RecruitingPhase 2NCT04230109

Sacituzumab Govitecan In TNBC

A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)


Sponsor

Massachusetts General Hospital

Enrollment

260 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sacituzumab govitecan, an antibody-drug combination treatment, in patients with triple-negative breast cancer (TNBC) — a type of breast cancer that does not respond to hormone or HER2-targeted therapies — who have not yet received any treatment for their cancer. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with invasive breast cancer that tests negative for estrogen receptors, progesterone receptors, and HER2 (triple-negative breast cancer) - You have not yet received any treatment for your breast cancer - Your cancer has been confirmed by biopsy **You may NOT be eligible if...** - Your breast cancer tests positive for estrogen receptors, progesterone receptors, or HER2 - You have already received treatment for this breast cancer - You are pregnant - You have serious organ problems (heart, liver, kidneys) - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan

Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)

DRUGPembrolizumab

Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)


Locations(5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital - North Shore Cancer Center

Danvers, Massachusetts, United States

Massachusetts General Hospital at Newton-Wellesley Hospital

Newton, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04230109


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