Equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company)
- Conditions
- Breast cancer.Malignant neoplasm of breast of unspecified siteC50.9
- Registration Number
- IRCT20150303021315N11
- Lead Sponsor
- CinnaGen company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 214
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
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 < 1500/µLPlt < 100,000/µLHb< 9 g/dLALT/AST > 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathologic Complete Response. Timepoint: before intervention and 3-5 weeks After last intervention. Method of measurement: Pathology laboratory.
- Secondary Outcome Measures
Name Time Method 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.