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

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ClinicalTrials.gov Identifier: NCT00776659
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : October 21, 2008
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:

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 or disease Intervention/treatment
Breast Neoplasms 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 Design
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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An Observational Study Of Indian Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Study Start Date : December 2008
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational Other: Aromasin
Non-Interventional study design.
Other Name: exemestane


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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) ]
  3. Number of Participants Who Died [ Time Frame: Baseline until death (up to Year 3.5) ]
  4. Number of Participants Who Discontinued Aromasin Therapy [ Time Frame: Baseline until discontinuation (up to Year 3.5) ]
  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.

  6. 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 ]
  7. 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 ]

Eligibility Criteria
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 21, 2008    Key Record Dates
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