EUCTR2014-001984-11-IT进行中（未招募）不适用
eo-Adjuvant Treatment with the CDK4,6 inhibitor Palbociclib in HER2-positive and ER-positive breast cancer: effect on Ki67 and apoptosis before, during and after treatment
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E DELLA CURA DEI TUMORI0 个研究点目标入组 32 人开始时间: 2014年10月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
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. Female patients aged 18 years or older with tumors
- •suitable for neoadjuvant treatment
- •2. Early (> 1.5 cm) or locally advanced untreated breast
- •3. Histologically confirmed invasive unilateral breast cancer
- •4. HER2-positive disease centrally confirmed
- •5. Positive estrogen receptor (ER) > 10% and known
- •progesterone receptor (PgR)
- •6. Available paraffin-embedded tumor block taken at
- •diagnostic biopsy for central retrospective confirmation of
- •HER2 and ER eligibility and for assessment of Ki67 value
- •and apoptosis is mandatory
- •7. All patients must agree to provide tumor tissues for
- •centralized assessment of KI67 values and apoptosis at the
- •required timelines (2 weeks from starting protocol therapy
- •and at surgery)
- •8. ECOG performance status 0 or 1
- •9. Written informed consent to participate in the trial
- •(approved by the Institutional Review Board [IRB]/
- •Independent Ethics Committee [IEC]) obtained prior to any
- •study specific screening procedures
- •10. Willing and able to comply with the protocol
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •1. Evidence of bilateral invasive breast cancer or metastatic disease (M1)
- •2. Pregnant or lactating women. Documentation of a negative serum pregnancy test must be available for premenopausal women with intact reproductive organs and for women less than one year after the last menstrual cycle
- •3. Women with childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception, for example abstinence, an intra-uterine device, or double barrier method of contraception up to 7 months from the last dose of either anticancer study drug
- •4. Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy
- •5. Previous extensive radiotherapy
- •6. Previous investigational treatment for any condition within 4 weeks of registration date
- •7. Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol
- •8. Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. Patients with curatively treated basal cell carcinoma of the skin, stage 1 uterine cancer or in situ cervix cancer are generally eligible.
- •9. Other serious illness or medical condition including: history of documented congestive cardiac failure; angina pectoris requiring anti-anginal medication; evidence of transmural infarction on ECG; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
- •10. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multi-gated scintigraphic scan (MUGA)
- •11. QTc >480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP)
- •12. Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and precluding informed consent or adversely affecting compliance with study drugs
- •13. Serious uncontrolled infections (bacterial or viral) or poorly controlled diabetes mellitus
- •14. Current use or anticipated need for food or drugs that are known strong CYP3A4 inhibitors or inducers
- •15. Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
- •16. Any of the following abnormal baseline hematological values:
- •a.Absolute Neutrophil Count (ANC) < 1.5 ? 109/L
- •b.Platelet count < 100 ? 109/L
- •c.Hemoglobin (Hb) < 10 g/dL
- •17. Any of the following abnormal baseline laboratory tests
- •a.Serum total bilirubin > 1.5 ? ULN (upper limit of normal) (except for patients with clearly documented Gilbert’s syndrome)
- •b.Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.25 ? ULN
- •c.Alkaline phosphatase > 2.5? ULN
- •d.Serum creatinine > 1.5 ? ULN
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