A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
- Compare the safety and effectiveness of carboplatin vs docetaxel in women with
metastatic breast cancer and the BRCA1 or BRCA2 gene mutation.
- 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
Patients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Response and toxicity
Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP