RECRUITING

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

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Conditions

Breast NeoplasmsTriple Negative Breast NeoplasmsHR Low-Positive/HER2-Negative Breast NeoplasmsProgrammed Cell Death-1 (PD1, PD-1)Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A 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

Quick Facts

Study Start:2025-07-01
Study Completion:2035-02-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06966700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * cT1c, N1-N2
  3. * cT2, N0-N2
  4. * cT3, N0-N2
  5. * cT4a-d, N0-N2
  6. * 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.
  7. * Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
  8. * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization.
  9. * Demonstrates adequate organ function.
  1. * Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
  2. * Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
  3. * Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
  4. * Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  5. * 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).
  6. * Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
  7. * Received prior treatment with a topoisomerase I inhibitor-containing ADC.
  8. * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  9. * Known additional malignancy that is progressing or has required active treatment within the past 5 years.
  10. * Uncontrolled systemic disease.
  11. * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.

Contacts and Locations

Study Contact

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

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Bioresearch Partner ( Site 0072)
Hialeah, Florida, 33013
United States
Mercy Medical Center - Baltimore ( Site 0015)
Baltimore, Maryland, 21202
United States
Cancer Partners of Nebraska ( Site 0068)
Lincoln, Nebraska, 68516
United States
Renown Regional Medical Center ( Site 0041)
Reno, Nevada, 89502
United States
Oncology Consultants P.A. ( Site 0073)
Houston, Texas, 77030
United States
Northwest Medical Specialties, PLLC ( Site 0067)
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-01
Study Completion Date2035-02-04

Study Record Updates

Study Start Date2025-07-01
Study Completion Date2035-02-04

Terms related to this study

Keywords Provided by Researchers

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
  • Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Additional Relevant MeSH Terms

  • Breast Neoplasms
  • Triple Negative Breast Neoplasms
  • HR Low-Positive/HER2-Negative Breast Neoplasms