Skip to main content
OpenTrials
Completed

NCT Number: NCT00320541

A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Completed

Looking for future studies?

Notify Me

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 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ponce, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
  • Must be able to measure the disease by specific medical parameters
  • May have received breast cancer treatment in the early stage of the disease
  • May be restricted in physically strenuous activity but able to carry out light work.
  • Must have adequate organ function as seen in blood test results.

Exclusion

Criteria:

  • Cancer that has spread to the brain.
  • Unstable heart problems
  • Unstable high blood pressure.
  • Breast cancer treatment after the disease has considered to spread to other areas or organs.
  • Unable to agree with the requirements of the study

Treatment and study plan

Gemcitabine

Drug

1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Other names: LY188011, Gemzar

paclitaxel

Drug

90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Other names: Taxol

Bevacizumab

Drug

10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Other names: Avastin

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)

    Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).

Secondary outcomes

  1. Progression-free Survival (PFS)

    Time frame: baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)

    PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.

  2. Overall Survival

    Time frame: baseline to death from any cause (up to 35 months)

    Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.

  3. Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  4. Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  5. Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  6. Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  7. Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  8. Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

  9. Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy

    Time frame: Baseline through 30 days post therapy follow-up (up to 35 months)

    The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Genentech, Inc.

Registry information

Official study title

A Randomized Phase II Trial of Paclitaxel and Bevacizumab Versus Gemcitabine, Paclitaxel, and Bevacizumab as First Line Treatment for Locally Advanced or Metastatic Breast Cancer

Important dates

Study start
2006
Primary completion
2009
Study completion
2012
First posted
May 3, 2006
Registry last updated
Jul 22, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.