Study of Sacituzumab Govitecan and Pembrolizumab in triple negative breast cancer (TNBC)
Research type
Research Study
Full title
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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
IRAS ID
1012130
Contact name
Shawn Sun
Contact email
Sponsor organisation
Gilead Sciences Inc
Eudract number
2024-512279-10
Clinicaltrials.gov Identifier
Research summary
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. This study will test an experimental
drug named sacituzumab govitecan in combination with pembrolizumab or pembrolizumab with or without capecitabine for patients
with high-risk early triple negative breast cancer (TNBC) without mutations in the BRCA1 or BRCA2 gene. For this study high-risk
early TNBC is defined as any presence of TNBC that still remains in the breast or lymph node tissue after receiving treatment and
undergoing surgery. Pembrolizumab can improve outcomes and delay the return of disease in patients with high-risk early TNBC
when compared to pembrolizumab alone or pembrolizumab in combination with capecitabine. Sacituzumab govitecan is a type of
drug called an antibody-drug conjugate. Antibodies are proteins normally made by the immune system. The antibody attaches to a
certain type of protein called Trop-2 found on many cancers, including breast cancer, and is conjugated (attached) to an anti-cancer
drug.
Pembrolizumab is an antibody and a type of immunotherapy that blocks the activity of a protein known as PD-1. By blocking PD-1, it
helps the immune system to recognize and fight off cancer cells.
Capecitabine is a type of chemotherapy tablet that blocks the ability of cancer cells to make DNA which stops their ability to grow. It
is used in the treatment of certain types of cancers including breast cancer.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0344
Date of REC Opinion
30 Jun 2025
REC opinion
Further Information Favourable Opinion