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

niversity College London0 个研究点目标入组 148 人开始时间: 2008年3月11日最近更新: 2012年4月18日

适应症

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•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

发起方

niversity College London