EUCTR2019-001896-35-PT进行中（未招募）1 期
An Open-Label Phase 2 Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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
- •1. Aged >=18 years at signing of informed consent.
- •2. Histologically confirmed stage 1 through stage 4 primary adenocarcinoma of the breast.
- •3. Documented HER2 overexpression or gene-amplified tumor by a validated approved method.
- •4. Patients with confirmed stage 1 to 3c breast cancer receiving neratinib monotherapy must have completed a course of prior adjuvant trastuzumab or experienced side effects that resulted in early discontinuation of trastuzumab that have since resolved.
- •5. Patients with mBC must have had at least 2 prior HER2-directed regimens.
- •6. Left ventricular ejection fraction (LVEF) >=50% measured by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO).
- •7. Eastern Cooperative Oncology Group (ECOG) status of 0 to 1.
- •8. 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.
- •9. Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, i.e., 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 28 days after the last dose of the investigational products. Men (male patient) with a 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 (i.e., 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 investigational products.
- •10. Recovery (i.e., to Grade 1 or baseline) from all clinically significant AEs related to prior therapies (excluding alopecia, neuropathy, and nail changes).
- •11. No major bleeding diathesis or use of anticoagulants that would pose a high risk for endoscopic procedure.
- •12. 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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Patients with confirmed stage 1 through stage 3c breast cancer currently receiving chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer.
- •2. Patients with mBC that have received prior capecitabine or HER2 directed TKI therapy.
- •3. Currently using drugs that have been implicated as causing microscopic colitis/watery diarrhea, such as acarbose, aspirin, proton pump inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), histamine H2 receptor antagonists, selective serotonin reuptake inhibitors, and ticlopidine.
- •4. Major surgery within <28 days of starting treatment or received chemotherapy, investigational agents, or other cancer therapy, except hormonal therapy (eg, tamoxifen, aromatase inhibitors), <14 days prior to the initiation of investigational products.
- •5. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of >=2; including individuals who currently use digitalis, beta-blockers, or calcium channel blockers specifically for congestive heart failure), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.
- •6. QTc interval >0.450 seconds (males) or >0.470 (females), or known history of QTc prolongation or Torsade de Pointes (TdP).
- •7. Diagnosis of inflammatory bowel disease.
- •8. Screening laboratory assessments outside the following limits:
- •- Absolute neutrophil count (ANC): =<1000/µl (=<1.0 x 10^9/L)
- •- Platelet count: =<100000/µl (=<100 x 10^9/L)
- •- Hemoglobin: =<8 g/dL (transfusions allowed). Transfusions must be at least 14 days prior to initiation of treatment.
- •- 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 (>5 x ULN if liver metastases are present in mBC patients)
- •- Creatinine: Creatinine clearance <30 mL/min (as calculated by Cockcroft-Gault formula or Modification of Diet in Renal Disease [MDRD] formula)
- •- International Normalized Ratio (INR): >=1.5
- •9. Active, unresolved infections.
- •10. 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.
- •11. Currently pregnant or breast-feeding.
- •12. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (eg, Crohn’s disease, malabsorption, or Grade >=2 National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events Version 4.0 [CTCAE v.4.0] diarrhea of any etiology at baseline).
- •13. Clinically active infection with hepatitis B or hepatitis C virus.
- •14. 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.
- •15. Known hypersensitivity to any component of the investigational products; known allergies to any of the medications or components of medications used in the trial.
- •16. Unable or unwilling to swallow tablets.
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