Phase 2 Study of Atezolizumab and Sacituzumab Govitecan to Prevent Recurrence in Triple Negative Breast Cancer with Residual Disease and Circulating Tumor DNA

What this Trial Is About

Researchers are evaluating a combination of two investigational drugs, sacituzumab govitecan and atezolizumab, as a treatment for patients with triple negative breast cancer who have residual cancer in the breast or lymph nodes and circulating tumor DNA in their blood. This phase II trial aims to determine if these drugs work together to prevent cancer recurrence after prior treatments including chemotherapy and surgery. The study includes patients with HER2-negative, hormone receptor-negative breast cancer who have completed neoadjuvant chemotherapy and locoregional therapy. Participants will receive the combination therapy for 18 weeks, consisting of six cycles of treatment. Atezolizumab is given intravenously on day 1 of each 21-day cycle, while sacituzumab govitecan is given intravenously on days 1 and 8 of each cycle. After completing treatment, participants will be followed every six months for up to three years to monitor their health and cancer status. During the study, participants will undergo screening to confirm eligibility, laboratory tests, stool collection, and regular follow-up visits. Researchers will measure the rate at which circulating tumor DNA becomes undetectable after treatment cycles, as well as track treatment-related side effects and long-term outcomes such as disease-free survival and overall survival over three years. This comprehensive monitoring aims to assess both the immediate and lasting effects of the drug combination.

Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)