Recruiting
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
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.
ClinicalTrials.gov IDNCT07610720
PhasePHASE2
Enrollment57
SponsorSun Yat-sen University
Age18 Years
SexFEMALE
Conditions studied
Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
About this study
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.
Interventions
- Drug: Dalpiciclib — Oral CDK4/6 inhibitor (dose modification permitted for toxicity management)
- Drug: Trastuzumab (Herceptin) — Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W
- Drug: Pertuzumab — IV: 840mg (loading) → 420mg Q3W
- Drug: Pyrotinib — 240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea
- Drug: Endocrine Therapy 1 — Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28)
Primary outcomes
- Progression-Free Survival (PFS) (From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.)
Eligibility information
Inclusion Criteria:
1. Females aged 18 to 75 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.
2. Hormone receptor (HR)-positive and HER2-positive.
3. Patients with no evidence of disease progression (including CR, PR, or SD)after 4-8 cycles of first-line systemic anti-tumor therapy.
4. ECOG Performance Status: 0-1.
Exclusion Criteria:
1. Symptomatic active brain metastases or extensive leptomeningeal metastases.
2. History of Grade 3 or 4 allergic reaction related to the study drugs.
3. Currently receiving other anti-tumor therapies.
Study locations
- Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District, Guangdong, GUANGZHOU 510060 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.