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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:
ClinicalTrials.gov Identifier:
NCT00776659
First Posted: October 21, 2008
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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) ]
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00776659     History of Changes
Other Study ID Numbers: A5991088
First Submitted: October 20, 2008
First Posted: October 21, 2008
Results First Submitted: September 12, 2013
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013
Last Verified: September 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