Page 12 - Delaware Medical Journal July 2015
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
ECOG E2112: A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with
Hormone Receptor-Positive Advanced Breast Cancer
The objectives of the trial are: Primary Endpoints:
To evaluate whether the addition of entinostat to endocrine therapy improves progression-free survival and/or overall survival in postmenopausal patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer who have previously progressed on a non-steroidal aromatase inhibitor.
Secondary Endpoints:
• To evaluate the safety and tolerability of entinostat in combination with exemestane, and to compare the
• To evaluate the objective response rate of exemestane in combination with entinostat or placebo.
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in peripheral blood mononuclear cells.
• To evaluate the time to treatment deterioration of exemestane + entinostat versus exemestane + placebo
arms.
• To evaluate the differences in overall health-related quality of life between the exemestane + entinostat
versus exemestane + placebo arms.
Exploratory Objectives:
• To collect archival tumor samples and germline DNA to explore other potential biomarkers of therapeutic
• To collect patient ratings of AEs using select PRO-CTCAE items to evaluate the psychometric properties of PRO-CTCAE items.
Eligibility:
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during treatment prior to study randomization, and from any site.
• Patients must have measurable or non-measurable Stage III/locally advanced or metastatic carcinoma of
the breast.
• Patients must not have known central nervous system metastasis or a history of CNS metastases.
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randomization.
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Treatment:
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For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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Del Med J | July 2015
| Vol. 87 |
No. 7
