JPRN-UMIN000014649进行中（未招募）2 期
A randomized, multicenter, phase II trial comparing neo-adjuvant therapy using pertuzumab and trastuzumab emtansine based on the dual HER2 blockade in patients with operable HER2-positive primary breast cancer(Neo-peaks study)
Japan Breast Cancer Research Group(JBCRG)0 个研究点目标入组 200 人开始时间: 2014年8月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- •First key inclusion criteria
- •1)Age between 20 and 70 years
- •2)Female patients with primary breast cancer which is diagnosed as invasive cancer by needle biopsy or tissue biopsy.
- •3)Resectable primary breast cancer (cT1c-cT3,cN0-cN1,cM0)with a tumor size <=7cm in diameter.
- •4)The invasive component of the primary tumor is confirmed as HER2 positive(IHC 3+ or FISH+)
- •5)ER and PgR statuses are confirmed by IHC
- •6)No previous therapy for breast cancer
- •7)Pt has been confirned as suitable indication for primary systemic therapy
- •8)Pt who are able to undergo imaging evaluation of their primary disease using the same modality of contrast-enhanced MRI or PET/CT before the treatment,during the treatment,and at the end of the treatment.
- •9)Pt with evaluable primary disease using mammary ultrasonography before the treatment,during the treatment,and at the end of the treatment.
- •10)Written informed concents
- •Secondary criteria
- •By the pathological central review, HER2-positive invasive ductal carcionma, estrogen receptor and the Ki67 level has been confirmed.
- •1)ECOG performance status(PS)0-1
- •2)Laboratory test results meet the following criteria
- •neutrophil count=>1,500/mm3
- •Platelet count=>100,000/mm3
- •Hemoglobin=>9.0g/dL
- •Serum creatinine<=1.5xULN
- •AST and ALT<=1.25xULN
- •total bilirubin<=ULM(direct bilirubin<=ULM in case of Gilbert syndrome)
- •ALP<=1.5xULN
- •INR or APTT<=1.5xULN
- •3)Baseline LVEF=>55% measured by echocardiography or MUGA scan.
- •4)No QTc prolongation by ECG
- •5)No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan
- •6)Pt with confirmed menopausal status.
- •7)Pt who are not pregnant or who are confirmed not to be pregnant by pregnancy test(excluding patients who had hysterectomy).
- •8)Fertile patients must agree to use one"highly effective"form of nonhormonal contraception or two "effective" forms of nonhormonal contraception while on study and for more than 7 months after end of study treatment.
- •9)Pt with a positive hepatitis B surface antigen HBs antigen-positive patients cannot be enrolled.
排除标准
- •1) Bilateral breast cancer whether synchronous or metachronous.Patients with controllable LCIS are permitted.
- •2)Pt with axillary lymph node dissection before pre-operative chemotherapy.
- •3)Pt with incisional or excisional biopsies for primary disease or axillary lymph node.
- •4)Pt with multiple malignancies.
- •5)Participation in another clinical trial
- •6)Pt with peripheral neuropathy >=NCI CTCAE v4.03 Grade 2 are excluded.
- •7)Pt with known cardiopulmonary dysfunction within 6 months before the 2nd enrollment are excluded
- •-Symptomatic left ventricular systolic dysfunction, severe cardiac arrhythmia uncontrolled by appropriate treatments.
- •-High-risk uncontrolled arrhythmias
- •-Uncontrolled hypertension,angina pectoris, clinically significant valvular heart disease.
- •-Requires continuous oxygen inhalation therapy.
- •-History of symptomatic congestive heart failure according to NCI CTCAE v4.03 or NYHA classification.
- •8)Pt with a history of myocardial infarction within 12 months before the 2nd enrollment.
- •9)Pt with severe uncontrolled systemic disease
- •10)Pt who have undergone major surgical operations or significant trauma within 28 days before the 2nd enrollment,or who have planned a major surgical operation during this study.
- •11)Pt with severe infectious disease requiring intravenous administration of antibiotics, antiviral agents,or antifungal agents at enrollment.
- •12)Pt with dental caries and/or oral infections requiring treatment.
- •13)Pt with diagnosed of active liver disease caused by autoimmune disease or sclerosing cholangitis.
- •14)Pt with obvious HIV infections.
- •15)Pt who are breast feeding.
- •16)History of uncontrolled seizures,central nervous system disorders,and mental disorders. Pt with diseases that could interfere with the informed consent process and/or compliance with protocol-based procedures as judged by investigator.
- •17)Known hypersensitivity to any of the study drugs or additives,including murine proteins.
- •18)Pt considered unfit as judged by the investigator.
研究者
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