Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial: A randomised phase II pilot trial of docetaxel compared to carboplatin for patients with metastatic genetic breast cancer. - BRCA Trial

• Conditions: Metastatic breast cancer in women with BRCA 1 or BRCA 2 mutation

• Registration Number: EUCTR2004-001496-20-DE
• Lead Sponsor: niversity College London, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-02
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

- Histologically confirmed breast cancer with measurably confirmed metastatic disease in a known BRCA 1 or 2 carrier, 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 (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 =30 ml/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) 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

- Known sensitivity to taxanes

- Previous treatment 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 of =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 =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
Main Objective: To assess whether chemotherapy with carboplatin is a safe and effective treatment for women with metastatic breast cancer who are BRCA 1 or BRCA 2 carriers. The response to treatment with carboplatin will be compared to the response to the current standard treatment docetaxel.;Secondary Objective: To document whether treatment with carboplatin alone increases the time to disease progression, to estimate progression free survival (PFS) <br>;Primary end point(s): Primary: Response and toxicity<br><br>Response will be evaluated after 3 and 6 cycles of chemotherapy using RECIST criteria, with appropriate clinical assessment and radiological investigations. There will be a response evaluation committee to independently assess response. Toxicity will be assessed throughout the treatment period using NCI CTCAE v. 3.0 12/12/03.