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A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00649090
First received: March 27, 2008
Last updated: September 25, 2008
Last verified: September 2008
History of Changes
  Purpose

The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.


Condition Intervention Phase
Breast Neoplasms
 Drug: exemestane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Open-Label Exemestane Adjuvant Safety Surveillance Program: Adjuvant Exemestane (Aromasin) Treatment Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer (IES Inclusion Criteria)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assess for serious adverse events [ Time Frame: Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety Surveillance Program [ Time Frame: Duration of trial ] [ Designated as safety issue: Yes ]

Enrollment: 1549
Study Start Date: March 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exemestane group Drug: exemestane
Exemestane 25 mg oral tablet once daily for a maximum of 3 years

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal patients
  • Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
  • Estrogen receptor positive breast cancer patients
  • Patients who remain free from disease following treatment with tamoxifen

Exclusion Criteria:

  • Patients taking other drugs for the adjuvant treatment of breast cancer
  • Patients taking hormone replacement therapy
  • Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649090

  Show 63 Study Locations
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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00649090     History of Changes
Other Study ID Numbers: A5991077
Study First Received: March 27, 2008
Last Updated: September 25, 2008
Health Authority: Belgium: Directorate General for Medicinal product FPS of Public Health, Food Chain Security and Env

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Estrogens
Tamoxifen
Exemestane
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013