Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

Conditions

• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sacituzumab Govitecan-hziy — DRUG
  Administered intravenously
• Eribulin — DRUG
  Administered intravenously per NCCN guidelines
• Capecitabine — DRUG
  Administered orally per NCCN guidelines
• Gemcitabine — DRUG
  Administered intravenously per NCCN guidelines
• Vinorelbine — DRUG
  Administered intravenously per NCCN guidelines

Study Details

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Key Dates

Start date

May 8, 2019

Status verified

Sep 2024

Primary completion

Oct 20, 2023

Completion

Oct 20, 2023

Study Design

Enrollment

543 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sacituzumab Govitecan-hziy
  Participants will receive sacituzumab govitecan-hziy 10 mg/kg via intravenous (IV) injection administered on Day 1 and Day 8 of a 21-day cycle.
• Active Comparator: Treatment of Physician's Choice (TPC)
  Participants will receive TPC determined prior to randomization from one of the following single-agent treatment: Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic) * Eribulin: 1.4 mg/m\^2 for North American sites, 1.23 mg/m\^2 for European sites) via IV on Days 1 and 8 of a 21-day cycle * Capecitabine: 1000-1250 mg/m\^2 orally twice daily for 2 weeks followed by a 1-week rest period given as a 21-day cycle * Gemcitabine: 800-1200 mg/m\^2 via IV on Days 1, 8, and 15 of each 28-day cycle or per institution * Vinorelbine: 25 mg/m\^2 via IV on Day 1 weekly cycle per institution

Primary Outcome Measure

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment [ Time Frame: Up to 42.8 months ]

Locations (55)

Find similar trials in Avondale, AZ

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