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COMPLETED Phase 3

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

NCT02574455 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

Conditions Studied

Interventions

  • DRUG Sacituzumab govitecan
  • DRUG Capecitabine
  • DRUG Gemcitabine
  • DRUG Eribulin
  • DRUG Vinorelbine

Study Locations (20)

California

  • UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200 — Alhambra
  • UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200 — Burbank
  • UCLA Jonsson Comprehensive Cancer Center — Laguna Hills
  • UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza — Los Angeles
  • UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320 — Pasadena
  • University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street — San Francisco
  • UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard — Santa Monica

Colorado

  • Rocky Mountain Cancer Centers, 1700 South Potomac Street — Aurora
  • University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court — Aurora
  • Rocky Mountain Cancer Centers, 4715 Arapahoe Ave — Boulder
  • Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400 — Colorado Springs
  • Rocky Mountain Cancer Centers, 1800 Williams St. — Denver
  • Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400 — Denver
  • Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450 — Englewood

Alabama

  • Southern Cancer Center, 29653 Anchor Cross Blvd — Daphne
  • Souther Cancer Center, 3719 Dauphin St., 5 Floor — Mobile
  • Southern Cancer Center, 3 Mobile Infirmary Circle — Mobile
  • Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level — Mobile

Arizona

  • Mayo Clinic Hospital — Phoenix
  • Mayo Clinic Hospital — Scottsdale

Trial Details

FieldValue
Enrollment Target 529 participants
Start Date 2017-11-07
Est. Completion 2020-12-08
Phase Phase 3

Sponsor

Gilead Sciences

190 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02574455

The ClinicalTrials.gov registry entry for NCT02574455 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Sacituzumab govitecan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02574455 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02574455 about?

NCT02574455 is a clinical study titled "Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)". The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-neg...

What is the current status of trial NCT02574455?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2017-11-07. Estimated completion is 2020-12-08.

What conditions does trial NCT02574455 study?

This clinical trial studies the following conditions: Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02574455?

The interventions under investigation include: Sacituzumab govitecan (DRUG), Capecitabine (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Vinorelbine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02574455?

This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02574455 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial