A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

Study Overview
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Brief Summary
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The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.

Detailed Description
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This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.

Official Title
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A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy

Conditions
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Invasive Early Breast Cancer

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 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 SmPC). 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. The patients are not supposed to participate to any other trial during all the study period.
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 |
| --- | --- |
| Aromasin<br>All patients included in the study | Drug: Aromasin<br>* 25 mg daily continuously<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 Treatment-Emergent Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE). | Baseline up to 28 days after last dose | 
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug | An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane 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 28 days after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Missed Exemestane Doses |  | Week 25, 49, 73, 97, 121, 145 | 
| Number of Participants With Reasons for Discontinuing Exemestane Therapy |  | Baseline up to Year 3 | 
| Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy |  | Baseline up to Year 3 | 
| Percentage of Participants Who Discontinued the Exemestane Therapy |  | Baseline up to Year 3 | 
| Recurrence-free Survival (RFS) | Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence. | Baseline up to Year 3 | 
| Time to Disease Progression (TTP) | Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site. | Baseline up to Year 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prospective, non-comparative, NIS, 600, postmenopausal, hormone-receptor, positive, EBC, tamoxifen, current medical practice.