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Completed

NCT Number: NCT00773695

A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter [mg/m^2], 5-fluorouracil 600 mg/m^2, and cyclophosphamide 600 mg/m^2] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram [mg/kg] as intravenous [IV] infusion every 3 weeks up 24 weeks).

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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

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Norvegian Radium Hospital Montebello; Dept of Oncology, Oslo, Norway

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (>=) 2.5 centimeters (cm) in size
  • Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (</=) 2
  • Normal baseline cardiac function (Left Ventricular Ejection Fraction [LVEF])

Exclusion criteria

  • Stage IV (metastatic) disease
  • Previous treatment for localized breast cancer less than (<) 24 months from diagnosis of present breast cancer
  • Other previous or current cancer except for basal cell cancer or in situ cervical cancer
  • Current or recent use of aspirin (greater than [>] 325 milligrams per day)
  • Clinically significant cardiovascular disease

Treatment and study plan

Aromatase Inhibitor

Drug

Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.

Bevacizumab

Drug

Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.

Other names: Avastin

Epirubicine

Drug

Participants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.

5-fluorouracil (5FU)

Drug

Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.

Cyclophosphamide

Drug

Participants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.

paclitaxel

Drug

Participants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.

docetaxel

Drug

Participants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.

Primary outcomes

  1. Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Secondary outcomes

  1. Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  2. Percentage of Participants With Type of Surgery

    Time frame: At Surgery (Between Weeks 24 and 25)

    Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.

  3. Percentage of Participants With Axillary Lymph Node Dissection Performed

    Time frame: At Surgery (Between Weeks 24 and 25)

  4. Pathological Tumor Size, as Assessed by Histopathological Examination

    Time frame: At Surgery (Between Weeks 24 and 25)

  5. Percentage of Participants With Presence of Tumor Cells Close to Resection Margin

    Time frame: At Surgery (Between Weeks 24 and 25)

  6. Percentage of Participants With Tumor Deposit in Other Body Parts

    Time frame: At Surgery (Between Weeks 24 and 25)

  7. Tumor Free Resection Margin

    Time frame: At Surgery (Between Weeks 24 and 25)

  8. Pathological Tumor Size as Measure Using Caliper

    Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25

  9. Pathological Tumor Size as Measure Using MRI

    Time frame: Baseline, Weeks 12 and 25

  10. Pathological Tumor Size as Measure Using Mamography

    Time frame: Baseline, Weeks 12 and 25

  11. Pathological Breast Tumor Size as Measure Using Ultrasound

    Time frame: Baseline, Weeks 12 and 25

  12. Pathological Axilla Tumor Size as Measure Using Ultrasound

    Time frame: Baseline, Weeks 12 and 25

  13. Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25

  14. Percentage of Participants With Lymph Node Involvement

    Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25

  15. Percentage of Participants With Objective Tumor Response, as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: Weeks 12 and 25

  16. Percentage of Participants With New Lesions

    Time frame: Weeks 12 and 25

  17. Percentage of Participants With Molecular Changes in Protein Kinase Expression

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  18. Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA)

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  19. Percentage of Participants With Molecular Changes in Protein Expression

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  20. Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  21. Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Disseminated Tumor Cells in Bone Marrow

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

  22. Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood

    Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Norwegian Radium Hospital

Registry information

Official study title

A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers

Important dates

Study start
2008
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2008
Registry last updated
Jan 9, 2023

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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