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Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Sponsor: Sun Yat-sen University
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.
Official title: Evaluating the Efficacy and Safety of Dalpiciclib Plus Anti-HER2 Therapy and Endocrine Therapy in Patients With Induction-Treated Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2026-06-01
Completion Date
2029-11-01
Last Updated
2026-05-28
Healthy Volunteers
No
Interventions
Dalpiciclib
Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)
Trastuzumab (Herceptin)
Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W
Pertuzumab
IV: 840mg (loading) → 420mg Q3W
Pyrotinib
240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea
Endocrine Therapy 1
Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)
Locations (1)
Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District
Guangdong, GUANGZHOU, China