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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00785291 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, and ixabepilone, 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. It is not yet known which treatment regimen is more effective in treating patients with breast cancer.
PURPOSE: This randomized phase III trial is studying different chemotherapy regimens with or without bevacizumab and their side effects and comparing how well they work in treating patients with stage IIIC or stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: bevacizumab Drug: ixabepilone Drug: paclitaxel Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A RANDOMIZED PHASE III TRIAL OF WEEKLY PACLITAXEL COMPARED TO WEEKLY NANOPARTICLE ALBUMIN BOUND NAB-PACLITAXEL OR IXABEPILONE WITH OR WITHOUT BEVACIZUMAB AS FIRST[95]-LINE THERAPY FOR LOCALLY RECURRENT OR METASTATIC BREAST CANCER |
| Estimated Enrollment: | 900 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: paclitaxel
Given IV
|
|
Experimental: Arm II
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients may also receive bevacizumab as in arm I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
|
|
Experimental: Arm III
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive bevacizumab as in arm I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
|
Biological: bevacizumab
Given IV
Drug: ixabepilone
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
No non-measurable lesions, including any of the following:
HER2/neu status must be known
No progressing or untreated CNS metastases or leptomeningeal disease
Hormone receptor status must be known
PATIENT CHARACTERISTICS:
Urine protein ≤ 1+ OR urine protein:creatinine ratio < 1
No history of clinically significant cardiovascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior major surgical procedure or open biopsy and fully recovered
At least 7 days since prior hormonal therapy
Concurrent full-dose anticoagulants allowed but patient must be on a stable dose of warfarin or low molecular weight heparin
Contacts and Locations
Show 582 Study Locations| Study Chair: | Hope S. Rugo, MD | University of California, San Francisco |
| Investigator: | Alan P. Lyss, MD | CCOP - Heartland Research Consortium |
| Investigator: | Alvaro Moreno Aspitia, MD | Mayo Clinic |
More Information
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00785291 History of Changes |
| Other Study ID Numbers: | CDR0000617539, CALGB-40502 |
| Study First Received: | November 4, 2008 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Unspecified |
|
male breast cancer recurrent breast cancer stage IIIC breast cancer stage IV breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Epothilones Bevacizumab Tubulin Modulators Antimitotic Agents Mitosis Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |