Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Must have clinical evidence of stage IV (M1) disease HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown At least 1 measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Patients with bone-only disease are not eligible Ineligible if currently experiencing a complete or partial response to prior hormonal therapy Patients with disease progression after prior response to hormonal therapy are eligible Disease progression without prior hormonal therapy is allowed Stable or asymptomatic brain metastasis allowed if: Other measurable disease exists Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Pre- or post-menopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Corrected calcium less than 12 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No documented myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Other: No active serious infection No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K No clinically significant (greater than grade 1) peripheral neuropathy No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation More than 6 months since prior adjuvant monoclonal antibody therapy More than 6 months since prior adjuvant vaccine therapy No prior trastuzumab (Herceptin) No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for metastatic breast cancer More than 6 months since prior adjuvant high-dose chemotherapy More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy Prior adjuvant taxanes allowed only if administered every 3 weeks Endocrine therapy: See Disease Characteristics Any number of prior hormonal therapies for metastatic breast cancer allowed Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy No concurrent anticancer hormonal agents (including megestrol) Radiotherapy: At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation) No prior radiotherapy to 30% or more of bone marrow No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease Surgery: At least 3 weeks since prior major surgery Other: More than 6 months since prior neoadjuvant therapy No other concurrent anticancer drugs
Sites / Locations
- Highlands Oncology Group
- Monterey Bay Oncology
- Wilshire Oncology Medical Group, Inc.
- University of California Davis Cancer Center
- New Britain General Hospital
- Center for Hematology and Oncology
- Cancer Research Network, Inc.
- Mayo Clinic
- MacNeal Cancer Center
- Oncology Specialists, SC
- Maine Center for Cancer Medicine and Blood Disorders
- Maryland Hematology/Oncology Associates
- St. John's Mercy Medical Center
- St. Barnabas Medical Center
- Finger Lakes Community Cancer Center
- Clinical Hematology & Oncology Service, Inc.
- Scranton Hematology-Oncology
- East Tennessee Oncology/Hematology, P.C.
- West Clinic
- Texas Cancer Care
- Oncology Consultants
- Scott and White Clinic
- Northern Virginia Oncology Group, P.C.
- Seattle Cancer Care Alliance
- Dean Medical Center