EUCTR2019-000710-11-PT进行中（未招募）1 期
Targeting EGFR/ERBB2 with Neratinib in hormone receptor (HR)-positive/HER2-negative HER2-enriched advanced/metastatic breast cancer (NEREA trial) - NEREA
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
- SOLTI
- 入组人数
- 62
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. Patients of both sexes, over 18 years of age with locally advanced or metastatic breast cancer with hormonal receptors and HER2-negative
- •2. Postmenopausal or Premenopausal Women,
- •3. No more than one previous line of chemotherapy for locally advanced or metastatic recurrent disease.
- •4. Disease refractory to CDK4/6 inhibitors.
- •5. Subtype HER2-E according to the PAM50 analysis confirmed by the designated laboratory.
- •6. ECOG =1.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Prior treatment with any TKI directed to ERBB2 (eg, lapatinib, afatinib, dacomitinib, neratinib, tucatinib).
- •2. Previous treatment with a cumulative dose of epirubicin> 900 mg / m2 or a cumulative dose of doxorubicin> 450 mg / m2. If another anthracycline, or more than one anthracycline, has been used, the cumulative dose should not exceed 450 mg / m2 equivalent of doxorubicin.
- •3. Uncontrolled heart disease
- •4. Major chronic digestive disorder with diarrhea as the main symptom
- •5.Women of childbearing or pregnant age
- •6. Pleural effusion, pericardial effusion
- •7. Uncontrolled hypercalcemia
- •8. * Additional malignant neoplasm confirmed to be in progression or have needed active treatment in the last 3 years.
- •9. Presence of active metastases in the CNS or carcinomatous meningitis.
- •10. * History of pneumonitis (non-infectious) that has required steroids or active pneumonitis.
- •11. * Previous solid organ transplant
- •12. Presence of an active infection that requires systemic treatment.
- •13. * Known history of human immunodeficiency virus (HIV) infection.
- •14. * Known history of hepatitis B virus infection or known active hepatitis C virus infection
- •15. Inability or unwillingness to swallow tablets.
- •16. Known hypersensitivity to any of the components of the product under investigation, the need for combined treatment or loperamide.
- •17. Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A4/P-gp isoform of cytochrome P450 within 5 days prior to inclusion.
- •18. * Presence of a psychiatric or substance abuse disorder
- •19. Being pregnant or breastfeeding
研究者
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