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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sacituzumab tirumotecan, Pembrolizumab, Paclitaxel, Nab-paclitaxel.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +35
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug Sacituzumab tirumotecan
IV infusion - Biological Pembrolizumab
IV infusion - Drug Paclitaxel
IV infusion - Drug Nab-paclitaxel
IV infusion - Drug Capecitabine
oral tablet - Drug Liposomal doxorubicin
IV infusion
Primary outcome measures
- Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC) [Time frame: Up to ~38 months]
Secondary outcome measures (12)
- Overall Survival (OS) [Time frame: Up to ~77 months]
- Progression-Free Survival (PFS) (pembrolizumab + sacituzumab tirumotecan + versus sacituzumab tirumotecan) [Time frame: Up to ~57 months]
- Objective Response Rate (ORR) [Time frame: Up to ~57 months]
- Duration of Response (DOR) [Time frame: Up to ~57 months]
- 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) [Time frame: Baseline and up to ~77 months]
- Change from baseline in physical functioning score, on the EORTC QLQ-C30 [Time frame: Baseline and up to ~77 months]
- Change from baseline in emotional functioning score, on the EORTC QLQ-C30 [Time frame: Baseline and up to ~77 months]
- Change from baseline in fatigue score, on the EORTC QLQ-C30 [Time frame: Baseline and up to ~77 months]
- Change from baseline in diarrhea score, on the EORTC QLQ-C30 [Time frame: Baseline and up to ~77 months]
- Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC QLQ-C30 [Time frame: Up to ~77 months]
- TTD in physical functioning score, on the EORTC QLQ-C30 [Time frame: Up to ~77 months]
- TTD in emotional functioning score, on the EORTC QLQ-C30 [Time frame: Up to ~77 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 46 centers
- Ironwood Cancer & Research Centers ( Site 0066) — Chandler
- Banner MD Anderson Cancer Center-Oncology ( Site 0004) — Gilbert
- Providence Medical Foundation-Oncology ( Site 0020) — Fullerton
- Moores Cancer Center ( Site 0059) — La Jolla
- Cancer and Blood Specialty Clinic ( Site 0001) — Los Alamitos
- University of Colorado Anschutz Medical Campus ( Site 0061) — Aurora
- UCHealth Cherry Creek Medical Center ( Site 0094) — Denver
- University of Colorado Health - Highlands Ranch Hospital ( Site 0095) — Highlands Ranch
- … and 38 more centers
Japan · 24 centers
Center list to be confirmed — check the primary protocol.
Poland · 11 centers
Center list to be confirmed — check the primary protocol.
Germany · 9 centers
Center list to be confirmed — check the primary protocol.
Italy · 9 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 8 centers
Center list to be confirmed — check the primary protocol.
Canada · 7 centers
- BC Cancer Surrey ( Site 0315) — Surrey
- Southlake Health ( Site 0311) — Newmarket
- Princess Margaret Cancer Centre ( Site 0310) — Toronto
- CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0301) — Montreal
- Jewish General Hospital ( Site 0303) — Montreal
- CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0302) — Québec
- Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de R — Rimouski
France · 7 centers
Center list to be confirmed — check the primary protocol.
Netherlands · 7 centers
Center list to be confirmed — check the primary protocol.
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Instituto Alexander Fleming-Alexander Fleming ( Site 0382) — Buenos Aires
- Fundacion Estudios Clinicos-Oncology ( Site 0384) — Rosario
- Hospital Aleman-Oncology ( Site 0386) — Buenos Aires
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site — Buenos Aires
- Hospital Italiano de Córdoba ( Site 0385) — Córdoba
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0387) — La Rioja
Brazil · 6 centers
- Oncoclínica Oncologistas Associados-Clinical Research ( Site 0407) — Teresina
- Hospital Moinhos de Vento ( Site 0403) — Porto Alegre
- Hospital do Câncer Mãe de Deus ( Site 0404) — Porto Alegre
- Instituto de Oncologia Saint Gallen ( Site 0412) — Santa Cruz do Sul
- Instituto do Câncer Brasil - Unidade Taubaté ( Site 0408) — Taubaté
- IBCC - Núcleo de Pesquisa e Ensino ( Site 0401) — São Paulo
Chile · 6 centers
- FALP-UIDO ( Site 0451) — Santiago
- Oncovida ( Site 0453) — Santiago
- Clínica RedSalud Vitacura ( Site 0455) — Santiago
- Pontificia Universidad Catolica de Chile ( Site 0454) — Santiago
- Bradfordhill ( Site 0452) — Santiago
- Bradford Hill Norte ( Site 0456) — Antofagasta
Greece · 6 centers
Center list to be confirmed — check the primary protocol.
Hungary · 6 centers
Center list to be confirmed — check the primary protocol.
Mexico · 6 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 6 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 6 centers
Center list to be confirmed — check the primary protocol.
Belgium · 5 centers
- Institut Jules Bordet-Medicine Oncology ( Site 1104) — Anderlecht
- Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1103) — Brussels
- Jessa Ziekenhuis-Limburgs Oncologisch Centrum ( Site 1105) — Hasselt
- AZ Maria Middelares-IKG ( Site 1106) — Ghent
- Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1107) — Namur
Colombia · 5 centers
Center list to be confirmed — check the primary protocol.
Czechia · 5 centers
Center list to be confirmed — check the primary protocol.
Denmark · 5 centers
Center list to be confirmed — check the primary protocol.
South Africa · 5 centers
Center list to be confirmed — check the primary protocol.
Australia · 4 centers
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2002) — Macquarie University
- Westmead Hospital ( Site 2000) — Westmead
- Frankston Hospital-Oncology and Haematology ( Site 2003) — Frankston
- Fiona Stanley Hospital-Medical Oncology ( Site 2004) — Murdoch
India · 4 centers
Center list to be confirmed — check the primary protocol.
Israel · 4 centers
Center list to be confirmed — check the primary protocol.
Peru · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 4 centers
Center list to be confirmed — check the primary protocol.
South Korea · 4 centers
Center list to be confirmed — check the primary protocol.
Costa Rica · 3 centers
Center list to be confirmed — check the primary protocol.
Ireland · 3 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Hong Kong · 2 centers
Center list to be confirmed — check the primary protocol.
Philippines · 2 centers
Center list to be confirmed — check the primary protocol.
Puerto Rico · 2 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06312176 · 2870-010 · MK-2870-010 · 2023-504918-29-00 · U1111-1289-8119 · jRCT2031240476