Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR3004
Study information
Scientific title
Comparison of second-line hormonal agents medroxyprogesterone acetate and aminoglutethimide in advanced breast cancer
Acronym
Study hypothesis
Not provided at time of registration.
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Patients are randomised to receive either:
1. Group A: Medroxyprogesterone acetate 250 mg four times daily until disease progression or failure of treatment.
2. Group B: Aminoglutethimide 250 mg twice daily plus hydrocortisone 20 mg twice daily until disease progression or failure of treatment. There is a crossover option on disease progression or failure of treatment.
Intervention type
Drug
Phase
Not Applicable
Drug names
Medroxyprogesterone acetate, aminoglutethimide, hydrocortisone
Primary outcome measures
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/08/1991
Overall trial end date
01/08/1996
Reason abandoned
Eligibility
Participant inclusion criteria
1. Advanced breast cancer
2. Relapsed or failed following tamoxifen treatment
3. Postmenopausal
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/1991
Recruitment end date
01/08/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Industry
Funder name
Ciba-Geigy Pharmaceuticals, Farmitalia Carlo Erba
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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