Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05)

Location: Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

Purpose:

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Sponsor: Gilead Sciences

https://clinicaltrials.gov/ct2/show/NCT05633654

Eligibility:

• Must have residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery.
• Must have had surgical removal of all evident disease in the breast and/or lymph nodes and have 
• Must have received appropriate radiotherapy and have recovered prior to starting study treatment.
  Adequate organ function.
• Cannot have stage IV (metastatic) breast cancer or history of any prior invasive breast cancer.
• Cannot have evidence of recurrent disease following therapy and surgery.
• Cannot have known germline breast cancer gene (BRCA) mutations.
• Must not have had myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%
• Must not have active serious infections requiring anti-microbial therapy.

Time Commitment: 10 years or longer