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

Pfizer39 enrolled

Overview

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®

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Neoplasms

Interventions

AromasinOTHER

Non-Interventional study design.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Pfizer Investigational Site

Bangalore, Karnataka, India

Pfizer Investigational Site

Ludhiana, Punjab, India

Pfizer Investigational Site

Ludhiana, Punjab, India

Pfizer Investigational Site

Lucknow, Uttar Pradesh, India

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)

Number of Participants Who Died

Time frame: Baseline until death (up to Year 3.5)

Number of Participants Who Discontinued Aromasin Therapy

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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