KCT0003727尚未招募未知
Phase II Study of Trastuzumab Biosimilar (Herzuma®) plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- Female
入选标准
- •1) Breast tumours suspected of dependence on the phosophoinositide 3 - kinase path (If the PI3K dependency due to metamorphosis or known biological evidence is identified as K-MASTER panel in previously stored or fresh tumor tissues, an increase in the number of PIK3CA hot spot mutations, mammalian target of rapamycin hot spot mutations, or PTEN, all genetic results are reviewed by the lead investigator prior to the registration of the study).
- •2) Women over 19 years old when they received the consent form.
- •3) Overspeated breast cancer of HER2 that has been confirmed organically or cytologically. HER2 positive breast cancer is defined as the HER2 positive breast cancer at the time of = 2.0 days with an Immunohistocheemistry (IHC) score of 3+ or in a gene amplified by the Situ optimization (ISH).
- •4) A person who is judged to be transferable or uncontrolled through an image examination.
- •5) A person who has received two or more treatments for a previously transmitted disease, including trastzumab, targeted for EHR-2 treatment.
- •6) At least one measurable lesion shall be present in accordance with RECEST 1.1.
- •7) Eastern Cooperative Oncology Group (ECOG) performance status is 0 - 1.
- •8) If you have the appropriate key long-term features defined below:
- •9) white blood cell = 3500/mL
- •10) Platelets = 100,000/uL
- •11) Hemoglobin >9.0 g/dL
- •12) Total bilirubin = 1.5x upper limit of normal
- •13) aspartate aminotransferase and alanine aminotransferase < 2.5 x upper limit of normal
- •14) Alkaline phosphatase <2.5x upper limit of normal
- •15) Creatine = 1.5x upper limit of normal or creatinine clearance >60 ml/min (if creatine level is higher)
- •16) Where glycemic control is appropriate: Glycosylated Hemoglobin, Type A1C < 7% and = 126 mg/dL (7.0 mmoL/L)
- •17) The expected life span is three months or more.
- •18) In case the left ventricle construction rate is found to be at least 50% by an ultrasonic examination at the time of registration.
- •19) A person who signed a written test consent form approved by the clinical testing committee of a testing agency.
排除标准
- •1) Pregnant women or women who have been breast-fed for hCG test.
- •2) A person who has received treatment for mammalian target of rapamycin inhibitor or phosophoinositide 3 - kinase inhibitor before.
- •3) A person with symptoms or unstable central nervous system transfer
- •4) Exception: A properly treated brain transfer proven by a baseline CT or MRI scan that does not require dexamethasone (except Frednison =10 mg/day) to treat central nervous system symptoms without proof of progress since the previous scan. Stable dose, which has been maintained at a stable capacity for more than four weeks, is permitted.
- •5) Persons with viral, bacterial and fungal active infections, including: chronic B-type, hepatitis C (positive HCV RNA), HIV-infected persons
- •6) Persons who must use or use food related to Cytochrome P450 3A4 inhibitors for 7 days or less during treatment include: powerful CYP3A4 inhibitors: juice or fruit similar to grapefruit or grapefruitfradil, conivaptan; Intermediate Cytochrome P450 3A44 inhibitor: aerythromcyin, verapamil, atazanavir, delavirine, Fluconazole, dalunavir, diltiazem, impatent, tap, capplicable, capp
- •7) From within seven days of administration of a test medication, those who must use or use UGT1A9 metabolic drugs during the treatment period include: propofol, propranol, dapagliflozin, darexaban, mycophhenolic acid, and tapentadol
- •8) A person who used acetaminophen within 24 hours before and after first administration of Gedatolisib
- •9) A person who uses CYP2D6 metabolite-related medication or food for the duration of the test medication from within 10 days of Gedatolisib administration (10) who currently uses herbal medicine
- •10) A person who underwent major surgery within four weeks of administering a test medication or who did not fully recover after any treatment.
- •11) People with malignant tumor disease within three years of administration of a test medication (exception: cervical cervical endocular cancer treated, pyrophyroid cancer without lymph node transfer, and skin cancer other than melanoma)
- •12) QTc interval >480 msec (based on the average of three electrocardiogram measurements), who has other known QTc delay history or Torsade defectives if he or his family has long or short QT, or Brugada syndrome.
- •13) Those who had the following symptoms or conditions within six months of administration of a test medication had: myocardial infarction, NCI CTCAE v. 5.0 Grade =2, persistence of arrhythmia, atrial fibrillation, coronary/ peripheral arterial bypass, heart failure with symptoms, temporary ischemic stroke, or pulmonary embolism.
- •14) A person with a history of epileptic pneumonia.
- •15) Other psychiatric patients who suffer from suicidal urges, abnormalities in clinical laboratory results that affect clinical drug administration, clinical trial participation, or clinical test results (ex, non-cooperative attitudes, etc.)
研究者
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