EUCTR2019-001559-38-ES进行中（未招募）1 期
A Randomized Phase II Study to Evaluate the Incidence of Discontinuations due to Diarrhoea at 3 Cycles in patients with Early-stage HER2-positive (HER2+), Hormone Receptor-positive (HR+) Breast Cancer treated with Neratinib plus Loperamide prophylaxis versus Neratinib with Initial Dose Escalation plus PRN Loperamide prophylaxis versus Neratinib plus Loperamide plus Colesevelam prophylaxis. DIANER Study” - DIANER
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 个研究点目标入组 315 人开始时间: 2021年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 315
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female patient =18 years of age at signing of informed consent.
- •- Histologically confirmed Stage IB through Stage IIIC primary adenocarcinoma of the breast.
- •- Documented HER2-positive disease based on local laboratory determination according to ASCO/CAP 2018 criteria.
- •- Documented hormone receptor-positive (HR+) disease, defined as oestrogen receptor (ER) and/or progesterone receptor (PR) =1% based on local laboratory determination.
- •- Patients must have completed prior neoadjuvant/adjuvant trastuzumab-based therapy (eg, trastusuzmab-based treatments including trastuzumab-emantasine [T-DM1]) or experienced side effects that resulted in early discontinuation of trastuzumab-based therapy that have since resolved (pertuzumab therapy is accepted but not mandatory).
- •- The last dose of trastuzumab-based therapy must have been given to the patient >2 weeks and =1 year (365 days) before first dose of neratinib.
- •- Left ventricular ejection fraction (LVEF) =50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).
- •- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- •- Negative ß-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause. [Women are considered postmenopausal if they are = 12 months without menses, in the absence of endocrine or anti-endocrine therapies].
- •- Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, ie, intrauterine device, bilateral tubal ligation, vasectomized partner, or abstinence (only when it is the preferred lifestyle of the patient), from the time of informed consent until 30 days after the last dose of the medicinal products. Male patient with female partner of childbearing potential must agree and commit to use condom, and the female partner must agree and commit to use a highly effective method of contraception (ie, any of the above methods, or for females, hormonal contraception associated with inhibition of ovulation) while on treatment and for 3 months after last dose of medicinal products.
- •- Recovery (ie, to Grade 1 or baseline) from all clinically significant adverse events (AEs) related to prior therapies (excluding alopecia, neuropathy, and nail changes).
- •- Provide written, informed consent to participate in the study and follow the study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •- Clinical or radiologic evidence of local or regional recurrence of disease or metastatic disease prior to or at the time of study entry.
- •- Currently receiving chemotherapy, radiation therapy, immunotherapy, or biological therapy for breast cancer (adjuvant endocrine therapy is allowed).
- •- Major surgery within <30 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy <14 days prior to the initiation of investigational products.
- •- Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of =2), unstable angina, myocardial infarction within 12 months of enrolment, or ventricular arrhythmia.
- •- QTc interval >0.450 seconds (males) or >0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP).
- •- Screening laboratory assessments outside the following limits:
- •Laboratory Parameters: Required Limit for Exclusion
- •Absolute neutrophil count (ANC): <1,000/µl (<1.0 x 109/L).
- •Platelet count: <100,000/µl (<100 x 109/L).
- •Hemoglobin: <9 g/dL.
- •Total bilirubin: >1.5 x institutional upper limit of normal (ULN) (in case of known Gilbert’s syndrome, <2 x ULN is allowed).
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT): >2.5 x institutional ULN.
- •Creatinine: Creatinine clearance <30 mL/min (as calculated by Cockcroft-Gault formula a or Modification of Diet in Renal Disease [MDRD] formula b).
- •a Cockcroft and Gault, 1976
- •b Levey et al, 1999
- •- Active, unresolved infections.
- •- Patients with a second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Patients with other non-mammary malignancies must have been disease free for at least 5 years.
- •- Currently pregnant or breast-feeding.
- •- Significant chronic gastrointestinal disorder with diarrhoea as a major symptom (eg, Crohn’s disease, malabsorption, or Grade =2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v.5.0] diarrhoea of any etiology at baseline); or gastroparesis, dysphagia, or swallowing disorder.
- •- Clinically active infection with hepatitis B or hepatitis C virus.
- •- Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that could, in the Investigator’s judgment, make the patient inappropriate for this study.
- •- Known hypersensitivity to any component of the investigational products; known allergies to any of the medications or components of medications used in the trial.
- •- Unable or unwilling to swallow tablets.
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