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

Condition(s) targeted: Breast Neoplasms

Intervention: Aromasin (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Pfizer

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

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

Primary outcome:

Changes in lipid measurements (HDL-C, LDL-C, total cholesterol and triglycerides) and bone mineral density

The proportion of subjects experiencing the events Locoregional/distant recurrence, appearance of 2nd primary or contralateral breast cancer, and death

The incidence rate of Locoregional/distant recurrence, appearance of 2nd primary or contralateral breast cancer, and death (per annum)

Incidence rates per annum of adverse events, in particular the specific events of interest (gynaecological, cardiac, thromboembolic , musculoskeletal, and menopausal)

Proportion discontinuing and discontinuation rate (per annum) from Aromasin® therapy

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bangalore, Karnataka 560 029, India; Recruiting

Pfizer Investigational Site, Ludhiana, Punjab 141 009, India; Recruiting

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 001, India; Recruiting

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

Starting date: December 2008
Last updated: September 28, 2010