NCT06556862尚未招募2 期
Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase II Study
Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study and sign the informed consent form
- •aged ≥ 18 years.
- •ECOG PS score: 0-2 points.
- •Expected survival ≥ 6 months.
- •Regionally recurrent or metastatic disease with histologically or cytologically confirmed ER+ and/or PR+ (≥ 10%), HER2- breast cancer that is not suitable for definitive excision or radiation therapy.
- •Previously received antitumor therapy: 1) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; 2) Disease recurrence and/or metastasis during or after treatment with Palbociclib or Abemaciclib or Ribociclib in the setting of (neo-)adjuvant therapy, or during treatment with palbociclib or Abemaciclib or Ribociclib in a metastatic setting or after disease progression; 3) No more than 3 lines of endocrine therapy have been previously received for recurrent or metastatic breast cancer. 4) Line number of previous chemotherapy ≤1 line
- •At least one extracranial measurable lesion as defined by RECIST v1.1;
- •The function of vital organs meets the requirements;
- •Absolute neutrophil count ≥ 1.5 × 10^9/L;
- •Platelets ≥ 90 × 10^9/L;
- •Hemoglobin ≥ 90g/L;
- •Total bilirubin (TBIL) ≤ 1.5 × ULN;
- •ALT and AST ≤ 2.5 × ULN;
- •Urea/blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;
- •Left ventricular ejection fraction (LVEF) ≥ 50%;
- •The QT correction by the Fridericia formula (QTcF) is < 470 ms. INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
- •Subject recovers from any AE related to previous antitumor therapy before the first administration of the study drug (Grade ≤ 1)
排除标准
- •Previously received treatment with histone deacetylase inhibitor (HDACi);
- •Previously received Dalpiciclib;
- •MRI or lumbar puncture confirmed leptomeningeal metastasis;
- •Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;
- •The participants presented with visceral crisis (such as lymphangitis carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver function), rapid disease progression, and that is not suitable for endocrine therapy;
- •Participants had ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, which required drainage within 4 weeks before the first medication;
- •Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;
- •Subjects that are diagnosed with any other malignancy within 5 years prior to the study, excluding non-melanoma skin cancer treated with radical therapy, basal or squamous cell skin cancer or carcinoma in situ of the cervix and papillary thyroid.
- •The subject has undergone major surgery or major trauma or is expected to undergo major surgery within 4 weeks before the start of treatment;
- •A known history of allergy to the drug ingredient of this protocol.
研究组 & 干预措施
Dalpiciclib + plus HDACi
Experimental
Dalpiciclib + plus HDACi + Endocrine therapy (doctor's choice)
干预措施: Enitinostat (Drug)
Dalpiciclib + plus HDACi
Experimental
Dalpiciclib + plus HDACi + Endocrine therapy (doctor's choice)
干预措施: Dalpiciclib (Drug)
Dalpiciclib + plus HDACi
Experimental
Dalpiciclib + plus HDACi + Endocrine therapy (doctor's choice)
干预措施: Chidamide (Drug)
结局指标
主要结局
PFS
时间窗: 1 Year
Progression-free survival: The time to the date of first documented progression or date of death from any cause, whichever came first
次要结局
- ORR(2 months)
- CBR(2 Years)
- DoR(2 Years)
- OS(2 Years)
- DCR(2 Years)
- Safety(AE recorded from infromed consent to 28 days after treatment completion)
研究者
Wang Tao
Professor
Beijing 302 Hospital
研究点 (1)
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