An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin - Full Text View

Purpose

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®

Condition	Intervention
Breast Neoplasms	Other: Aromasin


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Exemestane

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer [ Time Frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) ]
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer [ Time Frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) ]
Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ]
Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ]
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study treatment ]
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
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 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ]
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 [ Time Frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42 ]


Enrollment:	39
Study Start Date:	December 2008
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Observational	Other: Aromasin Non-Interventional study design. Other Name: exemestane

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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776659

Locations


India
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 029
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 004
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 009
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 001

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00776659 History of Changes
Other Study ID Numbers:	A5991088
Study First Received:	October 20, 2008
Results First Received:	September 12, 2013
Last Updated:	September 12, 2013

Keywords provided by Pfizer:


An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin Antineoplastic Hormonal Drugs Aromasin

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Exemestane Antineoplastic Agents Aromatase Inhibitors	Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 20, 2017