A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1

Contact:

NCT Number:

Protocol:

AAAU1562

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

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.

Are you Eligible? (Inclusion Criteria)

  • Must be 18 years of age or older
  • Have life expectancy more than 3 months
  • Must not be pregnant or breastfeeding

Specialty Area(s)

Principal Investigator