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

Last updated on October 11, 2019

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

NCT00776659
Pfizer
Terminated
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

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Descriptive Information
Brief TitleAn Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Official TitleAn 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 DescriptionNA 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 TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
ConditionBreast Neoplasms
InterventionOther: Aromasin
Non-Interventional study design.
Other Name: exemestane
Study Groups/CohortsObservational
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 StatusTerminated
Actual Enrollment
 (submitted: May 20, 2013)
39
Original Estimated Enrollment
 (submitted: October 20, 2008)
100
Actual Study Completion DateSeptember 2012
Actual Primary Completion DateSeptember 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
Ages18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00776659
Other Study ID NumbersA5991088
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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