A randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with advanced breast cancer
| ISRCTN | ISRCTN55268387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55268387 |
| Protocol serial number | BR3007 |
| Sponsor | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Funder | Not available |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 17/02/2015
- 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 | A randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with 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 one of four treatment groups: 1. Group A: Loading dose medroxyprogesterone acetate (MPA), 1 g every 6 h for eight doses, followed by low dose maintenance 500 mg MPA daily 2. Group B: Low dose maintenance, 500 mg MPA daily 3. Group C: Loading dose MPA, 1 g every 6 h for eight doses, followed by high dose maintenance, 1000 mg MPA daily 4. Group D: High dose maintenance, 1000 mg MPA daily |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medroxyprogesterone acetate |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Key inclusion criteria | 1. Histologically proven advanced or metastatic disease 2. Measurable or assessable disease 3. Previously treated with tamoxifen resulting in relapse or no response 4. No previous therapy with medroxyprogesterone acetate (MPA) or other progesterones 5. No anti-cancer therapy within the preceding 4 weeks, but patients who, having stopped prior therapy show evidence of disease progression during the 4th week interval between treatments may enter the trial forthwith 6. Able to tolerate 8 weeks hormonal therapy 7. No evidence of brain metastases 8. No pre-existing malignancy, except non-melanomatous skin cancer |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
-
-
-
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 |
