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Purpose

Researchers are looking for new ways to treat types of breast cancer that are both: - High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment - Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: - Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy - Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
sac-TMT 		Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m^2 IV infusion Q3W/Q2W for 4 doses.
  • Biological: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • Sac-TMT
    • MK-2870
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • Keytruda®
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
  • Drug: Carboplatin
    IV infusion
    Other names:
    • Paraplatin
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • Taxol
    • Onxol
  • Drug: Doxorubicin
    IV infusion
    Other names:
    • ADRIAMYCIN®
  • Drug: Epirubicin
    IV infusion
    Other names:
    • Ellence®
  • Drug: Cyclophosphamide
    IV infusion
    Other names:
    • Cytophosphane
  • Drug: Capecitabine
    Oral tablet
    Other names:
    • Xeloda®
  • Drug: Olaparib
    Oral tablet
    Other names:
    • LYNPARZA®
Active Comparator
Chemotherapy 		Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m^2 Q3W and either doxorubicin 60 mg/m^2 Q3W or epirubicin 90 mg/m^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • Keytruda®
  • Drug: Rescue Medication
    Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).
  • Drug: Carboplatin
    IV infusion
    Other names:
    • Paraplatin
  • Drug: Paclitaxel
    IV infusion
    Other names:
    • Taxol
    • Onxol
  • Drug: Doxorubicin
    IV infusion
    Other names:
    • ADRIAMYCIN®
  • Drug: Epirubicin
    IV infusion
    Other names:
    • Ellence®
  • Drug: Cyclophosphamide
    IV infusion
    Other names:
    • Cytophosphane
  • Drug: Capecitabine
    Oral tablet
    Other names:
    • Xeloda®
  • Drug: Olaparib
    Oral tablet
    Other names:
    • LYNPARZA®

Recruiting Locations

Bioresearch Partner ( Site 0072)
Hialeah, Florida 33013
Contact:
Study Coordinator
888-577-8839

Fort Wayne Medical Oncology and Hematology ( Site 0084)
Fort Wayne, Indiana 46804
Contact:
Study Coordinator
888-577-8839

New England Cancer Specialists ( Site 0051)
Westbrook, Maine 04092
Contact:
Study Coordinator
207-303-3300

Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland 21202
Contact:
Study Coordinator
410-951-7956

Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska 68516
Contact:
Study Coordinator
402-327-7363

Renown Regional Medical Center ( Site 0041)
Reno, Nevada 89502
Contact:
Study Coordinator
775-982-4000

Altru Health System ( Site 0057)
Grand Forks, North Dakota 58201
Contact:
Study Coordinator
701-780-5451

Nashville General Hospital ( Site 0017)
Nashville, Tennessee 37208
Contact:
Study Coordinator
615-341-4383

Oncology Consultants P.A. ( Site 0073)
Houston, Texas 77030
Contact:
Study Coordinator
713-275-3233

Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington 98405
Contact:
Study Coordinator
253-428-8700

More Details

NCT ID
NCT06966700
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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