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Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer (IES)

This study has been completed.
Sponsor:
Collaborator:
International Collaborative Cancer Group (ICCG)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00038467
First received: May 31, 2002
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

To compare the sequential administration of exemestane with administration of further tamoxifen until 5 years in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen, in terms of disease-free survival (DFS), overall survival (OS), incidence of contralateral breast cancer and long-term tolerability.


Condition Intervention Phase
Breast Neoplasms
 Drug: Tamoxifen
Drug: Exemestane
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Trial In Postmenopausal Women With Primary Breast Cancer Who Have Received Adjuvant Tamoxifen For 2-3 Years, Comparing Subsequent Adjuvant Exemestane Treatment With Further Tamoxifen

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
  • Incidence of second breast cancer (in contralateral breast) [ Time Frame: June 2003, February 2006, December 2009, February 2013 ] [ Designated as safety issue: No ]
  • Long term tolerability of the regimens [ Time Frame: February 2006 ] [ Designated as safety issue: Yes ]

Enrollment: 4738
Study Start Date: February 1998
Study Completion Date: March 2013
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B Drug: Tamoxifen
Tamoxifen 20 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.
Experimental: A Drug: Exemestane
Exemestane 25 mg/day tablets administered p.o. for a period ranging from 2.5 to 3 years.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • postmenopausal women with histologically or cytologically confirmed primary breast adenocarcinoma, receiving tamoxifen and have been treated with tamoxifen continuously for between 2 and 3 years and one month, and still free of disease

Exclusion Criteria:

  • unresectable breast cancer
  • ER negative primary tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038467

  Show 380 Study Locations
Sponsors and Collaborators
Pfizer
International Collaborative Cancer Group (ICCG)
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: Pfizer
ClinicalTrials.gov Identifier: NCT00038467     History of Changes
Other Study ID Numbers: 96-OEXE-031, A5991012
Study First Received: May 31, 2002
Last Updated: May 9, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013