NCT07132749Enrolling By Invitation不适用
A Prospective, Observational, Multicenter Cohort Study Evaluating the Efficacy and Safety of NEPA (Netupitant/Palonosetron) in Patients With HER2-positive or HER2-low Advanced Breast Cancer Treated With T-DXd
Yeon Hee Park1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete response (CR: no emesis and no rescue medication)
研究概览
简要总结
This clinical trial is a prospective, observational, multicenter cohort study evaluating the efficacy and safety of NEPA (netupitant/palonosetron) in patients with HER2-positive or HER2-low advanced breast cancer treated with T-DXd
详细描述
The observation period of this study is until the discontinuation after administration of T-Dxd or until 8 Cycle.
- Acute phase: 0 -24 hours after T-DXd administration
- Delayed phase: >24-120 hours after T-DXd administration
- Overall phase: 0-120 hours after T-DXd administration
- Long-delayed phase: >120-504 hours
- Extended overall phase: 0-504 hours
Primary objectives: to evaluate the efficacy and safety of NEPA for CINV prevention in advanced breast cancer patients receiving at least 2 cycles of T-DXd across all defined assessment periods (acute, delayed, overall, long-delayed, and extended overall phases).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >19 years
- •Histologically confirmed breast cancer with metastatic or locally advanced breast cancer not amenable to definitive surgery, with or without measurable disease
- •Stage IV breast cancer at initial diagnosis (de novo) or progression at distant metastatic sites following curative surgery
- •HER2-positive breast cancer (HER2 IHC 3+ or IHC 2+/ISH-positive) or HER2-low breast cancer (HER2 IHC 2+/ISH-negative or HER2 IHC 1+), as defined by the ASCO/CAP guidelines
- •ECOG performance status 0-2
- •Patients who are scheduled to initiate their first cycle of T-DXd therapy
- •Patients who are scheduled to receive netupitant/palonosetron (NEPA) for the prevention of acute and delayed CINV according to the approved indications and dosage instructions
- •Patients who agree to use highly effective contraception methods or not of childbearing potential. Highly effective contraception methods include:
- •A. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •B. Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your "tubes tied") at least six weeks before taking study treatment.
- •C. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- •D. Combination of the following:
- •I. Placement of an intrauterine device (IUD) or intrauterine system (IUS) II. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository
- •Written informed consent
排除标准
- •Patients who experienced nausea and/or vomiting within 7 days prior to the first cycle of T-DXd treatment
- •Leptomeningeal metastasis and/or brain metastasis
- •Patients with hypersensitivity to any components of the drug or 5-HT3 receptor antagonists.
- •Pregnant women or those suspected of being pregnant, as well as breastfeeding mothers.
- •Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering T-DXd or NEPA to the patient.
- •Patients requiring treatment with steroids, antiemetics, benzodiazepines, antipsychotics, or other contraindicated drugs, including but not limited to pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, fluvoxamine, SSRIs, SNRIs, ritonavir, or nelfinavir.
结局指标
主要结局
Complete response (CR: no emesis and no rescue medication)
时间窗: At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks
CR during the long-delayed phase(\>120-504 hours)
次要结局
- Complete response (CR: no emesis and no rescue medication)(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- Complete control (CC: no emesis, no rescue medication and no or mild nausea)(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- Total control (TC: no emesis, no rescue medication and no nausea)(At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks)
- No significant nausea (NSN: defined as no or mild nausea)(At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks)
- No nausea(At the end of first Cycle 2 of T-DXd (each cycle is 28 day), assessed up to 6 weeks)
- CR rate(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- NSN rate(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- no nausea rate(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- Proportion of patients who receive rescue medications(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- Proportion of patients undergoing T-DXd dose delay(At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks)
- Proportion of patients requiring permanent discontinuation(At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks)
- Health-related quality of life (EQ-5D-5L)(At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks)
- FACIT Fatigue(At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks)
- CTCAE v5.0(At the end of first documented progression or first Cycle 8 of T-DXd (each cycle is 28 days), assessed up to 24 weeks)
- Daily rescue medication rate(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
- Duration of rescue medication(At the end of first Cycle 2 of T-DXd (each cycle is 28 days), assessed up to 6 weeks)
研究者
Yeon Hee Park
professor
Samsung Medical Center
研究点 (1)
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