Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

Pfizer89 enrolled

Overview

Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.

This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Early Breast Cancer

Interventions

Aromasin (exemestane)OTHER

Aromasin (exemestane), tablets 25 mg, once a day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal females. * Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment. * Patients whose tumour was estrogen receptor positive (ER+). * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: * Patients for whom Aromasin® treatment is contraindicated (see SPC). * Presence of metastasis or a contra lateral tumour. * Other adjuvant endocrine therapy. * Another concomitant antineoplastic treatment. * Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.