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Looking for participantsPhase3

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

Sponsor: Merck Sharp & Dohme LLC

NCT ID: NCT06966700

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sacituzumab tirumotecan (biological), Pembrolizumab (biological), Rescue Medication (drug), Carboplatin (drug)
How long the study runs
Study runs about 114 months (dates as stated)
About the drug or intervention
Sacituzumab tirumotecan — biological: IV infusion · Pembrolizumab — biological: IV infusion · Rescue Medication — drug: Participants receive rescue medication at the investigators discretion, per approved product label. · Carboplatin — drug: IV infusion · Paclitaxel — drug: IV infusion · Doxorubicin — drug: IV infusion · Epirubicin — drug: IV infusion · Cyclophosphamide — drug: IV infusion · Capecitabine — drug: Oral tablet · Olaparib — drug: Oral tablet
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
2,400
Started
2025-06-30
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for breast neoplasms
  • • Phase3 - 2,400 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with breast neoplasms

Where?

  • • London - University College London Hospital ( Site 5301)
  • • Dundee - Ninewells Hospital and Medical School ( Site 5300)
  • • Huddersfield - Huddersfield Royal Infirmary ( Site 5313)
  • • Colchester - Colchester General Hospital ( Site 5307)
  • • +5 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Breast NeoplasmsTriple Negative Breast NeoplasmsHR Low-Positive/HER2-Negative Breast Neoplasms

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2ERPD-L1CD137

What the study is looking for

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓cT1c, N1-N2
  • ✓cT2, N0-N2
  • ✓cT3, N0-N2
  • ✓cT4a-d, N0-N2

Who cannot take part

  • ✗The main exclusion criteria include but are not limited to the following:
  • ✗that has spread (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
  • ✗Has received any prior treatment, including radiation, treatment that goes through your whole body,and/or definitive surgery for currently...
  • ✗Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph...
  • ✗Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
See the full criteria
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 physician 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 Cycle1 Day 1 (C1D1). * 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 C1D1. * 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, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Where Is This Study? (9 UK sites)

University College London Hospital ( Site 5301)

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator02034567890

Ninewells Hospital and Medical School ( Site 5300)

Dundee DD2 1SG, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441382660111

Huddersfield Royal Infirmary ( Site 5313)

Huddersfield HD3 3EA, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441484347100

Colchester General Hospital ( Site 5307)

Colchester CO4 5JL, United Kingdom

Recruiting

Princess Royal University Hospital ( Site 5316)

Orpington BR6 8ND, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+441689864042

St Bartholomew s Hospital ( Site 5302)

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+442073777000

Nottingham University Hospitals NHS Trust ( Site 5314)

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Blackpool Victoria Hospital ( Site 5310)

Blackpool FY3 8NR, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Leicester Royal Infirmary ( Site 5309)

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Study Coordinator+44116 258 6295

How to Get in Touch

Toll Free Number

Sponsor contact

CONTACT

1-888-577-8839 Trialsites@msd.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10