JPRN-jRCT2080225333已完成1 期
An Open-label Phase 1b Study of E7090 Monotherapy and in Combination With Other Anticancer Agents in Subjects With Estrogen Receptor Positive (ER+) and Human Epidermal Growth Receptor 2 Negative (HER2-) Recurrent/Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Provide written informed consent.
- •2. Female participants who are age >=18 years at the time of informed consent.
- •3. Post-menopausal or pre/peri-menopausal female (with medical menopause by treatment with a luteinizing hormone-releasing hormone (LHRH) agonist).
- •4. Participants with pathologically confirmed diagnosis of recurrent/metastatic, ER+, HER2 negative breast cancer.
- •5. Participants who have adequate bone marrow and organ function.
- •6. Participants with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG).
- •7. Participants with at least one accessible lesion for biopsy and who agree to undergo a biopsy of accessible lesion.
- •8. Participants who agree to provide archival or fresh tumor tissue.
- •9. Part 2 only: Participants with FGFR positive tumor.
排除标准
- •1. Participants with brain or subdural metastases, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example: radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.
- •2. Participant who have received more than 2 regimen of chemotherapy in the metastatic setting.
- •(Part3 only) Participant who have received more than 1 regimen of chemotherapy in the metastatic setting.
- •3. Participant with inflammatory breast cancer.
- •4. Participant with bilateral breast cancer.
- •5. Participant who have history of active malignancy within the past 24 months.
- •6. Participants with clinically significant cardiovascular impairment.
- •7. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- •8. Concomitant active infection requiring systemic treatment.
- •9. Participants who test positive for human immunodeficiency virus (HIV antibody), or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody and RNA).
- •10. Participants with following ocular disorders:
- •a. Current evidence of Grade 2 or higher corneal disorder
- •b. Current evidence of active retinopathy (example. age-related macular degeneration, central serous chorioretinal disease, retinal tear).
- •11. Participants who received prior treatment with an FGFR inhibitor.
- •12. Females who are pregnant or breastfeeding.
研究者
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