Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
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
Sun Yat-sen University
57 participants
Jun 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)
Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W
IV: 840mg (loading) → 420mg Q3W
240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea
Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)
Locations(1)
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NCT07610720