Phase II Study of Herzuma plus Gedatolisib in Patients with HER-2 Positive Metastatic Breast Cancer Who Progressed after 2 or more HER-2 directed Chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0003727
- Lead Sponsor
- Korea University Anam Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 62
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.
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.)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In the case of HER-2 metastatic breast cancer , the merging therapy of trrastumab biosimilar (herzuma®) and gedatolisib is to find out the objective response rate.
- Secondary Outcome Measures
Name Time Method progression-free survival;Quality of life analysis;overall survival