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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00320541
First received: April 28, 2006
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: gemcitabine
Drug: paclitaxel
Drug: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: baseline to death from any cause (up to 35 months) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 187
Study Start Date: May 2006
Study Completion Date: August 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paclitaxel plus bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Drug: paclitaxel
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Name: Taxol
Drug: bevacizumab
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Name: Avastin
Experimental: paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Drug: gemcitabine
1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Names:
  • LY188011
  • Gemzar
Drug: paclitaxel
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Name: Taxol
Drug: bevacizumab
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Name: Avastin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320541

  Show 32 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Genentech, Inc.
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00320541     History of Changes
Other Study ID Numbers: 10663, B9E-US-S377
Study First Received: April 28, 2006
Results First Received: April 26, 2010
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Breast Cancer
Cancer of Breast
Cancer of the breast
Breast Neoplasms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014