An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Neoplasms
Intervention: Aromasin (Other)
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: 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«
Official title: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Number of Participants Who Died
Number of Participants Who Discontinued Aromasin Therapy
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
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
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- Patients with early breast cancer receiving adjuvant therapy with Aromasin┬« will be
- 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
Locations and Contacts
Pfizer Investigational Site, Bangalore, Karnataka 560 029, India
Pfizer Investigational Site, Ludhiana, Punjab 141 004, India
Pfizer Investigational Site, Ludhiana, Punjab 141 009, India
Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 001, India
To obtain contact information for a study center near you, click here.
Starting date: December 2008
Last updated: September 12, 2013