breast cancer patients with HER2-positive. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: All patients are scheduled to receive Doxorubicin + Cyclophosphamide/Docetaxel+AryoTrust regimen as detailed bellow: Doxorubicin + Cyclophosphamide phase: (Cycle le
Sponsors
Aryogen pharmed Company
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 18-70 years old female patients Patients with newly diagnosed stage III(locally advanced) or in-operable stage II (due to sizes larger than 5 cm or high tumor to breast ratio) tumors are candidates for participation Willing and able to sign an informed consent Pathological diagnosis of adenocarcinoma of the breast ECOG status of 0-1 With any ER/PR status HER2 positive
Exclusion criteria
Exclusion criteria: Clinical or radiologic evidence of metastatic disease History of any other malignancy including previous breast cancer, second non-breast malignant disease History of previous chemotherapy Left ventricular ejection fraction [LVEF] 100 mmHg or systolic > 200 mmHg) A severe conduction abnormality (having pacemaker or diagnosed by the ECG) and any other significant cardiovascular disease Hematologic abnormalities including baseline Absolute NeutrophilCount (ANC) of=1,500/µL or platelet count = 100,000/µL Liver dysfunction including : Alanine amino transferase(ALT) and/or aspartate amino transferase (AST) =3 Upper Limit Normal (ULN), Alkaline phosphatase (ALP) =3 ? ULN serum, total bilirubin > 1.5 ULN Renal dysfunction, defined as serum creatinin =2.5 mg/dL Pregnant, lactating women or women of childbearing potential who are not willing to use adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response (pCR). Timepoint: following completion of neoadjuvant systemic therapy. Method of measurement: the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Complete Response (cCR). Timepoint: after completion of neoadjuvant systemic therapy. Method of measurement: Disappearance of lesions in imaging. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.;Clinical Partial Response (cPR). Timepoint: after completion of neoadjuvant systemic therapy. Method of measurement: At least a 30% decrease in the sum of diameters of target lesions through imaging.;Clinically Stable Disease (cSD). Timepoint: after completion of neoadjuvant systemic therapy. Method of measurement: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD through imaging.;Clinical Progressive Disease (cPD). Timepoint: after completion of neoadjuvant systemic therapy. Method of measurement: at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm through imaging.;Clinical Objective Response(cOR). Timepoint: after completion of neoadjuvant systemic therapy. Method of measurement: cOR= cCR+ cPR.;Breast conservation rate. Timepoint: After surgery. Method of measurement: number of mastectomy or Breast conservative surgery.;Immunogenicity. Timepoint: Week 10, 13, 19 and 26. Method of measurement: Laboratory results.;Adverse events. Timepoint: Every cycle. Method of measurement: Laboratory data and patient assessments. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSomayeh Amini
Orchid pharmed Company
Outcome results
None listed