Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN43372330

Enrollment

148

Registered

2004-06-22

Start date

2005-01-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic genetic breast cancer Cancer Breast cancer

Interventions

Patients will be randomized 2:1 in favour of carboplatin. Treatment one: Carboplatin equal to the Area Under the Curve (AUC) of 6 mg/mL per minute every three weeks for six cycles

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To estimate progression free survival.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026