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IRCT20150303021315N16 IRCT 2019-11-24 Aryogen Evaluation of AryoTrust administration in treatment of breast cancer مطالعه پایش ایمنی داروی آریوتراست Post-marketing surveillance for evaluation of AryoTrust safety in Iranian HER2-positive breast cancer patients under adjuvant chemotherapy regimens 2017-12-22 anticipated 597 Complete https://irct.ir/trial/41825 observational Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Other. 4 Breast cancer. Intervention group: patients are treated with 6mg/kg trastuzumab (produced by AryoGen pharmed) every 3 weeks in adjuvant setting, for 12 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no intention for the company to do.
public Banafshe Ghomian
Attar Sq.
Tehran Iran (Islamic Republic of) 9174564582 +98 21 4347 3524 ghomian.b@orchidpharmed.com orchid pharmed co scientific Dr Fatemeh Homaei
Koohsangi Ave.
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3842 6936 HomaeeF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients diagnosed with non-metastatic HER2 positive breast cancer after treatment with adjuvant chemotherapy (trastuzumab in combination with doxetaxel or paclitaxel weekly for 12 weeks or others regimens) who are candidates for trastuzumab maintenance therapy 6 mg/kg every 3 weeks for 12 months 18 years no limit Both - Patients who received Herceptin - Patients who are not candidates for trastuzumab maintenance therapy after adjuvant chemotherapy C50.919 Malignant neoplasm of unspecified site of unspecified female breast Treatment - Drugs Intervention group: patients are treated with 6mg/kg trastuzumab (produced by AryoGen pharmed) every 3 weeks in adjuvant setting, for 12 months Ejection fraction decreased. Timepoint: Every 3 weeks. Method of measurement: echocardiography. Peripheral oedema. Timepoint: Every 3 weeks. Method of measurement: physical examination. Tachycardia. Timepoint: Every 3 weeks. Method of measurement: heart rate counting. Hypotension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter. Hypertension. Timepoint: Every 3 weeks. Method of measurement: blood pressure meter. Nausea- Vomiting- Diarrhoea- Abdominal pain. Timepoint: Every 3 weeks. Method of measurement: medical history and physical examination. Headache- Fatigue- Insomnia- Dizziness- Paresthesia. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination. Neutropenia- Anaemia- Febrile neutropenia. Timepoint: Every 3 weeks. Method of measurement: CBC complete blood count. Rash- Nail disorder. Timepoint: Every 3 weeks. Method of measurement: physical examination. Arthralgia- Bone pain- Back pain. Timepoint: Every 3 weeks. Method of measurement: Medical history and physical examination. Chills- Pyrexia- Angioedema. Timepoint: Every 3 weeks. Method of measurement: thermometer. Influenza like illness- Infection. Timepoint: Every 3 weeks. Method of measurement: lab data. Aryogen Approved 2017-11-15 Regional ethics committee of Mashhad university of medical sciences Research chancellor, Mashhad University of Medical Sciences, 18th Daneshgah St., Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)