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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

Phase 3
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

R. Charles Coombes, MD, MRCP, FRCP, PhD, FMedSci

Investigator Role:

Study Chair

Investigator Affiliation:

Charing Cross Hospital


United States: Federal Government

Study ID:




Start Date:

February 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage III breast cancer
  • Breast Neoplasms