EUCTR2014-004194-16-IT进行中（未招募）1 期
A multicenter, single-arm, phase II study to evaluate the activity of pre-operative zoledronate in triple negative breast cancer patients, according to p53 level - TRIPLE NEGATIVE
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 21 人开始时间: 2015年5月20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
- 21
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
- •Patients with newly diagnosed, untreated, operable triple negative breast cancer (TNBC), intended to definitive breast surgery and suitable for pre-operative therapy with zol.
- •Patients must meet all the following criteria for study entry:
- •- Histologically confirmed diagnosis of non-metastatic operable TNBC subjected to diagnostic core biopsy
- •- TNBC defined as HER2/ER/PgR negative receptors
- •- Age = 18 years old
- •- ECOG (Eastern Cooperative Oncology Group) performance status = 1
- •- Ki67 and p53 expression determined by IHC
- •- Availability of paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for IHC and RT-PCR molecular determinations
- •- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months (female patients) and 6 months (male patients) after discontinuation of treatment.
- •- 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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Patients who meet any of the following criteria will be excluded from study entry:
- •- Presence of metastatic disease
- •- Clinical indication of debulking neo-adjuvant treatment
- •- Previous investigational treatment for any condition within four weeks prior to study registration
- •-Treatment with bisphosphonates, denosumab or other drug that, in the Investigator’s judgment, affects bone metabolism
- •-Treatment with statins or other drugs that, in the Investigator’s judgment, potentially affect the mevalonate pathway
- •- Any previous treatment for the currently diagnosed breast cancer, including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy
- •- Inadequate bone marrow, hepatic or renal function including the following:
- •Hb< 9.0 g/dL, absolute neutrophil count < 1.5 x 109/L, platelets <100 x 109/L
- •Total bilirubin > 1.5 x ULN, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
- •AST (SGOT), ALT (SGPT) > 2.5 x ULN
- •Creatinine > 1.2 x ULN, calcium < 8.6 mg/dL
- •- Co-existing active infection or concurrent illness that, at the judgment of the investigator, contra-indicate the inclusion of the patient in the study
- •- Co-existing dental diseases that form a contraindication to the use of zol
- •- Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
- •- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures
- •- Known hypersensitivity to any excipients of zoledronate
- •- Anticipation of need for major surgical procedure during the course of the trial
- •- Pregnant or breast feeding women.
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