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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00776659
First received: October 20, 2008
Last updated: September 12, 2013
Last verified: September 2013
  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:


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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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
Genders 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, 141 009
Pfizer Investigational Site
Ludhiana, Punjab, India, 141 004
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:
No publications provided

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
Health Authority: India: Soumya Multi Specialty Hospital Ethics Committee

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
Neoplasms by Site
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014