Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00321633|
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2)||Drug: carboplatin Drug: docetaxel||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||September 2009|
U.S. FDA Resources
- Response and toxicity
- Time to progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321633
|Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Soroka University Medical Center|
|Beer-Sheva, Israel, 84101|
|Chaim Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA|
|Lisbon, Portugal, 1099-023 Codex|
|Vall d'Hebron University Hospital|
|Barcelona, Spain, 08035|
|Lund University Hospital|
|Lund, Sweden, SE-22185|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Royal Devon and Exeter Hospital|
|Exeter, England, United Kingdom, EX2 5DW|
|UCL Cancer Institute|
|Hampstead, London, England, United Kingdom, NW3 2QG|
|Leeds, England, United Kingdom, LS16 6QB|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|London, England, United Kingdom, SE1 9RT|
|Royal Marsden - Surrey|
|London, England, United Kingdom, SW3 6JJ|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|James Paget Hospital|
|Norfolk, England, United Kingdom, NR31 6LA|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Norfolk and Norwich University Hospital|
|Norwich, England, United Kingdom, NR4 7UY|
|Dorset Cancer Centre|
|Poole Dorset, England, United Kingdom, BH15 2JB|
|Portsmouth Oncology Centre at Saint Mary's Hospital|
|Portsmouth Hants, England, United Kingdom, PO3 6AD|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Torquay, England, United Kingdom, TQ2 7AA|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Velindre Cancer Center at Velindre Hospital|
|Cardiff, Wales, United Kingdom, CF14 2TL|
|Study Chair:||Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP||Guy's Hospital|