KCT0003774进行中（未招募）未知
Docetaxel plus Atezolizumab plus Herceptin SC and Pertuzumab (TAHP) for Patients with HER2-positive Early Breast Cancer and Subsequent Atezolizumab plus Herceptin SC and Pertuzumab (AHP) Adjuvant tHerapy after Surgery
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 67
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
- 18(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1) Invasive breast cancer confirmed as local advanced, inflammatory, or histologically early breast cancer.
- •2) Primary breast tumor site of > 2cm or right axillary lymph node metastasis confirmed by fine needle aspiration(FNA) (American Joint Committee on Acncer(AJCC) 7th edition, clinical stage IIA-IIIC)
- •3) Eastern Cooperative Oncology Group(ECOG) performance status 0-1
- •4) patient has Human epidermal growth factor receptor type 2(HER2)-positive breast cancer (as 3+ by Immunohistochemistry (IHC) or if 2+ positive is found in Human epidermal growth factor receptor type 2(HER2)-Silver in situ hybridization(SISH) (or Flurescence in situ hybridization(FISH), Chromogenic in situ hybridization(CISH)) test)
- •5) Available biopsy tissue of a primary tumor
- •6) Left ventricular ejection fraction(LVEF) =55% at baseline (Echocardiogram or Multigated Acquisition(MUGA) scan)
- •7) Patient is an adult, female = 18 years old at the time of informed consent
- •8) Women of child bearing potential must have a negative urine or serum pregnancy test result
- •9) Adequate bone marrow function (= Absolute neutrophil conunt(ANC) 1,500/ul, = platelet 100,000/ul, = hemoglobin 9.0 g/dl)
- •10) Adequate kidney function (= serum creatinine 1.5 mg/dl or Creatinine Clearance(CCr) = 50 ml/min)
- •11) Adequate liver function ( = serum bilirubin 2.5 mg/dl, = Aspartae transaminase(AST) / Alanine aminotransferase(ALT) X upper limit of normal (ULN))
- •12) Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
- •13) Agree to informed consent and willing and able to comply with the protocol
- •14) Consent to tissue and blood sample for biomarker
排除标准
- •1) Metastatic breast cancer (Stage IV)
- •2) Tumor size less than 2cm or and N0
- •3) Previous or concomitant malignancy of any other type that could affect compliance with the protocol or interpretation of results. (Except for in situ carcinoma of the cervix or adequately treated non-melanoma skin carcinoma, thyroid papillary cancer or a malignant tumor that did not recur for 5 years.)
- •4) Any previous treatment against including chemotherapy, hormonal therapy
- •5) Administration of a live, attenuated vaccine within 4 weeks before Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- •6) Severe infections within 4 weeks prior to Day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to Day 1
- •7) Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- •8) Active tuberculosis or evidence of active pneumonitis
- •9) History of idiopathic pulmonary fibrosis
- •10) History of clinically significant liver disease, current alcohol abuse, Known active infections for hepatitis B virus or hepatitis C virus
- •A. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible.
- •B. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA
- •C.Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease.
- •11) Uncontrolled hypertension (systolic >150 and/or diastolic >100), unstable angina, congestive heart failure (total New York Heart Association(NYHA) grades), serious cardiac arrhythmia requiring treatment (except for atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months prior to enrollment or Left ventricular ejection fraction(LVEF) < 55%
- •12) Total bilirubin >1.5 X upper normal limit (except for Gilbert’s syndrome), Aspartae transaminase(AST) / Alanine aminotransferase(ALT) > 1.5 X upper normal limit, Alkaline phosphatase(ALP) > 2.5 X upper normal limit
- •13) Immunosuppression or positive human immunodeficiency virus(HIV) test
- •14) Requirement for oxygen therapy, dyspnea at rest, or other disease
- •15) Uncontrolled serious infection
- •16) Uncontrolled serious medical and psychological disease (including active heart disease)
- •17) Patients with prior allogeneic stem cell or solid organ transplantation
- •18) Pregnant or lactating or intending to become pregnant during or within 7 months after the last dose of study treatment
- •19) Known allergy or hypersensitivity to the components of the Investigational product
- •20) History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- •21) Patients who are not available tumor tissue
- •22) In the investigator’s judgment, patient is unable or unwilling to comply with the requirements of the protocol.
研究者
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