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

NCT00776659

Last updated date
Study Location
Pfizer Investigational Site
Bangalore, Karnataka, 560 029, India
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
Brief Title An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Official Title An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
Condition Breast Neoplasms
Intervention Other: Aromasin
Non-Interventional study design.
Other Name: exemestane
Study Groups/Cohorts Observational
Intervention: Other: Aromasin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 20, 2013)
39
Original Estimated Enrollment
 (submitted: October 20, 2008)
100
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00776659
Other Study ID Numbers A5991088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2013