breast cancer. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: in interventional group:at first course of therapy:1-carboplatin 150mg(AUC>6) 2- docetaxel 75mg/kg 3- Trastuzumab (Aryogen) 8mg/kg. at next 5 course of therapy the same medicines are
Treatment - Drugs
in interventional group:at first course of therapy:1-carboplatin 150mg(AUC>6) 2- docetaxel 75mg/kg 3- Trastuzumab (Aryogen) 8mg/kg. at next 5 course of therapy the same medicines are used but only Tr
in control group:at first course of therapy: 1-carboplatin 150mg(AUC>6) 2- docetaxel 75mg/kg 3- Trastuzumab (Herceptin) 8mg/kg. at next 5 course of therapy the same medicines are used but only Hercep
Sponsors
AryoGen Biopharma Company
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:older than 18 years; HER2 positive (3+) in IHC test or (2+) with positive FISH test; size of tumor more than 2cm; ECOG grade between 0-1; LVEF more than 55%; complete inform consent form Exclusion criteria:metastatic breast cancer; bilaterally breast cancer; other neoplasms; bone marrow failure; renal failure; liver failure; heart failure; uncontroled hypertension; pregnancy during study or planning for pregnancy at the beginning of study. .
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological response of breast tumor according to sataloff criteria. Timepoint: 18 weeks after beginning of neoadjuvant therapy. Method of measurement: pathological evaluation of breast biopsy by pathologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Amplitude of probable hematologic side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: by laboratory tests.;Amplitude of probable fever side effect. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical,by phisician.;Amplitude of probable gastrointestinal side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical and by laboratory tests.;Amplitude of probable Pulmonary side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical,by phisician.;Amplitude of probable Cardiac side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical,by phisician.;Amplitude of probable renal side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical and by laboratory tests.;Amplitude of probable neurologic side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical,by phisician.;Amplitude of probable allergic side effects. Timepoint: once weekly after beginning of neoadjuvant therapy. Method of measurement: clinical,by phisician. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Kamran Kamyar
AryoGen Biopharma Company
Outcome results
None listed