Comparison of second-line hormonal agents medroxyprogesterone acetate and aminoglutethimide in advanced breast cancer
| ISRCTN | ISRCTN44725655 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44725655 |
| Protocol serial number | BR3004 |
| Sponsor | Ciba-Geigy Pharmaceuticals (Switzerland) |
| Funder | Ciba-Geigy Pharmaceuticals, Farmitalia Carlo Erba |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 27/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
- -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of second-line hormonal agents medroxyprogesterone acetate and aminoglutethimide in advanced breast cancer |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Medroxyprogesterone acetate, aminoglutethimide, hydrocortisone |
| Primary outcome measure(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 01/08/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Advanced breast cancer 2. Relapsed or failed following tamoxifen treatment 3. Postmenopausal |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/1991 |
| Date of final enrolment | 01/08/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
