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

ISRCTN ISRCTN44725655
DOI https://doi.org/10.1186/ISRCTN44725655
Secondary identifying numbers BR3004
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
27/01/2015
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 typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleComparison of second-line hormonal agents medroxyprogesterone acetate and aminoglutethimide in 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 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Medroxyprogesterone acetate, aminoglutethimide, hydrocortisone
Primary outcome measureNot provided at time of registration.
Secondary outcome measuresNot provided at time of registration.
Overall study start date01/08/1991
Completion date01/08/1996

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Advanced breast cancer
2. Relapsed or failed following tamoxifen treatment
3. Postmenopausal
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/1991
Date of final enrolment01/08/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Ciba-Geigy Pharmaceuticals (Switzerland)
Industry

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Switzerland

ROR logo "ROR" https://ror.org/02f9zrr09

Funders

Funder type

Industry

Ciba-Geigy Pharmaceuticals, Farmitalia Carlo Erba

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