NCT05862610尚未招募2 期
A Prospective, Randomized, Controlled Phase II Clinical Study of Trilaciclib Combined With Standard Treatment Project As a Neoadjuvant Treatment For Triple Negative Breast Cancer
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
- 入组人数
- 150
- 主要终点
- The incidence of CIN
研究概览
简要总结
To evaluate the efficacy and safety of trilaciclib combined with standard treatment project as a neoadjuvant treatment for triple negative breast cancer
详细描述
Trilaciclib indication: Trilaciclib, a CDK4/6 inhibitor, was used before chemotherapy to reduce the incidence of bone marrow suppression and approved by the FDA for small cell lung cancer patients in 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Newly treated patients aged ≥ 18 years;
- •ECOG score 0-1;
- •Breast cancer meets the following standards:
- •Histologically confirmed invasive breast cancer
- •Tumor staging: cT2-4, cNany, cM0 or cT1, cN1-3, cM0;
- •Hormone (estrogen and progesterone) receptor negative tumors confirmed by histological or cytological records (defined as nuclear staining rate<1% based on immunohistochemistry [IHC] evaluation) and Her-2 negative, non overexpressing tumors (based on IHC [0 or 1+] or in situ hybridization [ratio<2.0] or average Her-2 gene copy number<4 signals/nucleus);
- •Within the first two weeks of the screening period, no G-CSF, TPO, IL-11, ESA, iron, platelet transfusion, or blood transfusion have been used.
- •The functional level of the main organs must meet the following requirements:
- •Blood routine: Neutrophils (ANC)≥1.5×109/L, platelet count (PLT)≥90×109/L, hemoglobin (Hb)≥90g/L
- •Blood biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, serum creatinine (Cr)≤1.5×ULN, bilirubin<1.5 ULN;
- •For female patients who have not undergone menopause or surgical sterilization: During the treatment period and at least 7 months after the last dose in the study treatment, consent to abstinence or use effective contraceptive methods.
- •Volunteer join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
排除标准
- •Previously received anti-tumor treatment for any malignant tumor;
- •Subjects who are unable to accept or tolerate preoperative chemotherapy due to various reasons;
- •The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgical procedures;
- •Serious heart disease or discomfort, including but not limited to the following diseases:
- •A confirmed history of heart failure or systolic dysfunction (LVEF<50%);
- •High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate>100bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (such as Mobitz II second degree atrioventricular block or third degree atrioventricular block);
- •Angina pectoris requiring treatment with anti angina drugs;
- •Heart valve disease with clinical significance;
- •ECG shows transmural myocardial infarction;
- •Poor control of hypertension (systolic blood pressure>180mmHg and/or diastolic blood pressure>100mmHg)
- •Those with a known history of allergies to the drug components of this protocol;
- •Breastfeeding female patients, those with fertility and positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication;
- •Any other circumstances in which the researcher believes that the patient is not suitable to participate in this study.
研究组 & 干预措施
Trilaciclib plus chemotherapy (Trilaciclib+AC-T)
Experimental
Trilaciclib: 240mg/m2 IV d1,within 4h before chemotherapy epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles
干预措施: Trilaciclib plus chemotherapy (Drug)
Chemotherapy (AC-T)
Experimental
epirubicin: 100mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles cyclophosphamide:600mg/m2 IV d1,Q2W/Q3W (decided by researchers),4 cycles albumin-bound paclitaxel:100mg/m2 IV d1,8,15,Q3W,4cycles
干预措施: Chemotherapy (Drug)
结局指标
主要结局
The incidence of CIN
时间窗: From date of randomization until the date of surgery, assessed up to 6 months
The incidence of ≥3 grade neutropenia
次要结局
- pCR rate(From date of randomization until the date of surgery, assessed up to 6 months.)
- The incidence of CIT(From date of randomization until the date of surgery, assessed up to 6 months)
- OS(From date of randomization until the date of death(up to 24 months))
- The incidence of CIA(From date of randomization until the date of surgery, assessed up to 6 months)
- Adverse event(Frame:From date of randomization until the date of toxicity or PD (up to 24 months))
- ORR(From date of randomization until the date of PD (up to 24 months))
- DFS(From date of randomization until the date of toxicity or PD (up to 24 months))
研究者
相似试验
尚未招募
2 期
Trilaciclib Combined With Chemotherapy for Perioperative Treatment of OsteosarcomaOsteosarcomaNCT06217003The First Affiliated Hospital of Xinxiang Medical College20
终止
2 期
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)Triple-Negative Breast NeoplasmsBreast NeoplasmBreast CancerTriple-Negative Breast CancerNCT02978716G1 Therapeutics, Inc.102
进行中（未招募）
3 期
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast CancerHER-2 Positive Breast CancerEstrogen Receptor Positive Breast CancerNCT02947685Alliance Foundation Trials, LLC.518
招募中
2 期
Trilaciclib Combing Chemotherapy in the Neoadjuvant Treatment of OsteosarcomaOsteosarcomaNCT06714383Peking University People's Hospital50
已完成
3 期
Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First LineHormone Receptor Positive TumorHER 2 Negative Breast CancerBreast CancerNCT03462251iOMEDICO AG41