Breakthrough Breast Cancer & Cancer Research UK Genetic Breast cancer Trial: A randomised phase II pilot trial of carboplatin compared to docetaxel for patients with metastatic genetic breast cancer. - BRCA trial
- Conditions
- metastatic breast cancer in women with BRCA1 or BRCA2 mutation
- Registration Number
- EUCTR2004-001496-20-SE
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 148
histologically confirmed measurable metastatic breast cancer in known BRCA1 or 2 mutation carriers where chemotherapy is the treatment of choice
Patients with stable treated breast metastases will be eligible provided informed consent can be given and that other sites of measurable disease are present
patients with bone metastases currently receiving bisphosphonates will be eligible providing other sites of measurable disease are present
WHO performance status0,1 or 2
Normal heamatology and biochemical indices
normal renal function
written informed consent and able to comply with treatment and willing to attend long term follow up
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
patients unfit for chemotherapy or those with neuropathy > grade 1 (sensory or motor)
known allergy to platinum or mannitol
previous treatment with a platinum chemotherapy drug
abnormal bilirubin ASAT/ALAT > 3 x UNL
patients with a life expectancy of less than 3 months
prevoius malignancies other than adequately treated in situ carcinoma of the cervix or basal or squamous cell carcinoma of the skin, unless ther has been a disease free survival > 10 yeras
patients with bone limited disease or siutable for wndocrine therapy alone
other serious uncontrolled medical condition
pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether chemotherapy with carboplatin is a safe and effective treatment for women with metastatic breast cancer who are BRCA1 or BRCA2 carriers. the response to treatment with carboplatin will be compared to the response to the current standard treatment, docetaxel.;Secondary Objective: To determine whether the treatment with carboplatin prolongs the time to progression of metastatic breast cancer in women who are BRCA1 or BRCA2 carriers.;Primary end point(s): response and toxicity<br>Response will be evaluated after 3 and 6 cykles of chemotherapy using RECIST criteria with appropriate clinical assessment and radiological investigations. Toxicity will be assessed throughout the treatment period using the NCI CTCAE v 3.0
- Secondary Outcome Measures
Name Time Method