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
Secondary identifying numbers BR3007
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with advanced breast cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Medroxyprogesterone acetate
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1998
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1998
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • United Kingdom

Study participating centre

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Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Not defined

Not available

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan