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

NCT ID: NCT00776659

Last Updated: 2013-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-09-30

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.

Conditions

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Breast Neoplasms

Keywords

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An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin Antineoplastic Hormonal Drugs Aromasin

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Aromasin

Intervention Type OTHER

Non-Interventional study design.

Interventions

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Aromasin

Non-Interventional study design.

Intervention Type OTHER

Other Intervention Names

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exemestane

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Ludhiana, Punjab, India

Site Status

Pfizer Investigational Site

Ludhiana, Punjab, India

Site Status

Pfizer Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Countries

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India

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991088&StudyName=An%20Observational%20Study%20Of%20Indian%20Breast%20Cancer%20Patients%20Receiving%0AAdjuvant%20Therapy%20With%20Aromasin%0A

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5991088

Identifier Type: -

Identifier Source: org_study_id