← Back to Search

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

TROPiCS-02 Trial Summary

This trial is testing a new drug, sacituzumab govitecan-hzi, against the current best treatment option for people with HR+ HER2- negative MBC. They will compare how well the new drug works and how safe it is.

Eligible Conditions
  • Metastatic Breast Cancer

TROPiCS-02 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS)
Secondary outcome measures
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
+8 more

TROPiCS-02 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
2019
Completed Phase 3
~550

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
842,936 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,150 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main indication for Sacituzumab Govitecan-hziy?

"Sacituzumab Govitecan-hziy is not only useful for patients that have undergone adjuvant anthracycline-containing therapy, but also those suffering from conditions like soft tissue sarcoma (sts), colorectal carcinoma, and malignant neoplasms."

Answered by AI

Are people currently signing up for this experiment?

"This particular study is not recruiting patients at this time. However, the trial was active from May 8th, 2019 to November 3rd, 2022. If you are looking for other trials, there are 2380 breast cancer studies and 866 Sacituzumab Govitecan-hziy studies that are still actively enrolling patients."

Answered by AI

Where are the various sites of this clinical trial located?

"At the moment, this trial is being conducted at 58 different sites which are situated in cities such as Kansas City, Minneapolis and Miami. There are also another 58 clinics in other locations. If you enrol for this study, it would be best to choose a location near to reduce travelling time and costs."

Answered by AI

How many patients are being enrolled in this trial?

"This study is no longer looking for patients to enroll. The trial was originally posted on May 8th, 2019 and was most recently edited on November 3rd, 2020. There are 2380 other trials currently underway for breast cancer and 866 for Sacituzumab Govitecan-hziy if you're interested in finding a different study to participate in."

Answered by AI

What are the previous successes of Sacituzumab Govitecan-hziy in medical trials?

"866 active clinical trials involving Sacituzumab Govitecan-hziy are ongoing, with the majority of these being Phase 3 trials. Most of these studies take place in Guangzhou, Guangdong; however, there are 37598 locations conducting research on this medication."

Answered by AI

When was the FDA's most recent decision on Sacituzumab Govitecan-hziy?

"Given that this is a Phase 3 trial with both efficacy and safety data, our team has determined that the risk level for Sacituzumab Govitecan-hziy is a 3."

Answered by AI
Recent research and studies
~92 spots leftby Apr 2025