NCT04230109

Sacituzumab Govitecan In TNBC

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study involves an experimental study treatment. The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG) The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open. Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Eligible participants will receive Sacituzumab govitecan for up to 12 weeks. * This can be followed by standard chemotherapy at the discretion of the treating physician. * It is expected that about 50 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC. Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading. After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open.

Conditions

• Invasive Breast Cancer
• Triple Negative Breast Cancer
• ER-Negative Breast Cancer
• PR-Negative Breast Cancer
• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Sacituzumab Govitecan	Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
DRUG	Pembrolizumab	Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)

Timeline

• Start date: 2020-07-14
• Primary completion: 2028-10-01
• Completion: 2029-10-01
• First posted: 2020-01-18
• Last updated: 2025-10-14

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study