Download AROMASIN (exemestane tablets) ADJUVANT CLINICAL

AROMASIN® (exemestane tablets)
ADJUVANT CLINICAL TRIAL FACT SHEET
Phase III Study Protocol Overview
Trial design:
Phase III randomized, double-blind trial examining oral
administration of exemestane (AROMASIN) versus placebo
for 2 years in postmenopausal women who have completed 5
years of adjuvant tamoxifen therapy.
Number of patients:
3000 patients targeted for total enrollment from sites in North
America
Cooperative group:
National Surgical Adjuvant Breast and Bowel Project
(NSABP)
Protocol Chairman:
Terry Mamounas, MD
Medical Director
Aultman Cancer Center
Protocol Officer:
Roy Smith, MD
Director, Medical Affairs and Medical Oversight
NSABP Operations Center
• Exemestane (Aromasin) 25 mg/day
• Placebo
Treatment arms:
Phase III Clinical Trial Objectives
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Evaluate if exemestane (Aromasin) impacts disease-free survival
Evaluate if exemestane (Aromasin) impacts overall survival
To compare the effect of tamoxifen withdrawal on bone with or without exemestane
(Aromasin)
Importance of Trial
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Currently there are no approved treatment options for women who are disease-free after they
have completed 5 years of tamoxifen therapy
Studies indicate that tamoxifen therapy offers no additional benefits after 5 years
Women already treated for breast cancer may harbor small tumor cells even after several
years of tamoxifen therapy, which could spread to another part of the body and cause a
recurrence of cancer after tamoxifen therapy is completed.
Exemestane’s (Aromasin) unique mechanism of action selectively targets and irreversibly
inactivates the aromatase enzyme, which results in reduced supply of estrogen to cancerous
cells and prevents the cells from continuing to grow
Sequential treatment with exemestane (Aromasin) during or immediately following
tamoxifen therapy may continue to treat hormone-sensitive tumors
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Eligibility Requirements
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Woman whose primary tumor was hormone (ER and /or PgR) receptor-positive
Woman must be postmenopausal
Disease-free following 4.9-5.5 years (57-66 months) of tamoxifen therapy (20 mg/day),
completed no more than 180 days prior to enrollment
Resected axillary nodes histologically positive or negative for tumor
Have had a lumpectomy and axillary node dissection or modified radical mastectomy
For more information on this study, please visit the NSABP Web site at www.nsabp.pitt.edu or
contact the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800422-6237).
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