DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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)

Phase: N/A

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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«

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.

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.

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

Additional Information

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

Starting date: December 2008
Last updated: September 12, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015