Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice 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)
  Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
• Active Comparator: Treatment of Physician's Choice (TPC)
  Participants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle Nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of a 28-day cycle Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle

Geprüfte Regime

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

Quelle: ClinicalTrials.gov