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
Introduction
The target population in this study consists of patients with early triple-negative breast cancer who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant chemotherapy with or without checkpoint inhibition therapy and surgery.
This is a prospective, international, multicenter, randomized, open-label, phase III parallel group study evaluating the potential incremental efficacy and safety of sacituzumab govitecan in the post-NACT setting in triple negative patients (ER and PR <10%, HER2- negative per ASCO/CAP) at high risk of recurrence.
A total of 1514 patients will be enrolled in the study.
MA-NON-NA-US-00097_Gilead Oncology CT Breast Brochure Booklet
News
We are still looking for patients for this study. You are welcome to make a referral to one of our trial sites. Our prospective medical professionals can view the nearest trial sites on the new Reesi platform.
Here you will find the link to the login area.
Details of the participating trial centers can be found (in English) Search for clinical trials - EMA; after accessing the website, go to “Locations and contact points”. Short protocol and patient documents can be found under “Trial documents”.
Details on the study and the inclusion and exclusion criteria can also be found at Clinicaltrials.gov.
The study is already recruiting in Germany, Spain and Ireland.
Design
Further information on the study:
A study of the German Breast Group (GBG) in cooperation with Gilead Sciences Inc. (sponsor) The following study groups are involved:
EUCT number: 2024-512279-10-00
Protocol code des Sponsors: GS-US-595-6184
The study on the sponsor's website:
Contact
Viktoria Tierbach
