Sacituzumab Govitecan In TNBC

Inclusion Criteria:

• Female or male patients ≥ 18 years of age.

• Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

• Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would bedetermined per ASCO/CAP guidelines by institutional (local) assessment. Patientswith multi-focal and multicentric disease are eligible provided all histologicallyexamined lesions are ER-/PR-/HER2- (local assessment). The need to biopsy additionallesions is at the discretion of the treating physician. Patients with bilateralinvasive breast cancer are eligible provided all histologically examined lesions areER-/PR-/HER2- (local assessment).

• Primary tumor (at least one lesion) 1 cm or greater measured by radiologicalimaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, anyprimary tumor size is permissible. Absence of distant metastatic disease (AJCC TNMstage M0). Staging scans are not required and are per discretion of the treatingphysician.

• Pre- and postmenopausal women are eligible.

• ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)

• Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performedand is able to comply with protocol requirements, including research biopsy.

• Patient has adequate bone marrow and organ function as defined by the followinglaboratory values at screening:

• Absolute neutrophil count (ANC) ≥ 1,500 per mm3

• Platelets ≥ 100,000 per mm3

• Hemoglobin ≥9.0 g/dL

• INR ≤1.5

• Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN.

• Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndromedirect bilirubin ≤1.5 x ULN.

Exclusion Criteria:

• Inflammatory breast cancer, or locally recurrent breast cancer

• Participants currently receiving systemic therapy for any other malignancy or havingreceived systemic therapy for a malignancy in the preceding 3 years.

• Uncontrolled inter-current illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia,or psychiatric illness/social situations that would limit compliance withstudy requirements.

• Clinically significant, uncontrolled heart disease and/or cardiac reppolarizationabnormality including any of the following:

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

• History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEFassessment is not specifically required for this trial),significant/symptomatic bradycardia, Long QT syndrome, family history ofidiopathic 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.

• Bradycardia (heart rate <50 at rest), by ECG or pulse. On screening, inability todetermine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) orQTcF >470 screening ECG

• Pregnant or breast-feeding women are excluded from this study because the safety ofstudy medications is not established.

• Known HIV-positive participants on combination antiretroviral therapy areineligible.

• These participants are at increased risk of lethal infections when treated withmarrow-suppressive therapy. Separate HIV testing for this trial is not required.Similarly, separate Hepatitis B or C testing for this trial is not required, butpatients with known (or history) of hepatitis B positive, or hepatitis C positiveinfection will be excluded