Human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: 50 women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer, receiving Padynex (trastuzumab-emtansine, T-DM1 manufactured by Nan
Loading dose of 8 mg per kg body weight of patients, and 3 weeks after loading dose, maintenance dose of 6 mg per kg body weight by intravenous infusion, every three weeks for 6 cycles.
Sponsors
Nano Daru Pajuhan Pardis Company
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Women aged 18-75 years Metastatic breast cancer (Metastasis to intraperitoneal solid organs, lungs, pleura, or multiple bones) Based on histological, cytological and imaging results. HER2+ (immunohistochemistry 3+, HER2 gene amplification in fluorescence in situ hybridization positive or positive HER2 result in Chromogenic in situ hybridization). Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors, version 1.1, (the minimum size of a measurable lesion at baseline should be no less than double the slice thickness (when CT scans have slice thickness greater than 5 mm, the minimum size for a measurable lesion should be twice the slice thickness)). Life expectancy of more than 12 weeks based on a physician or treatment team estimate. Acceptable clinical test results at the beginning of the study based on the normal range of the reporting laboratory An Eastern Cooperative Oncology Group performance status of 0–2 All the patients provided written informed consent.
Exclusion criteria
Exclusion criteria: History of type 1 allergic/anaphylactic infusion reactions to any component of the PADYNEX formulation History of treatment with trastuzumab-emtansine Patients with locally advanced breast cancer and non metastatic History of second non-breast cancer in last 5 year Patients with brain metastasis Serious concurrent disease (chronic kidney disease stage 4,5, hepatic impairment child pugh class c, bronchiectasis, severe chronic obstructive pulmonary disease, severe asthma, pulmonary fibrosis) Peripheral neuropathy of grade 3 or worse (as per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) Left ventricular ejection fraction lower than 50% (as measured by echocardiography) within previous 3 months, myocardial infarction or congestive heart failure within previous 6 months, high-risk uncontrolled arrhythmias; clinically significant valvular disease; concomitant medication for the treatment of unstable angina, uncontrolled blood pressure (higher than 200/100 mmHg), severe electrical conduction defect (having a pacemaker or electrocardiogram diagnosis) or Any other significant heart disease. Blood disorders such as baseline absolute neutrophil count lower or equal to 1,500 per microliter or platelet count lower or equal to 100,000 per microliter. Alanine aminotransferase/ aspartate aminotransferase higher or equal to 2.5 upper limit of normal. Pregnancy, breast-feeding, and women of childbearing potential not using contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate. Timepoint: before starting treatment, 77 and 105 day after starting treatment. Method of measurement: computerized tomography scan or Magnetic resonance imaging, According to Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain score. Timepoint: Pain score will be assessed at 21, 42, 63, 84, 105 and 126 days after starting the treatment. Method of measurement: The grade (severity) of pain will be assessed by visual analog scale.;Vomiting. Timepoint: The grade of Vomiting will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Case report form.;Diarrhea. Timepoint: The grade of diarrhea will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Case report form.;Constipation. Timepoint: The grade of constipation will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Case report form.;Neutropenia. Timepoint: The grade of neutropenia will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Taking a blood test from the patient; Nihon Kodhen ES Hematology Analyzer based on flow cytometry method.;Anemia. Timepoint: The grade of anemia will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Taking a blood test from the patient; Nihon Kodhen ES Hematology Analyzer based on flow cytometry method.;Leukopenia. Timepoint: The grade of leukopenia will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Taking a blood test from the patient; Nihon Kodhen ES Hematology Analyzer based on flow cytometry method.;Thrombocytopenia. Timepoint: The grade of thrombocytopenia will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Taking a blood test from the patient; Nihon Kodhen ES Hematology Analyzer based on flow cytometry method.;Alanine aminotransferase levels. Timepoint: The grade of alanine aminotransferase will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: BT3500 analyzer based on enzymatic method.;Aspartate aminotransferase levels. Time | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHanieh Yadollahi
Nano Daru Pajuhan Pardis Company
Outcome results
None listed