drugset
drugset / Trial / NCT07610720

Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer

NCT07610720 ↗

Phase 2 Recruiting 57 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast Cancer.

Timeline

Start
2026-06-01
Primary completion
2028-11-01
Completion
2029-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule — Oral
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Pyrotinib Small molecule 320 mg —
Background Anastrozole Other / unclassified 1 mg —
Background Exemestane Small molecule 25 mg —
Background Fulvestrant Small molecule 0.5 g Intramuscular
Background Letrozole Other / unclassified 2.5 mg —
Background Trastuzumab Monoclonal antibody 6 mg/kg Subcutaneous
Background Trastuzumab Monoclonal antibody 600 mg Subcutaneous

Indications

HER2 positive breast carcinoma