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

September 12, 2013 updated by: Pfizer

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®

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 029
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141 004
        • Pfizer Investigational Site
      • Ludhiana, Punjab, India, 141 009
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 001
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Other: Aromasin
Non-Interventional study design.
Other Names:
  • exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Time Frame: 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.
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)
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)
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)
Baseline until discontinuation (up to Year 3.5)
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
Time Frame: 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.
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
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
Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Baseline, Month 6, 12, 18, 24, 30, 36, 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (ESTIMATE)

October 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5991088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Aromasin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe