EUCTR2018-001856-36-IT进行中（未招募）1 期
A RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE THE ACTIVITY OF ATRA IN COMBINATION WITH ANASTROZOLE IN PRE-OPERATIVE PHASE OF OPERABLE HR-POSITIVE/HER2-NEGATIVE EARLY BREAST CANCEREBC ATRA TRIAL - eBC ATRA TRIA
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 112 人开始时间: 2021年6月8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
- 112
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
- Female
入选标准
- •1.Signed, informed consent
- •2.Histologically confirmed non-metastatic operable primary invasive HR-positive breast cancer subjected to diagnostic core biopsy
- •3.Menopausal status
- •4.HR-positive/HER2-negative eBC defined as
- •-ER>1% on immunohistochemistry (IHC) staining
- •-HER2 score equal to 0, 1+, 2+ (if FISH neg) on IHC staining
- •5.Available paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for Ki67 determination (IHC)
- •6.Adequate bone marrow, hepatic and renal function including the following
- •a.Hb = 9.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelets =100 x 109/L
- •b.Total bilirubin = 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
- •c.AST (SGOT), ALT (SGPT) = 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases)
- •d.Creatinine = 1.5 x upper normal limit
- •7.Age = 18 years
- •8.Performance status (PS) = 1 (ECOG scale).
- •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 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
排除标准
- •1.Presence of metastatic disease
- •2.Pre-menopausal status
- •3.Previous investigational treatment for any condition within 4 weeks of randomization date
- •4.Treatment including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy for the currently diagnosed breast cancer prior to study entry
- •5.Co-existing active infection or serious concurrent illness
- •6.Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
- •7.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- •8.Gastrointestinal disorders that may interfere with absorption of the study drug.
研究者
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