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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00785291 |
RATIONALE: 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. 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. It is not yet known which treatment regimen is more effective in treating patients with recurrent or metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works when given together with paclitaxel, paclitaxel albumin-stabilized nanoparticle formulation, or ixabepilone in treating patients with locally recurrent, stage IIIB, or stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer Cancer-Related Problem/Condition |
Drug: bevacizumab Drug: ixabepilone Drug: paclitaxel Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound NAB-Paclitaxel or Ixabepilone Combined With Bevacizumab as First-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 |
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Arm I: Active Comparator
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and 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.
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Drug: bevacizumab
Given IV
Drug: paclitaxel
Given IV
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Arm II: Experimental
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 and 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.
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Drug: bevacizumab
Given IV
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IV
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Arm III: Experimental
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15 and 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.
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Drug: bevacizumab
Given IV
Drug: ixabepilone
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to taxane as adjuvant therapy (yes or no) and estrogen receptor (ER) or progesterone (PgR) status (ER- or PgR- positive vs both ER- and PgR- negative). Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires about peripheral neuropathy at baseline and before each course of therapy. They also complete questionnaires about sociodemographics, non-cancer comorbidities, social support, and post-trial therapy at baseline and periodically thereafter.
After completion of study therapy, patients are followed every 6 months for 2 years and then annually for up to 3 years.
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
Hormone receptor status must be known
No progressing or untreated CNS metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
No history of clinically significant cardiovascular disease including any of the following:
PRIOR CONCURRENT THERAPY:
At least 7 days since core biopsy or other minor surgical procedure
Concurrent full-dose anticoagulants allowed but patient must be on a stable dose of warfarin or low molecular weight heparin
Study Chair: | Hope S. Rugo, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Investigator: | Alan P. Lyss, MD | CCOP - Heartland Research Consortium |
Investigator: | Alvaro Moreno Aspitia, MD | Mayo Clinic |
Study ID Numbers: | CDR0000617539, CALGB-40502 |
Study First Received: | November 4, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00785291 |
Health Authority: | Unspecified |
chemotherapeutic agent toxicity neurotoxicity psychosocial effects/treatment long-term effects secondary to cancer therapy in adults |
male breast cancer recurrent breast cancer stage IIIB breast cancer stage IV breast cancer |
Skin Diseases Neurotoxicity Syndromes Breast Neoplasms, Male Paclitaxel Epothilones Neurotoxicity syndromes |
Neoplasm Metastasis Breast Neoplasms 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 |