Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial

Phase 2

Completed

• Conditions: Metastatic genetic breast cancer; Cancer; Breast cancer

• Registration Number: ISRCTN43372330
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-06-22
• Study Completion: 2008-12-31
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

1. Histologically confirmed metastatic breast cancer in BRCA 1/2 mutation carriers
2. Chemotherapy clinically indicated
3. Normal haematology and renal function
4. Patient consent
5. World Health Organisation (WHO)grade zero to two

Exclusion Criteria

1. Unfit for chemotherapy or neuropathy more than Grade one
2. Known allergy to/previous treatment with platinum compounds
3. Known sensitivity to taxanes
4. Abnormal serum bilirubin
5. Life expectancy less than three months
6. Previous malignancies, uncontrolled medical conditions or concurrent illness
7. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether carboplatin is a safe and effective treatment for women with relapsed breast cancer, who are BRCA 1 or 2 carriers.

Secondary Outcome Measures

Name	Time	Method
To estimate progression free survival.