Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, 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 whether carboplatin is more effective than docetaxel in treating patients with metastatic genetic breast cancer.

PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works compared to docetaxel in treating women with metastatic genetic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College London Hospitals
• Treatments: Carboplatin; Docetaxel

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