About this trial
This clinical research study will be testing the experimental treatment which is a combination of sacituzumab govitecan and pembrolizumab.The combination of sacituzumab govitecan and pembrolizumab has not been approved by any health authorities for the treatment of high-risk early TNBC that remains after pre-surgical treatment and surgery.
The purpose of this study is to see if sacituzumab govitecan in combination with 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.
This is a randomized, open-label study. Patients will be randomly assigned to receive either the experimental treatment, sacituzumab govitecan in combination with pembrolizumab, OR 1 of the following 2 treatment regimens chosen by the study doctor: • Pembrolizumab alone OR •Pembrolizumab in combination with capecitabine.
Patient Profile
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.
Where’s this trial being run?
Beaumont Hospital, Cork University Hospital, St James’s Hospital, University Hospital Galway, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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QuestionsSummary Data
| Name: | ASCENT-05 |
|---|---|
| Number: | 24-36 |
| 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 |
| Principal Investigator: | Prof Patrick Morris (Beaumont Hospital) |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Gilead Sciences |
| Recruitment Started: |
Global: Dec 2022 Ireland: Jan 2025 |
| Global Recruitment Target: | 1514 |
|---|---|
| Ireland Recruitment Target: | 25 |