Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial
| ISRCTN | ISRCTN43372330 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43372330 |
| ClinicalTrials.gov (NCT) | NCT00321633 |
| Clinical Trials Information System (CTIS) | 2004-001496-20 |
| Protocol serial number | N/A |
| Sponsor | University College London (UK) |
| Funders | Breakthrough Breast Cancer, Cancer Research UK (via CTAAC) |
- Submission date
- 10/05/2004
- Registration date
- 22/06/2004
- Last edited
- 14/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr James Mackay
Scientific
Scientific
North East Thames Clinical Genetics Service
Great Ormond Street Hospital & the Institute of Child Health
30 Guilford Street
London
WC1 1EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial |
| Study acronym | BRCA Trial |
| Study objectives | Women who carry mutations in BRCA1 and 2 genes have an increased risk of up to 85% of developing breast cancer. Despite recent improvements in detection and treatment of early breast cancer, 25% of women will relapse with metastatic disease. Breast cancers in BRCA1 and 2 carriers are more frequently of high grade than cancers of women in general. Recent laboratory data have suggested that these mutations are sensitive to platinum drugs. The purpose of this trial is to assess whether carboplatin alone is a safe and effective treatment of metastatic breast cancer in women who are BRCA1 and 2 carriers. This will be compared to standard treatment with docetaxel in terms of toxicity, response and time to progression. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Metastatic genetic breast cancer |
| Intervention | Patients will be randomized 2:1 in favour of carboplatin. Treatment one: Carboplatin equal to the Area Under the Curve (AUC) of 6 mg/mL per minute every three weeks for six cycles Treatment two: Docetaxel 100 mg/m^2 every three weeks for six cycles Computed Tomography (CT) scan after three cycles: If no progression -continue with next three cycles If progression cross over to other treatment |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Docetaxel, carboplatin |
| Primary outcome measure(s) |
To determine whether carboplatin is a safe and effective treatment for women with relapsed breast cancer, who are BRCA 1 or 2 carriers. |
| Key secondary outcome measure(s) |
To estimate progression free survival. |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 148 |
| Key inclusion criteria | 1. Histologically confirmed metastatic breast cancer in BRCA 1/2 mutation carriers 2. Chemotherapy clinically indicated 3. Normal haematology and renal function 4. Patient consent 5. World Health Organisation (WHO)grade zero to two |
| Key exclusion criteria | 1. Unfit for chemotherapy or neuropathy more than Grade one 2. Known allergy to/previous treatment with platinum compounds 3. Known sensitivity to taxanes 4. Abnormal serum bilirubin 5. Life expectancy less than three months 6. Previous malignancies, uncontrolled medical conditions or concurrent illness 7. Pregnant or lactating women |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
North East Thames Clinical Genetics Service
London
WC1 1EH
United Kingdom
WC1 1EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2019: Study was terminated in March 2012 due to low recruitment and merged with another trial (EudraCT 2006-004470-26).
15/04/2016: No publications found, verifying study status with principal investigator.
