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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 |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00433511 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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 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 breast cancer by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: bevacizumab Drug: cyclophosphamide Drug: paclitaxel Drug: pegylated liposomal doxorubicin hydrochloride Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control |
Official Title: | A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer |
Estimated Enrollment: | 4950 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.
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Drug: cyclophosphamide
Given IV
Drug: paclitaxel
Given IV
Drug: pegylated liposomal doxorubicin hydrochloride
Given IV
Drug: placebo
Given IV over 30-90 minutes
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Arm II: Experimental
Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
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Drug: bevacizumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: paclitaxel
Given IV
Drug: pegylated liposomal doxorubicin hydrochloride
Given IV
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Arm III: Experimental
Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II. Treatment repeats every 2 or 3 weeks for 4 courses. Patients then receive paclitaxel as in arm I and bevacizumab as in arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Patients then receive open-label bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses.
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Drug: bevacizumab
Given IV
Drug: cyclophosphamide
Given IV
Drug: paclitaxel
Given IV
Drug: pegylated liposomal doxorubicin hydrochloride
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, partially double-blind, placebo-controlled, partially open-label, multicenter study. Patients are stratified according to planned dose schedule of doxorubicin hydrochloride and cyclophosphamide (every 3 weeks vs every 2 weeks). Patients are further stratified according to estrogen receptor status (positive vs negative), lymph node involvement (node-negative vs 1-3 positive node[s] vs ≥ 4 positive nodes), and received/planned treatment (lumpectomy and whole breast radiation therapy vs lumpectomy and accelerated partial-breast radiation therapy [before or after chemotherapy] vs mastectomy with no planned radiation therapy vs mastectomy with planned radiation therapy). Patients are randomized to 1 of 3 treatment arms (20% of patients are randomized to Arm I, 40% to Arm II, and 40% to Arm III).
In all arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 15 years.
PROJECTED ACCRUAL: A total of 4,950 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Significant risk of distant recurrence based on ≥ 1 of the following criteria:
LN negative with ER+ tumor ≥ 1 cm but < 5 cm with a recurrence score ≥ 11
Has undergone definitive breast surgery within the past 29-84 days, including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy
Surgical margins must be histologically free of invasive breast cancer and ductal carcinoma in situ
Planned post-lumpectomy radiation therapy required, including any of the following:
PATIENT CHARACTERISTICS:
No clinically significant cardiovascular or cerebrovascular disease, including any of the following:
Uncontrolled arrhythmia
PRIOR CONCURRENT THERAPY:
More than 28 days since prior major surgery
No prior cytotoxic chemotherapy or hormonal therapy for study cancer
Concurrent full-dose anticoagulation allowed provided the following criteria are met:
Study Chair: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
Investigator: | Ramona Swaby, MD | Fox Chase Cancer Center |
Study Chair: | Donald W. Northfelt, MD, FACP | Mayo Clinic Scottsdale |
Investigator: | Chau T. Dang, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000528955, ECOG-E5103 |
Study First Received: | February 8, 2007 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00433511 |
Health Authority: | Unspecified |
male breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
Skin Diseases Breast Neoplasms, Male Paclitaxel Breast Neoplasms |
Bevacizumab Cyclophosphamide Doxorubicin Breast Diseases |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Antibiotics, Antineoplastic Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Myeloablative Agonists Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |