Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy. A breast MRI will be performed after treatment completion. Patients with complete clinical response will proceed to surgery. Patients with clinical residual disease will complete neoadjuvant rescue with 4 cycles of doxorubicin/cyclophosphamide prior to surgery. If residual disease identified after surgery, adjuvant therapy to be determined by the treating oncologist (may include doxorubicin/cyclophosphamide/pembrolizumab, capecitabine etc).
Stage II-III TNBC - estrogen receptor (ER) and progesterone receptor (PR) up to and including 10% is eligible
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Adequate marrow and organ function
Patients unable to undergo PET or MRI
Evidence of metastatic disease or loco-regional recurrence (i.e. distant or chest wall recurrence)
Inflammatory breast cancer
Previous treatment with paclitaxel, carboplatin, or immune checkpoint inhibitors
Sequential
Paclitaxel
Drugchemotherapy
Carboplatin
Drugchemotherapy
Pembrolizumab
Drugimmunotherapy
Doxorubicin
Drugadditional chemotherapy - neoadjuvant or adjuvant rescue
Cyclophosphamide
Drugadditional chemotherapy - adjuvant rescue
Olaparib
Drugadjuvant rescue
Capecitabine
Drugadjuvant rescue
SULmax in relation to pCR
Evaluate if lack of decrease in fluorodeooxyglucose (FDG) / positron emission tomography (PET) standardized uptake value corrected for lean body mass (SULmax) by \<40% after 1 cycle of neoadjuvant therapy correlates with residual disease at the time of surgery.
Pathologic complete response (pCR)
Evaluate the pathologic complete response (pCR) rate in patients with early-stage triple negative breast cancer (TNBC) treated with neoadjuvant chemo-immunotherapy.
Circulating tumor deoxyribonucleic acid (ctDNA) clearance
Evaluate how circulating tumor deoxyribonucleic acid (ctDNA) kinetics collected at pre-treatment, and during and after completion of neoadjuvant treatment correlate with pathologic complete response (pCR) at the time of surgery.
Pathologic complete response (pCR) comparison
Compare the pathologic complete response (pCR) rates among patients who achieved clinical complete response (cCR) by breast magnetic resonance imaging (MRI) and those received "rescue" neoadjuvant AC/pembrolizumab with clinical residual disease (RD) after MRI scan.
Diagnostic accuracy of percent and absolute change between baseline and C1D15 measurements
Evaluate the diagnostic accuracy of percent and absolute change (between baseline and C1D15 measurements), and C1D15 absolute measurements in fluorodeooxyglucose (FDG) / positron emission tomography (PET) standardized uptake value corrected for lean body mass (SULmax) for predicting clinical complete response (cCR) using receiver operating characteristic (ROC) curve.
Clinical complete response (cCR) and pathologic complete response (pCR)
Investigate if clinical complete response (cCR) by MRI is predictive of pathologic complete response (pCR).
Change in microbiome
Number of patients that experienced changes in the microbiome serially over time of residual disease.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Breast Cancer Research Foundation
Collaborator
