Tests sacituzumab tirumotecan against standard treatment in hormone-positive breast cancer
Tests sacituzumab tirumotecan, alone or with pembrolizumab, in adults with advanced hormone-positive breast cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Cork and Dublin, IrelandSee the 3 sitesAlso in 39 other countries, 256 sites
- Trial code
- NCT06312176
- EU 2023-504918-29-00
- JRCT2031240476
- U1111-1289-8119
- Registry title
- A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,200 people, planned
- Started
- 14 Apr 2024
- Expected to end
- 12 Apr 2031
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Sacituzumab tirumotecan
- Pembrolizumab
- Paclitaxel
- Nab-paclitaxel
- Capecitabine
- Liposomal doxorubicin
- Record updated
- 13 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with HR+/HER2- breast cancer that cannot be removed by surgery or has spread. Their cancer must have grown on hormone treatment and they must be able to have chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Breast cancer that is HR+/HER2- (confirmed by a central lab) and either locally advanced and cannot be removed by surgery, or has spread to other parts of the body
- Earlier treatment
- Cancer grew on one or more lines of hormone (endocrine) therapy, one of them together with a CDK4/6 inhibitor. No earlier chemotherapy for advanced or spread breast cancer.
- Biomarker or test result
- Hormone receptor positive (HR+) and HER2 negative (HER2-) breast cancer, confirmed centrally
Main reasons for not taking part
- Breast cancer that can be treated with treatment meant to remove all of the disease
- Cancer came back within 6 months after finishing chemotherapy given before or after surgery
- Spread to organs that causes symptoms and may quickly lead to life-threatening problems
- Autoimmune disease that needed treatment with medicines for the whole body in the past 2 years
- Past or current lung inflammation (pneumonitis or interstitial lung disease) that needs steroids
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced/metastatic HR+/HER2- breast cancer, with one in combination with a CDK4/6 inhibitor
- Is a chemotherapy candidate
- Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has adequate organ function
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Who cannot take part
- Has breast cancer amenable to treatment with curative intent
- Has experienced an early recurrence (<6 months after completing adjuvant/neoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment
- Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
- Active autoimmune disease that has required systemic treatment in the past 2 years
- History of (noninfectious) pneumonitis/interstitial lung disease that requires steroids, or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
- Has symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- What did the tests on your tumour show about hormone receptors and the HER2 protein?
- Have you been treated with a CDK4/6 inhibitor (for example palbociclib, ribociclib or abemaciclib)?
- Have you had chemotherapy for cancer that has spread or is advanced?
Where in Ireland
Also in 39 other countries, 256 sites
- Bon Secours Cork Hospital (Site 1422)Cork, IrelandContact: Study CoordinatorTaking people
- Mater Misericordiae University Hospital-Clinical Trials Research Unit (Site 1423)Dublin, IrelandContact: Study CoordinatorTaking people
- St. Vincent's University Hospital-Medical Oncology Research Department (Site 1420)Dublin, IrelandContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer.
Read full original descriptionShow less
The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
The 3 groups in the trial
- Arm A: Sacituzumab tirumotecanTreatment being tested
Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) via intravenous (IV) infusion until progressive disease or discontinuation.
Treatment: Sacituzumab tirumotecan
- Arm B:Pembrolizumab + Sacituzumab tirumotecanTreatment being tested
Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation PLUS 400 mg of pembrolizumab once every 6 weeks (Q6W) via IV infusion for up to 18 administrations (up to \~2 years).
Treatment: Sacituzumab tirumotecan and Pembrolizumab
- Arm C: Treatment of Physician's Choice (TPC)Existing treatment, for comparison
At the physician's discretion, participants receive chemotherapy of 80 mg/m\^2 of paclitaxel once every week (Q1W) via IV infusion OR 90 mg/m\^2 of paclitaxel once every 4 weeks (Q4W) via IV infusion OR 100 mg/m\^2 of nab-paclitaxel Q4W via IV infusion OR 1000 mg/m\^2 of capecitabine every 3 weeks (Q3W) orally OR 50 mg/m\^2 of liposomal doxorubicin once every 4 weeks (Q4W) via IV infusion, until progressive disease or discontinuation.
Treatment: Paclitaxel, Nab-paclitaxel, Capecitabine, and Liposomal doxorubicin
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer
- Plain-language title
- Tests sacituzumab tirumotecan against standard treatment in hormone-positive breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06312176, who can take part
- Record updated
- 13 October 2026