Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
About this trial
This is an interventional treatment trial for brca1 Mutation Carrier focused on measuring stage IV breast cancer, recurrent breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), BRCA1 mutation carrier, BRCA2 mutation carrier
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer BRCA1 or BRCA2 mutation carrier Metastatic disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Stable, treated brain metastases allowed provided other sites of measurable disease are present Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line) No bone-limited disease No disease suitable for endocrine therapy alone Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Sex: female WHO performance status 0-2 Life expectancy ≥ 3 months AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase > 5 times ULN) Glomerular filtration rate ≥ 30 mL/min Normal urea and creatinine Normal hematological and biochemical studies Normal bilirubin Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after completion of study treatment Negative pregnancy test No known allergy to platinum compounds or mannitol No known sensitivity to taxanes No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin No sensory or motor neuropathy > grade 1 No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance No contraindication to chemotherapy PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 12 months since prior taxane therapy No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago
Sites / Locations
- Royal Melbourne Hospital
- Soroka University Medical Center
- Naharia Hospital
- Chaim Sheba Medical Center
- Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
- Vall d'Hebron University Hospital
- Lund University Hospital
- Addenbrooke's Hospital
- Royal Devon and Exeter Hospital
- UCL Cancer Institute
- Cookridge Hospital
- Leeds Cancer Centre at St. James's University Hospital
- Guy's Hospital
- Royal Marsden - Surrey
- Christie Hospital
- Clatterbridge Centre for Oncology
- James Paget Hospital
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Norfolk and Norwich University Hospital
- Dorset Cancer Centre
- Portsmouth Oncology Centre at Saint Mary's Hospital
- Southampton General Hospital
- Torbay Hospital
- Edinburgh Cancer Centre at Western General Hospital
- Velindre Cancer Center at Velindre Hospital