Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer.
Primary:
To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0) at the time of surgery, as assessed by local pathologist in all participants. Hypothesis (H1): Sac-TMT followed by carboplatin/paclitaxel is superior to chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0), as assessed by local pathologist in all participants.
PACLITAXEL
Pembrolizumab (MK-3475)
Sacituzumab Tirumotecan, MK-2870
- RWJBarnabas Health
- Clara Maass Medical Center
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Newark Beth Israel Medical Center
- Robert Wood Johnson University Hospital, Somerset
- Trinitas Hospital and Comprehensive Cancer Center
- Rutgers University
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: - Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the investigator based on radiological and/or clinical assessment: - cT1c, N1-N2 - cT2, N0-N2 - cT3, N0-N2 - cT4a-d, N0-N2 - The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. - Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization. - Demonstrates adequate organ function. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: - Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement - Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer - Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment. - Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. - Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137). - Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC). - Received prior treatment with a topoisomerase I inhibitor-containing ADC. - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. - Known additional malignancy that is progressing or has required active treatment within the past 5 years. - Uncontrolled systemic disease. - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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