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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) North Central Cancer Treatment Group Cancer and Leukemia Group B Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00520975 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.
PURPOSE: This randomized phase III trial is studying first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: bevacizumab Drug: carboplatin Drug: paclitaxel Drug: placebo Drug: trastuzumab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control |
Official Title: | A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab for Patients With HER-2/NEU Over-Expressing Metastatic Breast Cancer |
Estimated Enrollment: | 489 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: placebo
Given IV
Drug: trastuzumab
Given IV
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Arm B: Experimental
Patients receive trastuzumab and paclitaxel with or without carboplatin as in arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: bevacizumab
Given IV
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: trastuzumab
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are stratified according to prior treatment with adjuvant trastuzumab (Herceptin®) (yes vs no), prior treatment with neoadjuvant or adjuvant taxane (yes vs no), disease-free interval (> 24 months vs ≤ 24 months), and planned treatment with carboplatin (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm A:
Arm B:
After completion of study treatment, patients are followed periodically for 10 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer that overexpresses HER-2/NEU
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent full-dose anticoagulants (e.g., warfarin) with PT/INR > 1.5 allowed provided the following criteria are met:
No concurrent drugs known to inhibit platelet function, including the following:
Study Chair: | Ingrid Mayer, MD | Vanderbilt-Ingram Cancer Center |
Investigator: | Carlos L. Arteaga, MD | Vanderbilt-Ingram Cancer Center |
Study Chair: | Edith A. Perez, MD | Mayo Clinic |
Study Chair: | Nancy Lin, MD | Dana-Farber Cancer Institute |
Study Chair: | Mohammad Jahanzeb, MD | University of Tennessee |
Study ID Numbers: | CDR0000561762, ECOG-E1105 |
Study First Received: | August 24, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00520975 |
Health Authority: | Unspecified |
stage IV breast cancer male breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms, Male Paclitaxel Trastuzumab Breast Neoplasms |
Carboplatin Bevacizumab Breast Diseases Recurrence |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic |