| Source of record | UK Trials |
| ISRCTN | ISRCTN55268387 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BR3007 |
| Public title | A randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with advanced breast cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Not available |
| Sponsor name | UK Co-ordinating Committee for Cancer Research (UKCCCR) |
| Sponsor details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Sponsor telephone | +44 (0) 20 7670 4723 |
| Sponsor fax | +44 (0) 20 7670 4818 |
| Sponsor email | register@ctu.mrc.ac.uk |
| Sponsor website | http://www.ctu.mrc.ac.uk/ukcccr/home.html |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55268387 |
| Date last extracted from ISRCTN register | 17/04/2008 |
