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

• Conditions: To determine whether there is evidence that carboplatin alone is an active and safe therapy in women with metastatic breast cancer who are BRCA1 or 2 mutation carriers.Determinar si hay evidencia que la administración única de carboplatino es una terapia activa y segura en mujeres con cáncer de mama metastásico portadoras de la mutación BRCA1 o 2.

• Registration Number: EUCTR2004-001496-20-ES
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-09
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•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

Exclusion Criteria

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified