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
Inclusion Criteria4
- Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
- Hormone receptor (HR)-positive and HER2-positive.
- Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
- ECOG Performance Status: 0-1.
Exclusion Criteria3
- Symptomatic active brain metastases or extensive leptomeningeal metastases.
- History of Grade 3 or 4 allergic reaction related to the study drugs.
- Currently receiving other anti-tumor therapies.
Interested in this trial?
Get notified about updates and connect with the research team.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07610720