> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sacituzumab-tirumotecan-mk-2870-as-a-single-agent-eb9a5f10-b63c-46a9-8bac-9150b81ebdeb > Record changed: 2026-10-13 # 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) NCT06312176 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Participants 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Start date 2024-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) Number of sites 259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Short 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Dates **Completion date** 2031-04-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **First posted** 2024-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Primary completion date** 2027-07-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Start date** 2024-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Size and sites **Participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Planned participants** 1,200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Number of sites** 259 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Identifiers **Registry ID** NCT06312176 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **ClinicalTrials.gov ID** NCT06312176 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Outcomes ### Primary outcomes 1. Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice \[TPC\]; pembrolizumab + sacituzumab tirumotecan versus TPC) Timeframe: Up to \~38 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. ### Secondary outcomes 1. Overall Survival (OS) Timeframe: Up to \~77 months OS is defined as the time from randomization to death due to any cause. 2. Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan) Timeframe: Up to \~57 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. 3. Objective Response Rate (ORR) Timeframe: Up to \~57 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. 4. Duration of Response (DOR) Timeframe: Up to \~57 months For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented. 5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Timeframe: Baseline and up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better overall health status. 6. Change from baseline in physical functioning score, on the EORTC QLQ-C30 Timeframe: Baseline and up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better level of physical functioning. 7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30 Timeframe: Baseline and up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better level of emotional functioning. 8. Change from baseline in fatigue score, on the EORTC QLQ-C30 Timeframe: Baseline and up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A lower score indicates a better level of function. 9. Change from baseline in diarrhea score, on the EORTC QLQ-C30 Timeframe: Baseline and up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A lower score indicates a better level of function. 10. Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30 Timeframe: Up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better overall health status. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in global health status/quality of life combined score. 11. TTD in physical functioning score, on the EORTC QLQ-C30 Timeframe: Up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better level of physical functioning. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the physical functioning score. 12. TTD in emotional functioning score, on the EORTC QLQ-C30 Timeframe: Up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A higher score indicates a better level of emotional functioning. TD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the emotional functioning score. 13. TTD in fatigue score, on the EORTC QLQ-C30 Timeframe: Up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the fatigue score. 14. TTD in diarrhea score, on the EORTC QLQ-C30 Timeframe: Up to \~77 months The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question about their diarrhea are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100\. A lower score indicates a better level of function. TTD is defined as the time from baseline to the first onset of a 10-point deterioration from baseline in the diarrhea score. 15. Number of participants who experience one or more adverse events (AEs) Timeframe: Up to \~77 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 16. Number of participants who discontinue study treatment due to an AE Timeframe: Up to \~77 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Sites - Ironwood Cancer & Research Centers ( Site 0066)Chandler, United StatesRecruiting - Banner MD Anderson Cancer Center-Oncology ( Site 0004)Gilbert, United StatesRecruiting - Providence Medical Foundation-Oncology ( Site 0020)Fullerton, United StatesRecruiting - Moores Cancer Center ( Site 0059)La Jolla, United StatesActive, not recruiting - Cancer and Blood Specialty Clinic ( Site 0001)Los Alamitos, United StatesRecruiting - University of Colorado Anschutz Medical Campus ( Site 0061)Aurora, United StatesRecruiting - UCHealth Cherry Creek Medical Center ( Site 0094)Denver, United StatesRecruiting - University of Colorado Health - Highlands Ranch Hospital ( Site 0095)Highlands Ranch, United StatesCompleted - Yale Cancer Center ( Site 0060)New Haven, United StatesRecruiting - Stamford Hospital ( Site 0049)Stamford, United StatesRecruiting - AdventHealth Altamonte Springs ( Site 0021)Altamonte Springs, United StatesRecruiting - University of Florida College of Medicine ( Site 0063)Gainesville, United StatesActive, not recruiting - Orlando Health Cancer Institute ( Site 0011)Orlando, United StatesRecruiting - Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0032)Thomasville, United StatesRecruiting - Rush University Medical Center ( Site 0079)Chicago, United StatesRecruiting - University of Chicago Medical Center ( Site 0067)Chicago, United StatesRecruiting - Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0053)Edgewood, United StatesRecruiting - Mary Bird Perkins Cancer Center-Breast & GYN Pavilion ( Site 0042)Baton Rouge, United StatesRecruiting - Greenebaum Comprehensive Cancer Center ( Site 0036)Baltimore, United StatesRecruiting - Mercy Medical Center - Baltimore-Medical Oncology and Hematology ( Site 0028)Baltimore, United StatesCompleted - Holy Cross Hospital ( Site 0073)Silver Spring, United StatesRecruiting - Dana-Farber Cancer Institute-Breast Oncology Center ( Site 0037)Boston, United StatesRecruiting - Henry Ford Health ( Site 0002)Detroit, United StatesRecruiting - Saint Luke's Cancer Institute ( Site 0027)Kansas City, United StatesRecruiting - Washington University School of Medicine ( Site 0076)St Louis, United StatesRecruiting And 234 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (5) - MK-2870-010 - 2023 - U1111-1289-8119 - 2023-504918-29-00 - jRCT2031240476 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06312176) ## Related records ### Drugs (5) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Sacituzumab tirumotecan](https://trialight.com/data/asset/sacituzumab-tirumotecan-25c916a3-8178-42d0-a6e5-c6d3a4149237.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (18) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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