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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 148

Inclusion Criteria

·Histologically confirmed measurable metastatic breast cancer in known BRCA1 or 2 mutation carriers, where chemotherapy is the treatment of choice
·Patients with stable, treated brain metastases will be eligible providing informed consent can be given and that other sites of measurable disease are present
·Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible providing other sites of measurable disease are present
·WHO Performance Status 0, 1 or 2
·Normal haematology, biochemical indices (FBC, U & E’s)
·LFT’s = Normal bilirubin, AST and/or ALT or=1.5 x ULN)
·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

Exclusion Criteria

·Patients unfit for chemotherapy or those with neuropathy >grade 1 (sensory or motor)
·Known allergy to platinum compounds or to mannitol
·Previous treatment with a platinum chemotherapy drug
·LFT’s = Abnormal bilirubin (> ULN), AST and/or ALT >3 x ULN and Alk Phos >5 x ULN (n.b. Alk Phos >2.5 x ULN if AST and/or ALT >1.5 x ULN)
·Patients with a life expectancy of less than 3 months
·Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease free interval of at least 10 years
·Patients with bone limited disease or suitable for endocrine therapy alone
·Other serious uncontrolled medical conditions or concurrent medical illness likely to compromise life expectancy and/or the completion of trial therapy
·Pregnant, lactating or potentially childbearing women not using adequate contraception (documentation of a negative serum HCG pregnancy test should be available for pre-menopausal women with intact reproductive organs, or women less than two years after the menopause. Fertile women and their partners must use a medically acceptable contraceptive throughout the treatment period and for six months following cessation of treatment. Subjects must be made aware before entering the trial of the risk in becoming pregnant).
n.b. Prior exposure to taxanes does not exclude patients providing that there is >or=12 months between previous exposure and trial entry.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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