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Monoclonal Antibodies

Sacituzumab Govitecan-hziy for Breast Cancer (TROPiCS-02 Trial)

Phase 3
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new medication called sacituzumab govitecan-hzi for patients with a specific type of advanced breast cancer. Sacituzumab govitecan is a new type of medication that has been approved for treating a specific kind of advanced breast cancer. The medication targets and kills cancer cells by delivering a toxic substance directly to them. The goal is to see if it works better and is safer than other treatments chosen by doctors.

Eligible Conditions
  • Metastatic Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sacituzumab Govitecan-hziyExperimental Treatment1 Intervention
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.
Group II: Treatment of Physician's Choice (TPC)Active Control4 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2021
Completed Phase 3
~580

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,129 Previous Clinical Trials
867,040 Total Patients Enrolled
16 Trials studying Breast Cancer
6,177 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
356 Previous Clinical Trials
191,079 Total Patients Enrolled
2 Trials studying Breast Cancer
765 Patients Enrolled for Breast Cancer

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03901339 — Phase 3
Breast Cancer Research Study Groups: Treatment of Physician's Choice (TPC), Sacituzumab Govitecan-hziy
Breast Cancer Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT03901339 — Phase 3
Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03901339 — Phase 3
~85 spots leftby Oct 2025
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