    Time frame: Baseline, Cycle 11 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  84. Change From Baseline in EQ-5D-VAS Score at Cycle 12

    Time frame: Baseline, Cycle 12 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  85. Change From Baseline in EQ-5D-VAS Score at Cycle 13

    Time frame: Baseline, Cycle 13 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  86. Change From Baseline in EQ-5D-VAS Score at Cycle 14

    Time frame: Baseline, Cycle 14 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  87. Change From Baseline in EQ-5D-VAS Score at Cycle 15

    Time frame: Baseline, Cycle 15 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  88. Change From Baseline in EQ-5D-VAS Score at Cycle 16

    Time frame: Baseline, Cycle 16 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  89. Change From Baseline in EQ-5D-VAS Score at Cycle 17

    Time frame: Baseline, Cycle 17 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  90. Change From Baseline in EQ-5D-VAS Score at Cycle 18

    Time frame: Baseline, Cycle 18 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  91. Change From Baseline in EQ-5D-VAS Score at Cycle 20

    Time frame: Baseline, Cycle 20 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  92. Change From Baseline in EQ-5D-VAS Score at Cycle 21

    Time frame: Baseline, Cycle 21 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  93. Change From Baseline in EQ-5D-VAS Score at Cycle 22

    Time frame: Baseline, Cycle 22 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  94. Change From Baseline in EQ-5D-VAS Score at Cycle 23

    Time frame: Baseline, Cycle 23 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  95. Change From Baseline in EQ-5D-VAS Score at Cycle 24

    Time frame: Baseline, Cycle 24 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  96. Change From Baseline in EQ-5D-VAS Score at Cycle 25

    Time frame: Baseline, Cycle 25 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  97. Change From Baseline in EQ-5D-VAS Score at Cycle 26

    Time frame: Baseline, Cycle 26 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  98. Change From Baseline in EQ-5D-VAS Score at Cycle 27

    Time frame: Baseline, Cycle 27 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  99. Change From Baseline in EQ-5D-VAS Score at Cycle 28

    Time frame: Baseline, Cycle 28 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  100. Change From Baseline in EQ-5D-VAS Score at Cycle 29

    Time frame: Baseline, Cycle 29 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  101. Change From Baseline in EQ-5D-VAS Score at Cycle 30

    Time frame: Baseline, Cycle 30 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  102. Change From Baseline in EQ-5D-VAS Score at Cycle 32

    Time frame: Baseline, Cycle 32 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  103. Change From Baseline in EQ-5D-VAS Score at Cycle 36

    Time frame: Baseline, Cycle 36 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  104. Change From Baseline in EQ-5D-VAS Score at Cycle 37

    Time frame: Baseline, Cycle 37 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  105. Change From Baseline in EQ-5D-VAS Score at Cycle 39

    Time frame: Baseline, Cycle 39 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  106. Change From Baseline in EQ-5D-VAS Score at Cycle 40

    Time frame: Baseline, Cycle 40 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  107. Change From Baseline in EQ-5D-VAS Score at Cycle 42

    Time frame: Baseline, Cycle 42 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  108. Change From Baseline in EQ-5D-VAS Score at Cycle 44

    Time frame: Baseline, Cycle 44 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  109. Change From Baseline in EQ-5D-VAS Score at Cycle 46

    Time frame: Baseline, Cycle 46 (Cycle length=2 and 3 weeks)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  110. Change From Baseline in EQ-5D-VAS Score at End of Study

    Time frame: Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

    EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Secondary outcomes

  1. Percentage of Participants Who Died Due to Any Cause

    Time frame: Baseline up to death (overall approximately 5 years and 9 months)

  2. Overall Survival

    Time frame: Baseline up to death (overall approximately 5 years and 9 months)

    Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.

  3. Percentage of Participants With Disease Progression

    Time frame: Baseline up to disease progression (overall approximately 5 years and 9 months)

    Disease progression was defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

  4. Time to Disease Progression

    Time frame: Baseline up to disease progression (overall approximately 5 years and 9 months)

    Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

  5. Percentage of Participants By Karnofsky Performance Status Scale Scores

    Time frame: Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)

    Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer

Acronym: BATMAN

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2010
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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