Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321633
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-05-02
Brief Title:
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
Sponsor:
University College London Hospitals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer BRCA Trial
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BBC-CRUK-BRCA-TRIAL | None | None | None |
| CRUK-BRCA-TRIAL | None | None | None |
| EUDRACT-2004-001496-20 | None | None | None |
| EU-20603 | None | None | None |
| ISRCTN43372330 | None | None | None |