An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
18 Years
75 Years
Female
Breast Neoplasms
Trial Information
An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Locoregional/distant recurrence of the primary breast cancer
Outcome Time Frame:
2-3 years
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
India: Soumya Multi Specialty Hospital Ethics Committee
Study ID:
A5991088
NCT ID:
NCT00776659
Start Date:
December 2008
Completion Date:
September 2012
Related Keywords:
- Breast Neoplasms
- An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin
- Antineoplastic Hormonal Drugs
- Aromasin
- Breast Neoplasms
- Neoplasms
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