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Neoadjuvant Treatment of Breast Cancer Using Aromatase Inhibitors
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Name of the Trial
Phase III Randomized Study of Neoadjuvant Therapy Comprising Exemestane Versus
Letrozole Versus Anastrozole in Postmenopausal Women With Estrogen Receptor
Positive Stage II or III Breast Cancer (ACOSOG-Z1031). See the protocol
summary.
Principal Investigators
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Dr. Matthew Ellis
Principal Investigator |
Dr. Matthew Ellis and Dr. John Olson, American College of Surgeons Oncology
Group; Dr. Laura Esserman, Cancer and Leukemia Group B.
Why This Trial Is Important
Women with breast cancer that grows in response to the hormone estrogen often
benefit from treatment with drugs known as aromatase inhibitors (AIs). AIs block
the ability of an enzyme in the body called aromatase to make estrogen.
Researchers want to compare AI therapy and chemotherapy as neoadjuvant (before
surgery) treatments for breast cancer, but first they need to determine which
AI(s) to use in such a comparison. Neoadjuvant therapy may shrink tumors enough
to allow a woman to undergo breast-sparing surgery instead of mastectomy.
In this trial, women with estrogen-responsive (i.e., estrogen receptor-positive)
breast cancer will be treated with one of three AIs exemestane (Aromasin), letrozole (Femara), or anastrozole (Arimidex) before surgery to determine which AI(s)
to use in a future trial that compares neoadjuvant AI therapy and neoadjuvant
chemotherapy. If major differences between the AIs cannot be found, more than
one AI may be used in the future trial.
"Our long-term aim is to establish AI therapy as a standard neoadjuvant
treatment option," said Dr. Ellis. "Another goal of this trial is
to help us define a patient population that is likely to benefit from neoadjuvant
AI treatment. Through genomic analysis we will determine the molecular basis
for differences in aromatase inhibitor response."
Who Can Join This Trial
Researchers seek to enroll 375 postmenopausal women with ER-positive stage
II or stage III breast cancer. See the list
of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States and elsewhere are recruiting patients for
this trial. See the list
of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER
(1-800-422-6237) for more information. The toll-free call is confidential.
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