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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
干预措施: Endocrine Therapy 1 (Drug)
Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
干预措施: Dalpiciclib (Drug)
Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
干预措施: Trastuzumab (Herceptin) (Drug)
Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
干预措施: Pyrotinib (Drug)
Dalpiciclib + Endocrine Therapy + Trastuzumab ± Pertuzumab or Pyrotinib
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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.
Time from enrollment to radiographic disease progression (per RECIST 1.1) or death from any cause, whichever occurs first
次要结局
- Objective Response Rate (ORR)(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)(From randomization until the end of the study (approximately 36 months))
- Safety and Tolerability(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(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(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.)
研究者
Jia-Jia Huang
Department of Medical Oncology Professor, Principal Investigator, Chief Physician
Sun Yat-sen University