A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
Data Collection
Urogenital Diseases+20
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: September 1, 2005
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation. Secondary * Compare time to disease progression in patients treated with these regimens. * Compare progression-free survival of patients treated with carboplatin vs docetaxel. OUTLINE: This is a randomized, open-label, multicenter, pilot study. Patients are stratified according to gene mutation (BRCA1 vs BRCA2), prior adjuvant taxane chemotherapy (yes vs no), liver or lung metastasis affecting the parenchyma (yes vs no), Jewish ancestry by parent or grandparent (yes vs no), and first-line treatment vs second-line treatment. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive carboplatin IV over 1 hour on day 1. * Arm 2: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 3 or 6 courses of treatment may crossover to the alternative treatment arm. If progression is present after 3 courses in the crossover arm, patients may receive further treatment at the discretion of their oncologist. Patients responding to and tolerating treatment well, may be given 2 further courses in accordance with local center policy, although this is not encouraged. Patients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or 21 days. After completion of study treatment, patients are followed periodically for survival. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.148 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
Soroka University Medical Center
Beersheba, IsraelNaharia Hospital
Nahariya, IsraelChaim Sheba Medical Center
Tel Litwinsky, Israel