Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer

• Status: Completed
• Trial end date: 2020-05-27
• Target enrollment: 0
• Participant gender: Female

Summary

This study was a phase III, multicenter, triple-blind, equivalency clinical trial to determine the therapeutic efficacy and safety between Pertuzumab® (CinnaGen Co.) compared to originator pertuzumab in HER2-positive early breast cancer patients.

Patients were stratified dynamically for random assignment to treatment with either Pertuzumab® (CinnaGen Co.) or originator pertuzumab, and received neoadjuvant TCHP regimen every 3- weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cinnagen
• Treatments: Carboplatin; Docetaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• Female patients aged 18-70 years.

• Diagnosed with locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0), inflammatory (T4d, any N, M0) or operable (T2-3, N0-1, M0), invasive breast cancer.

• Primary tumor > 2 cm in diameter.

• HER2 positive breast cancer confirmed (Tumors must be IHC 3+ or FISH/CISH + for IHC 2+ tumors).

• Baseline LVEF ≥ 55% measured by echocardiography.

• Performance status ECOG ≤ 1

• Signed informed consent.

Exclusion Criteria:

• Metastatic disease (Stage IV) or bilateral breast cancer.

• Previous anticancer therapy or radiotherapy for any malignancy.

• Other malignancy, except for carcinoma in situ of the cervix or basal cell carcinoma.

• Received any investigational treatment within 4 weeks of study start.

• At least 4 weeks since major surgery.

• Uncontrolled hypertension (systolic > 150 and/or diastolic > 100), unstable angina, CHF of any NYHA classification, serious cardiac arrhythmia requiring treatment, history of myocardial infarction within 6 months of enrollment.

• Hematological, biochemical and organ dysfunction:

1. Inadequate bone marrow function: Absolute Neutrophil Count (ANC) < 1500 cells/ µL, Platelet count < 100,000 cells/ µL and Hb < 9 g/dL).

2. Impaired liver function: serum [total] bilirubin > 1.25 x ULN, AST/ALT > 1. 5 x ULN with ALP > 2.5 x ULN

3. Inadequate renal function: serum creatinine > 1.5 x ULN.

• Dyspnea at rest or other diseases which require continuous oxygen therapy.

• Severe uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, etc).

• Current chronic daily treatment with corticosteroids (dose of ≥10 mg Oral prednisolone, or equivalent [excluding inhaled steroids])

• Subjects with known infection with HIV, HBV, and HCV.

• Known hypersensitivity to any of the study drugs or excipients.

• Pregnant and/or lactating women or subjects with reproductive potential not willing to use effective methods of contraception.

• Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)