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NCT04468061 · ClinicalTrials.gov registry record · Phase 2

Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC

A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.

Recruiting
Registry status
Phase 2
Development phase
110
Enrollment target
15
Study locations

NCT04468061 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 110 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 15 study locations across 10 states.

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The verdict

NCT04468061, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.

RECRUITING
Registry status
Phase 2
Development phase
110 participants
Enrollment target
15
Study locations

Study Summary

This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: * Sacituzumab govitecan (Trodelvy™;IMMU-132) * Pembrolizumab (Keytruda®; MK-3475)

Conditions Studied

Breast Cancer Triple Negative Breast Cancer PD-L1 Negative

Interventions

  • DRUG Pembrolizumab
  • DRUG Sacituzumab Govitecan

Study Locations (15)

Massachusetts

  • Dana Farber Cancer Institute - Boston
  • DFCI @ Foxborough - Foxborough
  • DFCI @ Milford Regional Hospital - Milford
  • DF/BWCC in Clinical Affiliation with South Shore Hospital - South Weymouth

Florida

  • Miami Cancer Institute at Baptist Health (Kendall) - Miami
  • Miami Cancer Institute at Baptist Health - Plantation

Ohio

  • The Christ Hospital Cancer Center - Cincinnati
  • Ohio State University Medical Center - Columbus

Connecticut

  • Stamford Hospital - Stamford

Illinois

  • University of Chicago Medical Center - Chicago

Maine

  • Eastern Maine Medical Center - Brewer

North Carolina

  • The University of North Carolina at Chapel Hill - Chapel Hill

Pennsylvania

  • University of Pennsylvania-Abramson Cancer Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2020-07-20
Est. Completion 2029-04-01
Phase Phase 2

Sponsor

Dana-Farber Cancer Institute

781 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04468061

The ClinicalTrials.gov registry entry for NCT04468061 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04468061 reports 15 study locations spanning 10 distinct geographic areas - top geographies include Massachusetts, Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT04468061 about?

NCT04468061 is a clinical study titled "Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC". This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: *...

What is the current status of trial NCT04468061?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2020-07-20. Estimated completion is 2029-04-01.

What conditions does trial NCT04468061 study?

This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, PD-L1 Negative.

What interventions are being tested in trial NCT04468061?

The interventions under investigation include: Pembrolizumab (DRUG), Sacituzumab Govitecan (DRUG).

Who is sponsoring clinical trial NCT04468061?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04468061 being conducted?

This trial has 15 study locations across Connecticut, Florida, Illinois, Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.