| Titre |
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 |
| Protocole ID |
MK-2870-010 |
| ClinicalTrials.gov ID |
NCT06312176 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
Sacituzumab tirumotecan seul et en association avec pembrolizumab versus traitement au choix du clinicien |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Cristiano Ferrario
|
| Coordonnateur(trice) |
Hend Al-Bizri
514-340-8222 poste 28248
Wagdy Rezk
514-340-8222 poste 28248
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec