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Breast Neoplasms

Breast Diseases

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Exemestane

Anastrozole

Antineoplastic Agents, Hormonal

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Hormone Antagonists

25mg/day per VO until progression disease, after this progression the patient could receive the another drug (comparator arm) ie Anastrozole by investigator decision

1mg/day per VO until progression disease, after this progression the patient could receive the another drug (experimental arm) ie Exemestane by investigator decision

Study Director

This is a pivotal phase II, multicenter, open-label trial, designed to compare the efficacy of exemestane versus anastrozole as a first line treatment for advanced breast cancer. One hundred postmenopausal patients, with metastatic, positive hormone receptor breast cancer will be enrolled in this trial.

The primary study endpoint is objective response rate. The study has been designed following Simon's test, with a p1-p0=0.15. p1 is the optimum level of activity of the experimental treatment (exemestane), and p0 is the minimum expected activity. In this study, p1 is 25% (25% of RR) and p0 is 10% (10% of RR). With an alpha error of 0.05 and a beta error of 0.1, Simon test establishes a first step of 21 patients per treatment arm. If at least 2 objective responses are observed in exemestane arm, recruitment will continue until 100 patients have been recruited. After this second recruitment phase, at least 7 objective responses must be observed to confirm the expected exemestane level of activity.

Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients

Phase II Randomized, Multicenter, Crossover Clinical Trial for Administration of Exemestane vs. Anastrozole as First Line Treatment for Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer

Time from last patient included to progression disease

Time from crossover (2nd line) to progression disease

Completed response (CR) plus Partial Response (PR) plus Stable Diasease (SD) lasting ≥6 months

Completed response (CR) plus Partial Response (PR) plus Stable Diasease

Time from randomization of last patient included until death whatever cause.

Time from crossover until death whatever cause.

Patients who will receive at least one dose of Exemestane or Anastrozole will be evaluated for safety and toxicity. Safety will be assess by recording all clinical adverse events at each patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients	NCT00128843	Breast Cancer	Exemestane Anastrozole	18 Years - 90 Years	Spanish Breast Cancer Research Group
Exemestane Versus Anastrozole as First Line Hormone Therapy in Postmenopausal Metastatic Breast Cancer Patients	NCT00128843	Breast Cancer	Exemestane Anastrozole	18 Years - 90 Years	Spanish Breast Cancer Research Group

Spots Global Cancer Trial Database for positive hormone receptor tumours