Sacituzumab Govitecan In TNBC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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 criteria

Qualifiers

Female or male patients ≥ 18 years of age.

Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

Not a woman of childbearing potential (WOCBP) OR

Complete abstinence from intercourse of reproductive potential, or

Disqualifiers

Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.)

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.

History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEF assessment is not specifically required for this trial), significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: ---Known risk to prolong the QT interval or induce Torsade's de Pointes.; Uncorrected hypomagnesemia or hypokalemia; Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg. Higher blood pressure is permissible per discretion of treating physician; Bradycardia (heart rate <50 at rest), by ECG or pulse; On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >470 screening ECG

Trial design

Treatments tested in this trial

  • Sacituzumab Govitecan
  • Pembrolizumab

Treatment groups

239 Participants
are divided into 2 treatment groups

Sponsors and collaborators