Clinical trial · Interventional
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| brca1 Mutation Carrier | — | UNRESOLVED | — |
| brca2 Mutation Carrier | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Breast/Ovarian Cancer (brca1, brca2) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response and toxicity
Secondary outcomes (1)
- measure
- Time to progression
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available