NCT06312176Recruiting
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)
Summary
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. 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.
Inclusion criteria
• 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
Exclusion criteria
• 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 symptomatic advanced/metastatic visceral spread at risk of rapidly evolving into life-threatening complications • 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czechia, Denmark, Greece, Hong Kong, Hungary, India, Ireland, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom
- Sponsor
- Merck Sharp & Dohme LLC(Industry)
- Protocol no.
- 2870-010
- Conditions
- Breast Neoplasms
- Interventions
- Drug, Biological
Treatments studied
- Sacituzumab tirumotecan
- Pembrolizumab
- Paclitaxel
- Nab-paclitaxel
- Capecitabine
- Liposomal doxorubicin
Locations · 181
- Basel, SwitzerlandUniversity Hospital Basel-Gynecology & Gynecologic Oncology ( Site 1844)Recruiting at this site
- Thun, SwitzerlandSpital Thun ( Site 1840)Recruiting at this site
- Zurich, SwitzerlandBrust-Zentrum ( Site 1841)Recruiting at this site
- Lyon, FranceHopital Prive Jean Mermoz-Oncology ( Site 1246)Recruiting at this site
- Caen, FranceCentre François Baclesse ( Site 1250)Recruiting at this site
- Montpellier, FranceCentre de Cancérologie du Grand Montpellier ( Site 1244)Recruiting at this site
- Nantes, FranceHôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242)Recruiting at this site
- Poitiers, FranceCentre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 1243)Recruiting at this site
- Paris, FrancePitie Salpetriere University Hospital ( Site 1249)Recruiting at this site
- Paris, FranceInstitut Curie-Oncology medical Department ( Site 1240)Recruiting at this site
- Erlangen, GermanyUniversitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1301)Recruiting at this site
- München, GermanyKlinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1303)Recruiting at this site
- Potsdam, GermanyKlinikum Ernst von Bergmann-Frauenklinik ( Site 1305)Recruiting at this site
- Düsseldorf, GermanyUniversitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1311)Recruiting at this site
- Essen, GermanyKliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1300)Recruiting at this site
- Saarbrücken, GermanyCaritasKlinikum Saarbruecken St. Theresia ( Site 1304)Recruiting at this site
- Gera, GermanySRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1315)Recruiting at this site
- Berlin, GermanyHelios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1314)Recruiting at this site
- Meldola, ItalyIRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1480)Recruiting at this site
- Aviano, ItalyCRO-IRCCS ( Site 1478)Recruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1472)Recruiting at this site
- Milan, ItalyIstituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1475)Recruiting at this site
- Rozzano, ItalyIstituto Clinico Humanitas ( Site 1476)Recruiting at this site
- Bologna, ItalyIRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1474)Recruiting at this site
- Genova, ItalyOspedale San Martino ( Site 1479)Recruiting at this site
- Milan, ItalyOspedale San Raffaele-Oncologia Medica ( Site 1471)Recruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1477)Recruiting at this site
- Chandler, United StatesIronwood Cancer & Research Centers ( Site 0066)Recruiting at this site
- Gilbert, United StatesBanner MD Anderson Cancer Center-Oncology ( Site 0004)Recruiting at this site
- Fullerton, United StatesProvidence Medical Foundation-Oncology ( Site 0020)Recruiting at this site
In total, worldwide, 181 of the 259 sites listed in the registry are recruiting; the other 78 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 13, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 151 more locations
Other identifiers
- MK-2870-010 · other identifier
- 2023-504918-29-00 · other registry
- U1111-1289-8119 · other registry
- jRCT2031240476 · other registry
- 2023 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.