Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
17/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BR3007

Study information

Scientific title

A randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with advanced breast cancer

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

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 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 names

Medroxyprogesterone acetate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

31/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

-
-
-

Sponsor information

Organisation

UK Co-ordinating Committee for Cancer Research (UKCCCR)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Not defined

Funder name

Not available

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes