Efficacy and Safety of Mecapegfilgrastim for Prophylaxis of Dalpiciclib -Induced Neutropenia in Patients With Advanced HR+/HER2- Breast Cancer: a Open-label, Multicenter, Investigator-initiated, Randomized Controlled Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days)
研究概览
简要总结
Neutropenia is a common complication from dalpiciclib. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. The study aim to evaluate the safety and efficiency of mecapegfilgrastim for prophylaxis of dalpiciclib -induced neutropenia in patients with advanced HR+/HER2- breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Pathologically confirmed advanced HR+/HER2- breast cancer: there is evidence of focal recurrence or metastasis, which is not suitable for surgical resection or radiotherapy for the purpose of cure.
- •No more than one line of chemotherapy is allowed for patients with recurrent and metastatic diseases.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •For patients with brain metastases, there is need for local treatment, and the brain lesions are stable for ≥ 3 months, and no need for dexamethasone or mannitol.
- •Adequate organ function: (I) adequate hematologic function: hemoglobin ≥90 g/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥100×109/L; (II) adequate renal and hepatic function.
- •Negative pregnancy test.
排除标准
- •Previous pathological diagnosis of HER2 positive breast cancer.
- •Previous treatment with cdk4/6 inhibitors.
- •Major surgery, chemotherapy, radiotherapy, any research drug or other anti-cancer treatment within 2 weeks before entering the trial.
- •Any other malignant tumor diagnosed within 3 years before entering the study, except non-melanoma skin cancer, basal cell or squamous cell skin cancer or cervical carcinoma in situ after radical treatment.
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 1000 IU/ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method) or combined hepatitis B and hepatitis C co-infection.
- •Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe / unstable angina pectoris, NYHA grade 2 or above cardiac insufficiency, persistent arrhythmia ≥ grade 2 (according to nci-ctcae version 5.0), atrial fibrillation at any level, coronary / peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).
- •Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.
研究组 & 干预措施
Mecapegfilgrastim +dalpiciclib + endocrine therapy
Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
干预措施: Mecapegfilgrastim (Drug)
Mecapegfilgrastim +dalpiciclib + endocrine therapy
Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
干预措施: dalpiciclib (Drug)
Mecapegfilgrastim +dalpiciclib + endocrine therapy
Mecapegfilgrastim / dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
干预措施: exemestane, fulvestrant, letrozole, tamoxifen (Drug)
dalpiciclib + endocrine therapy
dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
干预措施: dalpiciclib (Drug)
dalpiciclib + endocrine therapy
dalpiciclib / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)
干预措施: exemestane, fulvestrant, letrozole, tamoxifen (Drug)
结局指标
主要结局
The incidence of grade ≥3 neutropenia at the end of cycle 1 (each cycle is 28 days)
时间窗: at the end of cycle 1 (each cycle is 28 days)
The incidence of grade ≥3 neutropenia in cycle 1: defined as ANC \<1.0×109/L at the end of Cycle 1 (each cycle is 28 days).
次要结局
- The incidence of grade ≥3 neutropenia at the end of all cycles (each cycle is 28 days)(through study completion, an average of 2 years)
- Progression-free Survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Breast-Q scores(through study completion, an average of 2 years)
- Overall Survival(From date of randomization until the date of death from any cause, assessed up to 60 months)
- Relative dose intensity of dalpiciclib(through study completion, an average of 2 years)
- Objective response rate (ORR）(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
研究者
Jieqiong Liu, M.D., Ph.D.
Associate Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University