Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
- Conditions
- brca1 Mutation Carrierbrca2 Mutation CarrierBreast CancerHereditary Breast/Ovarian Cancer (brca1, brca2)
- Registration Number
- NCT00321633
- Lead Sponsor
- University College London Hospitals
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 148
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response and toxicity
- Secondary Outcome Measures
Name Time Method Time to progression
Trial Locations
- Locations (25)
Naharia Hospital
🇮🇱Naharia, Israel
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
UCL Cancer Institute
🇬🇧Hampstead, London, England, United Kingdom
Cookridge Hospital
🇬🇧Leeds, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Royal Marsden - Surrey
🇬🇧London, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Lund University Hospital
🇸🇪Lund, Sweden
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
🇵🇹Lisbon, Portugal
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
James Paget Hospital
🇬🇧Norfolk, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom