An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Study Overview
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Brief Summary
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To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India. Efficacy of the treatment with Aromasin® Safety of the treatment with Aromasin®

Detailed Description
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NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. 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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An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: Aromasin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible. Exclusion Criteria: Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included. Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Observational<br> | Other: Aromasin<br>* Non-Interventional study design.<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 Locoregional/Distant Recurrence of Primary Breast Cancer | Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes. | Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) | 
| Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer |  | Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) | 
| Number of Participants Who Died |  | Baseline until death (up to Year 3.5) | 
| Number of Participants Who Discontinued Aromasin Therapy |  | Baseline until discontinuation (up to Year 3.5) | 
| Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache. | Baseline up to 28 days after last dose of study treatment | 
| Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42 |  | Baseline, Month 6, 12, 18, 24, 30, 36, 42 | 
| Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 |  | Baseline, Month 6, 12, 18, 24, 30, 36, 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin, Antineoplastic Hormonal Drugs, Aromasin