Phase 3
N=214
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
HER2-positive Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04957212 ↗Enrolled (actual)
214
Serious AEs
18.2%
Results posted
Jul 2024
Primary outcome: Primary: Breast Pathological Complete Response (bpCR) — 71; 73 Participants — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Trastuzumab (Drug); Pertuzumab (Drug); Carboplatin (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cinnagen
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Pathological Complete Response (bpCR) |
71; 73 | 0.54 |
| SECONDARY Total Pathological Complete Response (tpCR) |
60; 68 | 0.26 |
| SECONDARY Objective Response Rate (ORR) |
64; 61; 30; 29; 2; 3 | 0.99 |
| SECONDARY Rate of Breast-conserving Surgery (BCS) |
20; 21; 44; 37; 0; 1 | 0.56 |
| SECONDARY Safety Assessment Including Treatment Related Adverse Events |
107; 107 | — |
| SECONDARY Abnormal Laboratory Data |
— | — |
| SECONDARY Decrease in Left Ventricular Ejection Fraction (LVEF) |
— | — |
| SECONDARY Incidence of Symptomatic Left Ventricular Systolic Dysfunction (LVSD) |
— | — |
| SECONDARY Immunogenicity |
0; 0 | — |
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.
Eligibility 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:
- Inadequate bone marrow function: Absolute Neutrophil Count (ANC) 1.25 x ULN, AST/ALT > 1. 5 x ULN with ALP > 2.5 x ULN
- 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)
Data sourced from ClinicalTrials.gov (NCT04957212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.