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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib | Drug | Oral CDK4/6 inhibitor (dose modification permitted for toxicity management) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients achieving Complete Response (CR) or Partial Response (PR) per RECIST 1.1 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Doctor Chen, PhD / Doctorate | Contact | 02087341812 | chenmt@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun yat-Sen University Cancer Center, Guangzhou, Yuexiu District | Recruiting | Guangdong | GUANGZHOU | 510060 | China |
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| Trastuzumab (Herceptin) | Drug | Subcutaneous, 600mg Q3W; IV: 8mg/kg (loading) → 6mg/kg Q3W |
|
| Pertuzumab | Drug | IV: 840mg (loading) → 420mg Q3W |
|
| Pyrotinib | Drug | 240mg qd Week 1 → 320mg qd from Week 2 (max dose); loperamide prophylaxis for diarrhea |
|
| Endocrine Therapy 1 | Drug | Letrozole 2.5mg, Anastrozole 1mg, Exemestane 25mg, or Fulvestrant 0.5g IM on Days 1, 28 (initial: Days 1, 15, 28) |
|
| Overall Survival (OS) |
Time from enrollment to death from any cause |
| 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 | 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. | 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. | 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. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| C000622954 | pyrotinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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