A Phase 2 interventional study of Dalpiciclib and Trastuzumab (Herceptin) in Advanced/Metastatic Breast Cancer and HER2-Positive Metastatic Breast Cancer, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
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.
This is a multicenter, single-arm, open-label, phase II clinical trial evaluating the efficacy and safety of dalpiciclib (a novel oral CDK4/6 inhibitor) combined with anti-HER2 therapy and endocrine therapy as maintenance treatment in patients with hormone receptor-positive (HR+)/HER2-positive metastatic breast cancer who have completed induction systemic therapy without disease progression.
Triple-positive (HR+/HER2+) metastatic breast cancer represents a unique subtype requiring dual pathway inhibition. Current standard first-line induction therapy includes taxane-based chemotherapy combined with trastuzumab and pertuzumab (THP) or pyrotinib (THPy), followed by maintenance with anti-HER2 therapy plus endocrine therapy. However, approximately 50% of patients progress within 18 months during maintenance therapy.
This study explores the addition of dalpiciclib to standard anti-HER2 and endocrine maintenance therapy to prolong progression-free survival. Dalpiciclib, the first domestically developed CDK4/6 inhibitor in China, has demonstrated favorable efficacy and a manageable safety profile in HR+/HER2- advanced breast cancer, with a lower incidence of febrile neutropenia and no observed interstitial lung disease.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 57 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Dalpiciclib · Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab · Drug: Pyrotinib · Drug: Endocrine Therapy 1
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)
Progression-Free Survival (PFS)
Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first
Time frame: 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.
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) per RECIST 1.1
Time frame: 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.
Overall Survival (OS)
Time from enrollment to death from any cause
Time frame: From randomization until the end of the study (approximately 36 months)
Safety and Tolerability
Incidence, type, severity, and relationship of adverse events (AEs) graded by NCI CTCAE v5.0
Time frame: 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.
Disease-Specific Quality of Life Assessed by EORTC QLQ-BR45
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer-Specific Module (EORTC QLQ-BR45). The EORTC QLQ-BR45 contains 45 items divided into functional and symptom scales evaluating breast cancer-specific issues and treatment side effects. All scales range in score from 0 to 100. A higher score for a functional scale represents a higher/healthy level of functioning, whereas a higher score for a symptom scale represents a higher level of breast cancer-related symptomatology or treatment-related problems.
Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Quality of Life Assessed by EORTC QLQ-C30
Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 consists of 30 items incorporating 5 functional scales, 3 symptom scales, a global health status scale, and 6 single items. All scales and single-item measures range in score from 0 to 100. A higher score for a functional scale or global health status represents a higher/healthy level of functioning, whereas a higher score for a symptom scale/item represents a higher level of symptomatology or problems.
Time frame: From the date of enrollment until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years after the last participant completes treatment.
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sun Yat-sen University