Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
avril 2024
avril 2031
28 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:11 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Cancérologie du Grand Montpellier ( Site 1244) - 34070 - Montpellier - Languedoc-Roussillon - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre François Baclesse ( Site 1250) - 14076 - Caen - Calvados - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Hôpital privé du Confluent SAS-Service d'oncologie médicale ( Site 1242) - 44277 - Nantes - Loire-Atlantique - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Hopital Prive Jean Mermoz-Oncology ( Site 1246) - 69008 - Lyon - Rhone-Alpes - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut Curie-Oncology medical Department ( Site 1240) - 75248 - Paris - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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