Phase 2 Study of Neoadjuvant Sacituzumab Govitecan Alone or with Pembrolizumab in Patients With Localized Triple Negative Breast Cancer

What this Trial Is About

Researchers are evaluating sacituzumab govitecan for people with localized triple negative breast cancer TNBC in this Phase II clinical trial. The study aims to assess the safety and effectiveness of this investigational drug, alone or combined with pembrolizumab, in treating this specific type of breast cancer. This trial is part of an umbrella study exploring different treatment options for breast cancer patients, including future arms for hormone receptor positive and inflammatory breast cancers. Participants will receive sacituzumab govitecan through intravenous infusions on two days every 21-day cycle, for up to four cycles approximately 12 weeks. After completing the sacituzumab govitecan monotherapy cohort, a combination therapy cohort with pembrolizumab will open. Some participants may also receive standard chemotherapy afterward, based on their doctors decision. The study includes screening, treatment, evaluations, and follow-up visits. During the study, participants will undergo various assessments including biopsies, laboratory tests, and evaluations to monitor response and safety. Researchers will measure outcomes such as the pathological complete response rate at 12 weeks, disease-free survival, overall survival, quality of life, and treatment-related side effects. The total participant involvement may last up to 36 months for long-term monitoring of outcomes and safety.

Sacituzumab Govitecan In TNBC