Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

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. Identifier: NCT00032136
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: exemestane Drug: tamoxifen citrate Procedure: adjuvant therapy Phase 3

Detailed Description:


  • 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  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2001
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Relapse-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Incidence of second breast cancer in contralateral breast
  3. Safety and long term tolerability
  4. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Any age
  • See Menopausal status


  • 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


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


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


  • Creatinine less than 1.5 times ULN


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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • Not specified


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


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

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 identifier (NCT number): NCT00032136

United Kingdom
City Hospital - Birmingham
Birmingham, England, United Kingdom, B18 7QH
Sponsors and Collaborators
Cancer Research Campaign Clinical Trials Centre
Study Chair: Daniel Rea, MD City Hospital Birmingham

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00032136     History of Changes
Other Study ID Numbers: CRC-TU-TEAM
CDR0000069260 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: March 2007

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

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