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IRCT20201223049810N1 IRCT 2021-02-02 Nano Daru Pajuhan Pardis Company Evaluation of efficacy and safety of PADYNEX in women with HER2+ metastatic breast cancer Evaluation of efficacy and safety of PADYNEX (Trastuzumab-emtansine, T-DM1, manufactured by Nano Daru Pajuhan Pardis) in women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer: A randomised controlled trial, two-arm, open-label. 2021-01-20 anticipated 150 Complete https://irct.ir/trial/53290 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is based on the method of random permuted blocks. In this study, the following four blocks will be used: AABB, ABAB, ABBA, BBAA, BABA, BAAB First, one of these six blocks is randomly selected and individuals are assigned to two groups based on it (for example, if the first selected block is ABAB, the first patient is group A, the second patient is group B, the third patient is group A, and the fourth patient is assigned to group B. Then the next four blocks are selected and this process will continue until the sample is completed. Randomization will be performed using SAS statistical software version 9.4. 2 Human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer. 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 Nano Daru Pajuhan Pardis) at a dose of 3.6 mg per kg by intravenous infusion every three weeks for 6 cycles. Intervention 2: Control group: 100 women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer, receiving trastuzumab; 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. Yes - There is a plan to make this available What will be shared: In the participants data file, only part of the data will be shared as the main outcome. When: 1 year after publication of result To whom: Researchers working in academic and scientific institutions Conditions: At the request of researchers working in academic and scientific institutions Where to obtain: Hanieh Yadollahi Email: h.yadollahi@nanodaru.com How to obtain: Up to 3 months after request Comments:
public Hanieh Yadollahi
NO. 4, Northern Tak Ave., Attar St., Vanak Sq., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1994754953 +98 21 8864 9082 h.yadollahi@nanodaru.com Nano Daru Pajuhan Pardis Company scientific Hanieh Yadollahi
NO. 4, Northern Tak Ave., Attar St., Vanak Sq., Tehran, Iran
Tehran Iran (Islamic Republic of) 1994754953 +98 21 8864 9082 asalshimi2020@gmail.com Nano Daru Pajuhan Pardis Company Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 75 years Female 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. C50 Malignant neoplasm of breast Treatment - Drugs Treatment - Drugs Intervention group: 50 women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer, receiving Padynex (trastuzumab-emtansine, T-DM1 manufactured by Nano Daru Pajuhan Pardis) at a dose of 3.6 mg per kg by intravenous infusion every three weeks for 6 cycles. Control group: 100 women with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer, receiving trastuzumab; 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. 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). 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. Timepoint: The grade of aspartate 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. Fever. Timepoint: The grade of fever will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Thermometer. Peripheral neuropathy. Timepoint: The grade of peripheral neuropathy will be assessed at 21, 42, 63, 84, 105 and 126 days after starting treatment. Method of measurement: Case report form. Nano Daru Pajuhan Pardis Company Approved 2020-12-03 Ethics committee of Shahid Beheshti University of Medical Sciences Third Floor, Faculty of Medicine, Next to Taleghani Hospital, Evin, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)