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)
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-), HER2 negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment. Patients with multi-focal and multicentric disease are eligible provided all histologically examined lesions are ER-/PR-/HER2- (local assessment). The need to biopsy additional lesions is at the discretion of the treating physician. Patients with bilateral invasive breast cancer are eligible provided all histologically examined lesions are ER-/PR-/HER2- (local assessment).
Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0). Staging scans are not required and are per discretion of the treating physician.
Inflammatory breast cancer, or locally recurrent breast cancer
Participants currently receiving systemic therapy for any other malignancy or having received systemic therapy for a malignancy in the preceding 3 years.
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.
Single group
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)
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.
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
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Massachusetts General Hospital
Lead sponsor
Gilead Sciences
Collaborator
