JPRN-jRCT2080225360已完成1 期
A Phase 1 study of H3B-6545 in Japanese women with estrogen receptor-positive, HER2 negative breast cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
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
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Subject has a histologically and/or cytologically confirmed diagnosis of ER-positive, HER2-negative breast cancer.
- •Note: Status of ER and HER2 should be diagnosed by method approved by regulatory authority
- •2. Only females, age >=20 years at the time of informed consent.
- •3. Prior therapy for breast cancer in the adjuvant and/or advanced/metastatic setting must have included a minimum of:
- •a) two prior hormonal therapies, or
- •b) one prior hormonal therapy and one prior chemotherapy regimen, or
- •c) one prior hormonal therapy and a CDK4/6 inhibitor.
- •4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- •5. Subject has adequate bone marrow and organ function.
- •6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
- •7. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
排除标准
- •1. Subject with inflammatory breast cancer.
- •2. Subject is currently receiving or has received systemic corticosteroids =<2 weeks prior to starting study drug, or has not fully recovered from side effects of such treatment.
- •3. Subject has active cardiac disease or a history of cardiac dysfunction, including any of the following:
- •a. History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry.
- •b. History of documented congestive heart failure (New York Heart Association functional classification II to IV).
- •c. Documented cardiomyopathy.
- •d. Subject has a left ventricular ejection fraction (LVEF) <50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
- •e. History of any cardiac arrhythmias, eg, ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
- •f. Heart Rate <60 bpm on the screening.
- •g. On screening, any of the following cardiac parameters: PR interval >220 msec, QRS interval >109 msec, or QTcF >450 msec.
- •h. Systolic blood pressure (BP) not deemed clinically controlled by the investigator.
- •4. Subject has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
- •5. Known to be human immunodeficiency virus (HIV) positive.
- •6. Active viral hepatitis (B or C) as demonstrated by positive serology. Subjects with chronic HBV infection is on antiviral therapy is eligible.
- •7. Any adverse event related to previous therapies for breast cancer that has not resolved to =8. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] test).
- •9. Women of childbearing potential who don't agree that both the subject and her partner will use a medically effective method for contraception (as below) throughout the entire study period or for 28 days after study drug discontinuation.
- •If a subject is on oral contraceptives, they should also be using some additional method.
- •10. Alcohol dependency within 6 months before study entry.
- •11. Subject has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
- •12. Diagnosed with meningeal carcinomatosis.
- •13. Subjects with brain or subdural metastases.
- •14. Subject has a known intolerability to any oral antihistamine drug (only for Antihistamine Prophylactic Administration Part and Randomization Part).
- •15. Subject needs to receive systemic or topical usage of either antihistamine or corticosteroid during Cycle 1 (only for Randomization Part).
- •16. Subject has initiated to receive drugs may cause rash 7 days prior to starting study drug.
研究者
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