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Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary 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: NCT00003418
Recruitment Status : Unknown
Verified March 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 23, 2004
Last Update Posted : December 19, 2013
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight breast cancer by blocking the uptake of estrogen. It is not yet known whether exemestane is more effective than tamoxifen in treating breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women with primary breast cancer who have already received 2-3 years of tamoxifen following surgery.

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

Detailed Description:

OBJECTIVES: I. Compare, in terms of disease-free survival and overall survival, the sequential administration of exemestane with administration of further tamoxifen until 5 years of therapy is achieved in postmenopausal women with operable breast cancer who have already received 2-3 years of adjuvant tamoxifen. II. Compare the regimens in terms of the incidence of contralateral breast cancer and long term tolerability of the regimens in these patients. III. Determine the tolerability of each regimen in terms of endometrial status, bone metabolism, lipid profile, and coagulation profile in these patients. IV. Assess quality of life in these patients treated with these regimens.

OUTLINE: This is a randomized, double blind, multicenter study. Following 2-3 years of adjuvant treatment with tamoxifen, patients are randomized to receive either oral tamoxifen daily or oral exemestane daily for the remainder of the 5 year period in the absence of disease relapse or unacceptable toxicity. Quality of life is assessed at some centers. Patients are followed at least every 3 months for the first year of treatment, every 6 months for the next two years and then annually thereafter until year 10.

PROJECTED ACCRUAL: Approximately 4400 patients (2200 patients in each arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
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
Study Start Date : February 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

DISEASE CHARACTERISTICS: At diagnosis: Histologically confirmed unilateral adenocarcinoma of the breast that was considered operable Must have had adequate therapy for primary disease including chemotherapy/ovarian ablation if appropriate and local postoperative radiotherapy if the patient received conservative (breast preserving) surgery Must have remained disease-free after therapy for primary disease Must have been receiving tamoxifen for minimum of 2 years and maximum of 3 years 1 month with no more than 1 month break at any one time No inflammatory breast cancer, histologically positive supraclavicular nodes, or ulceration/infiltration or skin metastases No evidence of local relapse or distant metastasis (on chest x-ray, scintigraphic bone scanning and liver ultrasonography/CT scanning) at any time Hormone receptor status: Estrogen receptor positive or unknown

PATIENT CHARACTERISTICS: Age: Postmenopausal as defined below Sex: Female Menopausal status: Postmenopausal as defined by: 55 years of age and over, and amenorrhea for greater than 2 years OR Radiation menopause (at least 3 months previously) or surgical oophorectomy OR Natural amenorrhea for at least 1 year at breast cancer diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Hemoglobin normal Hepatic: SGOT no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No significant cardiac disorder Other: No significant skeletal or endocrine disorders No clinical evidence of severe osteoporosis and/or history of osteoporotic fracture No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix No psychiatric or addictive disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior or concurrent bisphosphonates allowed Adjuvant or neoadjuvant chemotherapy for primary disease allowed Endocrine therapy: At least 4 weeks since prior hormone replacement therapy (oral, topical, or vaginal) Prior low-dose progestins for relief of menopausal symptoms (up to 6 months duration) allowed No concurrent progestins No concurrent systemic corticosteroids for a prolonged period (i.e., greater than 2 weeks) No concurrent selective estrogen receptor modulators Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: Prior participation and completion of therapy on another clinical study of systemic therapy (e.g., comparison of chemotherapy schedules) allowed No concurrent warfarin Concurrent treatment for other diseases allowed only when clinically indicated

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): NCT00003418

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U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Centre Antoine Lacassagne
Nice, France, 06189
United Kingdom
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Sponsors and Collaborators
International Collaborative Cancer Group
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci Charing Cross Hospital
Study Chair: Robert Paridaens, MD, PhD University Hospital, Gasthuisberg
Study Chair: Moise Namer, MD, PhD Centre Antoine Lacassagne
Publications of Results:
Coombes RC, Paridaens R, Jassem J, et al.: First mature analysis of the Intergroup Exemestane Study. [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA527, 2006.

Layout table for additonal information Identifier: NCT00003418    
Other Study ID Numbers: CDR0000066434
First Posted: January 23, 2004    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: March 2008
Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage III breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Molecular Mechanisms of Pharmacological Action
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