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

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®

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: Aromasin

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational	Other: Aromasin; Non-Interventional study design.; Other Names: exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer	Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.	Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer		Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
Number of Participants Who Died		Baseline until death (up to Year 3.5)
Number of Participants Who Discontinued Aromasin Therapy		Baseline until discontinuation (up to Year 3.5)
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)	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.	Baseline up to 28 days after last dose of study treatment
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		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		Baseline, Month 6, 12, 18, 24, 30, 36, 42

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: October 20, 2008
• First Submitted That Met QC Criteria: October 20, 2008
• First Posted (ESTIMATE): October 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 19, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Aromasin; An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin; Antineoplastic Hormonal Drugs
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: A5991088