Page 11 - Delaware Medical Journal - November/December 2019

EA1131: A Randomized Phase III Post-Operative Trial of Platinum-Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
The objectives of the trial are:
Primary Objective:
To compare the IDFS in TNBC patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-operative platinum-based chemotherapy with those who are randomized to capecitabine.
Secondary Objective:
• 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.
Correlative Biomarker Objectives: Exploratory Tobacco Use Objectives
Eligibility Criteria for Screening and Molecular Profiling (STEP 0):
• Female and male patients must have histologically confirmed invasive breast cancer.
• Patients must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen.
• Must have completed definitive resection of primary tumor.
• Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer at the time of definitive surgery, in the breast, measuring ≥ 1 cm in diameter.
• Radiotherapy may be given before or after protocol treatment per standard-of-care guidelines. When radiotherapy is planned prior to treatment, patients may be registered and screened while receiving RT.
• Adequate bone marrow and organ function based on laboratory values.
• No TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.
• Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification.
Eligibility Criteria for Randomization (Step 1):
• Screened patients will remain on the study and be randomized if they meet the criteria. No specific timeframe between registration and randomization needs to be observed. Randomization occurs no more than 24 weeks from surgery date
• Must have PAM50 analysis by digital mRNA quantitation on the FFPE of the residual disease in the breast resected at the time of definitive surgery completed.
• Patients must have completed treatment with any investigational agent ≥ 30 days prior to randomization for protocol therapy, if applicable.
• 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 while they are on study.
• Radiotherapy may be given before or after protocol treatment. When radiotherapy is planned prior to treatment, patients must have completed adjuvant radiotherapy ≥ 2 weeks prior to randomization.
• Adequate bone marrow and organ function based on lab values, ECOG PS 0-1 within 2 weeks prior to randomization.
Treatment:
Arm A: Observation
Arm B: Cisplatin 75 mg/m2 Day 1 every Q3W x 4 cycles OR Carboplatin AUC 6 Day 1 Q3W x 4 cycles Arm C: Capecitabine 1000 mg/m2 twice daily D1-14 every Q3w x 6 cycles
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
CANCER CLINICAL TRIAL
Del Med J | November/December 2019 | Vol. 91 | No. 6 251