This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. The high risk occurs despite surgical excision of the primary tumor and axillary lymph nodes to eliminate residual disease.
A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
B. Both males and females ≥ eighteen years of age
C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer that has been confirmed histologically at one point during the course of the disease. TNBC is defined as ER/PR IHC positivity rate of <10% and Her2Neu-negative (Phase I only)
D. A life expectancy of at least 6 months. (Phase I only)
A. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.
B. Females who are pregnant or breastfeeding.
C. History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
D. Hepatitis B infection except for prior vaccination. (Phase I and Phase II only).
Parallel
Capecitabine
DrugCapecitabine 1000 mg BID
Sarilumab 150mg or 200 mg plus Capecitabine
Combination productSarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID
Sarilumab 150mg plus Capecitabine
Combination productDose escalation schedule of sarilumab. The starting dose for sarilumab is 150 mg SQ every 21 days, given 3 days prior to the first 4 of 8 cycles of capecitabine 1000 mg BID.
Phase I: Maximum Tolerated Dose (MTD)
Establish MTD of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer
Phase I: Dose-limiting toxicity (DLT)
Defined events that are possibly, probably, or definitely related to the study treatment:
Phase II:To determine the percent of patients with positive CTCs and DTCs (if available) becoming negative CTCs and DTCs (if available) after treatment
Bone marrow aspirates will be performed before treatment and at defined time points during treatment.
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University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
