Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Studien-Informationen

Ein-/Ausschlusskriterien

Studien-Rationale

Studien-Arme

• Experimental: Sacituzumab Govitecan-hziy (SG) + Pembrolizumab
  Participants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
• Active Comparator: Pembrolizumab + Treatment of Physician's Choice (TPC)
  Participants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: - Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles - Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles

Geprüfte Regime

• Sacituzumab Govitecan-hziy (IMMU-132 / Trodelvy™ / GS-0132 / ):
  Administered intravenously
• Pembrolizumab (KEYTRUDA®):
  Administered intravenously
• Paclitaxel (Taxol®):
  Administered intravenously
• nab-Paclitaxel (Abraxane®):
  Administered intravenously
• Gemcitabine (Gemzar):
  Administered intravenously
• Carboplatin:
  Administered intravenously

Quelle: ClinicalTrials.gov