Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
27/01/2015
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

BR3004

Study information

Scientific title

Comparison of second-line hormonal agents medroxyprogesterone acetate and aminoglutethimide in 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

Treatment

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 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 names

Medroxyprogesterone acetate, aminoglutethimide, hydrocortisone

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/08/1991

Overall trial end date

01/08/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Advanced breast cancer
2. Relapsed or failed following tamoxifen treatment
3. Postmenopausal

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/1991

Recruitment end date

01/08/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Ciba-Geigy Pharmaceuticals (Switzerland)

Sponsor details

-
-
-
Switzerland

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Ciba-Geigy Pharmaceuticals, Farmitalia Carlo Erba

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