EUCTR2016-005112-17-IT进行中（未招募）1 期
Multicenter, randomized, phase II study of neoadjuvant chemotherapy associated or not with zoledronate and atorvastatin in triple negative breast cancers - YAPPETIZER Study - YAPPETIZER
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 154 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
- 154
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.Histologically confirmed diagnosis of non-metastatic operable TNBC subjected to diagnostic core biopsy
- •2.TNBC defined as HER2/ER/PgR negative receptors
- •3.Female, aged = 18 years
- •4.ECOG (Eastern Cooperative Oncology Group) performance status = 1
- •5.Clinical indication for a neoadjuvant approach according to the investigator‘s judgment. The standard chemotherapy will consist of a complete pre-operative treatment with anthracyclines and taxanes (in sequence or combination), including platinum derivatives and dose-dense schedules, according to the best physician choice (BPC)
- •6.Availability of paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for IHC
- •7.Patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to study entry. They must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment
- •8.Written informed consent signed prior to enrolment according to ICH/GCP.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1.Presence of metastatic disease
- •2.Previous investigational treatment for any condition within four weeks prior to study registration
- •3.Treatment with bisphosphonates, denosumab or other drug that, in the investigator’s judgment, affects bone metabolism
- •4.Treatment with statins or other drugs that, in the investigator’s judgment, potentially affect the mevalonate pathway
- •5.Any previous treatment for the currently diagnosed breast cancer, including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy
- •6.Inadequate bone marrow, hepatic or 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 ULN, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
- •c.AST (SGOT), ALT (SGPT) > 2.5 x ULN
- •d.Creatinine > 1.2 x ULN, calcium < 8.6 mg/dL
- •7.Co-existing active infection or concurrent illness that, at the judgment of the investigator, contra-indicate the inclusion of the patient in the study
- •8.Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
- •9.Co-existing dental diseases that form a contraindication to the use of zol
- •10.Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
- •11.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures
- •12.Known hypersensitivity to the active substance, to other bisphosphonates or to any excipients of zoledronate
- •13.Known hypersensitivity to the active substance or to any excipients of atorvastatin. Conditions of rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •14.Anticipation of need for major surgical procedure during the course of the trial
- •15.Pregnant or breast feeding women.
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