Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

August 1, 2013 updated by: Cancer Research Campaign Clinical Trials Centre

An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy and tolerability of adjuvant exemestane versus adjuvant tamoxifen in postmenopausal women with early breast cancer.
  • Compare the relapse-free survival and overall survival of patients treated with these drugs.
  • Compare the incidence of contralateral breast cancer in patients treated with these drugs.
  • Compare the safety and long-term tolerability of these drugs in these patients.
  • Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or more nodes positive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral tamoxifen once daily
  • Arm II: Patients receive oral exemestane once daily. Treatment in both arms continues for a minimum of 5 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at months 3 and 12 during study.

Patients are followed at least annually.

PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

4400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B18 7QH
        • City Hospital - Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed early adenocarcinoma of the breast

    • Completely excised by surgery with curative intent (R0)

      • Any N OR
      • Any primary tumor greater than 3 cm OR
      • Any primary tumor grade III and greater than 1 cm
    • M0
  • No positive supraclavicular nodes

  • Hormone receptor status:

    • Estrogen and/or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age:

  • Any age
  • See Menopausal status

Sex:

  • Female

Menopausal status:

  • Postmenopausal

    • Any age with bilateral oophorectomy or amenorrhea for at least 5 years OR

    • Age 50 or over:

      • Natural amenorrhea for at least 1 year OR
      • Chemotherapy-induced amenorrhea for at least 2 years OR
      • Radiation-induced amenorrhea (at least 3 months since prior radiotherapy) OR

    • Under age 50:

      • If amenorrheic for less than 5 years (any cause) or prior hysterectomy without bilateral surgical oophorectomy, follicle-stimulating hormone must be assayed to confirm postmenopausal status

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Platelet count greater than 100,000/mm3
  • WBC greater than 3,000/mm3

Hepatic:

  • SGOT or SGPT less than 2.5 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No uncontrolled cardiac disease
  • No unstable angina
  • No congestive heart failure or arrhythmia requiring medical therapy
  • No myocardial infarction within the past 3 months

Other:

  • No severe osteoporosis
  • No other malignancies within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
  • No other serious concurrent disease that would preclude study
  • No psychiatric disorders that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior neoadjuvant chemotherapy
  • No more than 10 weeks since completion of prior adjuvant chemotherapy

Endocrine therapy:

  • No prior adjuvant hormonal therapy for breast cancer
  • No prior neoadjuvant hormonal therapy (prior to surgery) for duration of more than 4 weeks
  • At least 4 weeks since prior hormone replacement therapy

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  • No more than 10 weeks since completion of curative surgery

Other:

  • No other concurrent investigational agents or participation in another clinical study (except adjuvant cytotoxic chemotherapy studies)
  • Concurrent bisphosphonates allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relapse-free survival

Secondary Outcome Measures

Outcome Measure
Overall survival
Quality of life
Incidence of second breast cancer in contralateral breast
Safety and long term tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research Campaign Clinical Trials Centre

Investigators

  • Study Chair: Daniel Rea, MD, City Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

March 8, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-TU-TEAM
  • CDR0000069260 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20149
  • ISRCTN75225940

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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