Breast cancer. Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention 1: Intervention group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and given consecutively on the same day in the following sequence: trastuzumab, foll
pertuzumab is given at an initial dose of 840 mg, followed by 420 mg. Intervention 2: Control group: Control group: Study drugs are administered intravenously on a 3-weekly schedule for 6 cycles, and
Perjeta® in group B is given at an initial dose of 840 mg, followed by 420 mg.
Sponsors
CinnaGen company
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Female patients aged 18 - 70 Operable (T2-3, N0-1, M0), locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0), or inflammatory (T4d, any N, M0) breast cancer Primary tumor diameter should be more than 2 centimeters Positive HER2 status approved by immunohistochemistry (IHC 3+ or IHC 2+ verified by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 LVEF =55% at baseline assessed by echocardiography Able and willing to sign an informed consent
Exclusion criteria
Exclusion criteria: Metastatic (stage IV) or bilateral breast cancer Previous systemic or local anticancer therapy for any cancer Any other malignancy except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin Use of another research drug in the four weeks before the start of the study Major surgery four weeks before the start of the study Uncontrolled hypertension (systolic blood pressure more than 150 mmHg or/and diastolic blood pressure more than 100 mmHg) Inadequate bone marrow, liver, or renal function:ANC 1.5 ULN (upper limit of normal)ALP > 2.5 ULNTotal serum bilirubin > 1.25 ULNSerum creatinine > 1.5 ULN Shortness of breath during rest or any other disease that requires continuous oxygen therapy Any severe uncontrolled systemic disease (cardiovascular, pulmonary, metabolic, etc.) Chronic treatment with corticosteroids with a daily dose of = 10 mg oral prednisolone or equivalent of other types (other than inhaled corticosteroid drugs) Patients with HIV, HBV, and HCV infections Hypersensitivity to any of the studied drugs or excipients Pregnant, lactating or fertile women who do not want to use contraceptive methods (contraceptives should be taken in to consideration up to six months after the last dose of the drug) Unwillingness or inability to fulfill the requirements of the protocol, including any kind of condition (physical, mental or social) that affects one's ability to fulfill the requirements of the protocol unstable angina congestive heart failure of any class of NYHA (New York Heart Association) serious cardiac arrhythmia needs treatment history of myocardial infarction within 6 months prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response. Timepoint: before intervention and 3-5 weeks After last intervention. Method of measurement: Pathology laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate. Timepoint: before intervention and 3 weeks after last intervention. Method of measurement: Physical examination and imaging (MRI).;Rate of breast-conserving surgery. Timepoint: 3-5 weeks after last intervention. Method of measurement: Physician report.;Safety. Timepoint: Every 3 weeks. Method of measurement: Patient’s history and laboratory data.;Immunogenicity. Timepoint: Every 3 weeks. Method of measurement: Blood test and antidrug antibody presence evaluating.;Total pathological complete response in breast and axillary lymph nodes. Timepoint: 3-5 weeks After last intervention. Method of measurement: Pathology laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nasim Anjidani
Orchid Pharmed Company
Outcome results
None listed