A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physicians Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
Study of Sacituzumab Govitecan (TRODELVY) in Patients with Triple-Negative Breast Cancer (TNBC)
Sponsor: Gilead Sciences, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU1562
U.S. Govt. ID: NCT03081234
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to see if sacituzumab govitecan can improve lifespans of patients with advanced triple-negative breast cancer (TNBC) and their tumor does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced TNBC. Information on the side effects, treatment benefit, your quality of life, and other supporting data will also be collected in this study. This is a randomized open-label study which means the study treatment you take will be chosen by chance (like the flip of the coin) in one of two groups. You will have 1 out of 2 chances to receive sacituzumab govitecan and 1 out of 2 chances to receive a treatment of physician's choice.
Investigator
Meghna Trivedi, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Do you have a life expectancy of more than 3 months? Yes No
Are you pregnant or breastfeeding? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162