IRCT20150303021315N11CompletedPhase 3
A Phase III, randomized, two armed, parallel, triple-blind, active controlled, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (produced by CinnaGen Co.) plus Trastuzumab, Carboplatin and Docetaxel compared with Perjeta® (Pertuzumab, the reference drug, produced by Roche Company) plus Trastuzumab, Carboplatin and Docetaxel in neoadjuvant treatment of HER 2 positive Breast Cancer patients
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CinnaGen company
- Enrollment
- 214
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 70 years (—)
- Sex
- Female
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
- •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
Investigators
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