Condition category
Cancer
Date applied
10/05/2004
Date assigned
22/06/2004
Last edited
15/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr James Mackay

ORCID ID

Contact details

North East Thames Clinical Genetics Service
Great Ormond Street Hospital & the Institute of Child Health
30 Guilford Street
London
WC1 1EH
United Kingdom

Additional identifiers

EudraCT number

2004-001496-20

ClinicalTrials.gov number

NCT00321633

Protocol/serial number

N/A

Study information

Scientific title

Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial

Acronym

BRCA Trial

Study hypothesis

Women who carry mutations in BRCA1 and 2 genes have an increased risk of up to 85% of developing breast cancer. Despite recent improvements in detection and treatment of early breast cancer, 25% of women will relapse with metastatic disease. Breast cancers in BRCA1 and 2 carriers are more frequently of high grade than cancers of women in general. Recent laboratory data have suggested that these mutations are sensitive to platinum drugs. The purpose of this trial is to assess whether carboplatin alone is a safe and effective treatment of metastatic breast cancer in women who are BRCA1 and 2 carriers. This will be compared to standard treatment with docetaxel in terms of toxicity, response and time to progression.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Metastatic genetic breast cancer

Intervention

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
Treatment two: Docetaxel 100 mg/m^2 every three weeks for six cycles

Computed Tomography (CT) scan after three cycles:
If no progression -continue with next three cycles
If progression –cross over to other treatment

Intervention type

Drug

Phase

Phase II

Drug names

Docetaxel, carboplatin

Primary outcome measures

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

To estimate progression free survival.

Overall trial start date

01/01/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

148

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North East Thames Clinical Genetics Service
London
WC1 1EH
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Breakthrough Breast Cancer

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Cancer Research UK (via CTAAC)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/04/2016: No publications found, verifying study status with principal investigator.