Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Medroxyprogesterone acetate, aminoglutethimide, hydrocortisone
Primary outcome measure
Not provided at time of registration.
Secondary outcome measures
Not provided at time of registration.
Overall study start date
01/08/1991
Overall study end date
01/08/1996
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Advanced breast cancer
2. Relapsed or failed following tamoxifen treatment
3. Postmenopausal
Participant type(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Ciba-Geigy Pharmaceuticals (Switzerland)
Sponsor details
-
-
-
Switzerland
Sponsor type
Industry
Website
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|