KCT0006154尚未招募未知
Phase II trial of anti-HER2 treatment in HER2-enriched early breast cancer identified by PAM50, HER2E-PAM, PAMILIA study)
Yonsei University Health System, Gangnam Severance Hospital0 个研究点目标入组 59 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1) Pathologically and cytologically documented unsectable/metastatic breast cancer that :
- •A. has confirmed HER2 negative expression regardless hormone receptor status
- •- definition of HER2 negative breast cancer
- •i) HER2 IHC 1+ without ISH or
- •ii) HER2 IHC 2+ and ISH negative (average HER2 gene copy number <4 signals/cell in single probe ISH
- •or HER2/CEP17 ratio <2.0 & average HER2 gene copy number <4 signals cell in dual-probe ISH)
- •2) No prior treatment of stage II-III breast cancer
- •- HR+ & HER2- breast cancer : cT1-4N1-3
- •- HR- & HER2- breast cancer : cT1N1-3 or cT2-4N0-3
- •3) No systemic metastasis confirmed by pathological or radiological evaluation
- •4) Patients over 19 years
- •5) Confirmed to HER2-enriched subtype by PAM50 study
- •6) Available FFPE 15-20 slides for evaluating PAM50 study
- •7) ECOG 0-1
- •8) Adequate bone marrow functions
- •i) Hemoglobin= 9g/dL
- •ii) ANC =1,500/mm3
- •iii) Platelet =100,000/mm3
- •9) Adequate renal functions
- •i) creatinine : = 1.5 x UNL or
- •ii) creatinine clearance (Ccr) = 50 ml/min by Cockroft formula
- •10) Adequate liver functions
- •i) Bilirubine : = 1.5 x UNL
- •ii) AST/ALT : = 2.5 x UNL
- •11) Adequate cardiac functions
- •- LVEF =50% (with MUGA scan or TTE)
- •12) Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
- •13) Written informed consent.
排除标准
- •1) History of previous treatments of ipsilateral or contralateral invasive breast cancer
- •2) Confirmation of systemic distant metastasis of breast cancer
- •3) History of other malignancy within the last 5 years, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, less than 2cm of thyroid cancer (papillary, follicular, medullary).
- •4) inflammatory breast cancer (cT4d)
- •5) bilateral breast cancer(except, multifocal or multicentric breast cancer)
- •6) occult breast cancer
- •7) History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)
- •8) Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment
- •9) Uncontrolled infections and other serious diseases or medical conditions
- •10) Uncontrolled hyeprtension or clinically active cardiovascular disease: for example, cerebrovascular accident or transient isschemic attack, unstable angina, myocaridal infarction within 6 months prior to enrolment. Have symptomatic congestive heart failure (CHF; New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
- •11) Have any condition (eg, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures or suggest that the patient is, in the investigator’s opinion, not an appropriate candidate for the study
- •12) Patients who are hypesenstivie reaction to experimental drugs (doxorubicin, cyclophosphamide, paclitaxel, docetaxel, herzuma)
- •13) Peripheral neuropathy CTCAE v4.03 = grade 2
研究者
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