CompletedPhase 2ACTRN12610000796088

Phase II study of aromatase inhibitors in women with potentially hormone responsive recurrent/metastatic gynaecological neoplasms


Sponsor

University of Sydney

Enrollment

350 participants

Start Date

Jan 11, 2012

Study Type

Interventional

Conditions

Summary

There is compelling evidence to support a study of aromatase inhibitors in selected patients with potentially hormone sensitive recurrent or metastatic gynecological cancers. Hormonal therapy is an attractive option in patients with recurrent gynecological cancers where the objective of treatment is palliation and prolongation of survival rather than cure. Aromatase inhibitors are generally well tolerated and in contrast to chemotherapy can be administered for prolonged periods with relatively little cumulative toxicity. The degree of activity and response rates reported in previous studies has varied considerably. This variability almost certainly reflects the heterogeneous populations treated, which have included women with advanced chemotherapy and hormone resistant tumours and those with a poor performance status where response rates are generally low. There is a clear need to investigate the role of hormonal therapies, particularly AIs, in women with potentially hormone responsive recurrent gynaecological cancers. Studies are required to establish the response rates, clinical benefit and quality of life as well as to identify predictors of response.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether an aromatase inhibitor (a hormone-blocking drug) can slow the growth of certain hormone-sensitive gynecological cancers that have returned or spread. Post-menopausal women aged 18 and older with recurrent ovarian, endometrial, or other gynecological cancers that test positive for hormone receptors may be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Registered patients are prescribed a 1mg Anastrazole (Armidex) tablet daily (orally) until disease progression

Registered patients are prescribed a 1mg Anastrazole (Armidex) tablet daily (orally) until disease progression


Locations(3)

Newcastle, United Kingdom

New Zealand

UZ Leuven, Belgium

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ACTRN12610000796088