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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) North Central Cancer Treatment Group NCIC Clinical Trials Group National Surgical Adjuvant Breast and Bowel Project (NSABP) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028990 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known whether paclitaxel works better with or without bevacizumab in treating breast cancer.
PURPOSE: This randomized phase III trial is to see if paclitaxel works better with or without bevacizumab in treating patients who have locally recurrent or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: bevacizumab Drug: paclitaxel |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Randomized Phase III Tial Of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) As First-Line Therapy For Locally Recurrent or Metastatic Breast Cancer |
| Study Start Date: | December 2001 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to disease-free interval (no more than 24 months vs more than 24 months), number of metastatic sites (less than 3 vs 3 or more), treatment with prior adjuvant chemotherapy (yes vs no), and estrogen receptor status (positive vs negative vs unknown). Patients are randomized to one of two treatment arms.
Quality of life is assessed at baseline and on day 1 of weeks 17 and 33.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 316-650 patients (158-325 per treatment arm) will be accrued for this study within 31 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
No HER-2-overexpressing (3+) breast cancer unless previously treated with trastuzumab (Herceptin)
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36607 | |
| United States, Arizona | |
| CCOP - Mayo Clinic Scottsdale Oncology Program | |
| Scottsdale, Arizona, United States, 85259-5404 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| CCOP - Atlanta Regional | |
| Atlanta, Georgia, United States, 30342-1701 | |
| United States, Illinois | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| United States, Iowa | |
| CCOP - Cedar Rapids Oncology Project | |
| Cedar Rapids, Iowa, United States, 52403-1206 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309-1016 | |
| Siouxland Hematology-Oncology | |
| Sioux City, Iowa, United States, 51101-1733 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CentraCare Health Plaza | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| United States, Nebraska | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, North Dakota | |
| Altru Cancer Center | |
| Grand Forks, North Dakota, United States, 58201 | |
| CCOP - Merit Care Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| Medcenter One Health System | |
| Bismarck, North Dakota, United States, 58501-5505 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623-3456 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |
| CCOP - Geisinger Clinic and Medical Center | |
| Danville, Pennsylvania, United States, 17822-2001 | |
| United States, South Carolina | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| CCOP - Sioux Community Cancer Consortium | |
| Sioux Falls, South Dakota, United States, 57104 | |
| Rapid City Regional Hospital | |
| Rapid City, South Dakota, United States, 57709 | |
| United States, Wisconsin | |
| CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
| Green Bay, Wisconsin, United States, 54301 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Study Chair: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
| Investigator: | Robin Zon, MD | Elkhart General Hospital |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
| Study Chair: | Tamara N. Shenkier, MD | British Columbia Cancer Agency |
| Study Chair: | Melody A. Cobleigh, MD | Rush University Medical Center |
More Information
| Study ID Numbers: | CDR0000069156, ECOG-2100, NCCTG-E2100, CAN-NCIC-MAC3, NSABP-E2100 |
| Study First Received: | January 4, 2002 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00028990 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer male breast cancer |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Breast Neoplasms Bevacizumab Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Phytogenic Breast Diseases |