Page 12 - Delaware Medical Journal - February 2017
P. 12
CANCER PROTOCOL
NCI PROTOCOL OF THE MONTH
ECOG EA1131: A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients with Residual Triple- Negative
Basal-Like Breast Cancer following Neoadjuvant Chemotherapy The objectives of the trial are:
Pimary Objective:
To compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to
postpreoperative platinum based chemotherapy with those who are randomized to capecitabine.
Secondary Objectives:
To evaluate OS and RFS in the two arms in patients with TNBC with residual basal-like disease after neoadjuvant chemotherapy.
To characterize the side effects and tolerability of each platinum agent (cisplatin and carboplatin) as well as capecitabine in patients with TNBC with residual disease after neoadjuvant chemotherapy.
To identify the rate of basal-like gene expression using PAM50 analysis by digital mRNA quantitation amongst drug-resistant residual TNBC after neoadjuvant chemotherapy.
To compare the IDFS in TNBC patients with residual non-basal-like disease after neoadjuvant chemotherapy who are randomized to postpreoperative platinum based chemotherapy with those who are randomized to capecitabine (exploratory analysis).
Eligibilty: This study involves screening and randomization. Tumor tissue specimen must be submitted for PAM50 analysis for
STEP 0:
or capecitabine as part of their neoadjuvant therapy regimen.
mastectomy or breast conserving surgery is acceptable. Sentinel node biopsy post neoadjuvant chemotherapy (i.e. at the time
Adequate bone marrow and organ function based on the laboratory values obtained within 8 weeks prior to screening for
protocol therapy.
STEP 1:
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of
contraception or to abstain from sexual intercourse during participation in the study. Women must not be pregnant or breast-
feed.
Patients must have completed adjuvant radiotherapy and treatment with any investigational agent.
Treatment:
Arm A Observation closed to accrual
Arm B:
OR
Arm C:
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
44
Del Med J | February 2017 |
Vol. 89 |
No. 2
