A randomised phase II pilot trial of carboplatin compared to docetaxel for patients with metastatic genetic breast cancer.Ensayo piloto randomizado en fase II que compara carboplatino y docetaxel en pacientes con cáncer de mama genético metastásico. - BRCA Trial

niversity College London0 个研究点开始时间: 2008年7月9日最近更新: 2012年4月18日

试验速览

暂无简介。

•Histologically confirmed breast cancer with measurable confirmed metastatic disease in a known BRCA 1or 2 carrier, where chemotheraphy 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 Perfomance Status 0, 1 or 2 (see Appendix 4)
•Adequate haematology, biochemical indices (FBC, U & E´s)
•LFT´s = Normal bilirubin, AST and/or ALT < 3 x ULN if Alk Phos >5 x ULN (or an isolated elevation AST/ALT of < 5 x ULN)
•Adequate renal function (GFR > 30ml/min and normal urea and creatinine)
•Written informed consent and able to comply with treatment and follow-up
•Patients who have not received anthracycline based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first line metastatic treatment and enter the trial at confirmed progression (second line).
•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) no
•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 compounds or to mannitol
•Known sensitivity to taxanes
•Previous tratment with a platinum chemotherapy drug, unless treatment was for non breast cancer related disease more than 10 years ago.
•LFT´s = Abnormal bilirubin (> ULN), AST and/or ALT > 3 x ULN and Alk Phos > 5 x ULN (or an isolated elevation AST/ALT > 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 conditionsor 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 premenopausal 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 throughtout 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)

发起方

niversity College London