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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Sacituzumab Govitecan
DrugSacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
Pembrolizumab
DrugPembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete response(pCR) rate with sacituzumab govitecan
pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.
Secondary outcomes
Disease-Free Survival
Kaplan-Meier methods and descriptive statistics
Overall Survival
Kaplan-Meier methods and descriptive statistics
Change in Breast Conserving Surgery Rate (BCS) rate
RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
CTCAE v5.0
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Gilead Sciences
Collaborator