Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

Study Overview
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Brief Summary
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This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

Detailed Description
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The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Official Title
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A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Aromasin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal females, defined as one from the next : Natural menopause ≥1 year, Surgical ovariectomy, Chemotherapy-induced amenorrhoea ≥ 2 years. Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. Patients who are disease-free after 2 to 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 SmPC). Metastatic breast cancer or a contra lateral tumour. Other concomitant adjuvant endocrine therapy. Other concomitant antineoplastic treatment. Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
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 |
| --- | --- |
| 1<br> | Drug: Aromasin<br>* Aromasin® one 25 mg tablet to be taken once daily<br>* Other names: 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) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to Month 36 | 

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. | Baseline up to Month 36 | 
| 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. | Baseline up to Month 36 | 
| Percentage of Participants Who Discontinued the Study Medication |  | Baseline up to Month 36 | 
| Number of Participants With Reasons for Discontinuation From Study Medication |  | Baseline up to Month 36 | 
| Time to Discontinuation |  | Baseline up to Month 36 | 
| Recurrence-free Survival | Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause. | Baseline up to Month 36 | 
| Overall Survival | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). | Baseline until death (up to Month 36) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen