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

Terminated

• Conditions: Breast Neoplasms
• Interventions: Other: Aromasin

• Registration Number: NCT00776659
• Lead Sponsor: Pfizer

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Study Start: 2008-12
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-09
• Results First Submitted: 2013-09-12
• Results First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Results First Posted: 2013-11-19
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

• Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Aromasin	-

Primary Outcome Measures

Name	Time	Method
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 With Locoregional/Distant Recurrence of Primary Breast Cancer	Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)	Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
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)	Baseline up to 28 days after last dose of study treatment	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.
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Lucknow, Uttar Pradesh, India