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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients

Conditions
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Early Breast Cancer

Intervention / Treatment
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* Other: Aromasin (exemestane)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Group<br>Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy | Other: Aromasin (exemestane)<br>* Aromasin (exemestane), tablets 25 mg, once a day<br>* Other names: Aromasin, exemestane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 0 up to Month 36 or early withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Concomitant Morbidities | Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable. | Month 0 up to Month 36 or early withdrawal | 
| Number of Participants With Concomitant Medications | Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. | Month 0 up to Month 36 or early withdrawal | 
| Percentage of Participants Who Discontinued the Study Medication |  | Month 0 up to Month 36 or early withdrawal | 
| Number of Participants With Reasons for Discontinuation From Study Treatment |  | Month 0 up to Month 36 or early withdrawal | 
| Time to Discontinuation of Study Medication |  | Month 0 up to Month 36 or early withdrawal | 
| Percentage of Participants With Recurrent Disease | Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases). | Month 36 or early withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exemestane, Adjuvant Treatment In Postmenopausal Women, Estrogen Receptor Positive Early Breast Cancer, Tamoxifen