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

NCT04957212 | Completed Phase 3 Results

• 1 other identifier: PER.CIN.BN.95.III
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

HER2-positive Breast Cancer

Keywords

Pertuzumab; HER2-positive Breast Cancer; Neoadjuvant treatment; Equivalency clinical trial

Outcome Measures

Primary Outcomes (1)

• Breast Pathological Complete Response (bpCR)

  bpCR defined as the absence of invasive neoplastic cells in the breast at microscopic examination of the primary tumor at surgery following primary systemic therapy (ypT0/is)

  18-20 weeks after first intervention

Secondary Outcomes (8)

• Total Pathological Complete Response (tpCR)

  18-20 weeks after first intervention

• Objective Response Rate (ORR)

  18-20 weeks after first intervention

• Rate of Breast-conserving Surgery (BCS)

  18-20 weeks after first intervention

• Safety Assessment Including Treatment Related Adverse Events

  Throughout the study duration (from first visit to week 18-20)

• Abnormal Laboratory Data

  Throughout the study duration (from first visit to week 18-20)

Study Arms (2)

TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel)

EXPERIMENTAL

Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; pertuzumab® (CinnaGen Co.) is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Carboplatin; Drug: Docetaxel

TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel)

ACTIVE COMPARATOR

Study drugs are administered intravenously on a 3-weekly schedule and given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel. Trastuzumab is given at an initial dose of 8 mg/kg, followed by 6 mg/kg; Perjeta® is given at an initial dose of 840 mg, followed by 420 mg. Carboplatin is administered at a dose of AUC6 (area under the plasma concentration-time curve) and docetaxel is given at 75 mg/m2.

Drug: Trastuzumab; Drug: Pertuzumab; Drug: Carboplatin; Drug: Docetaxel

Interventions

Trastuzumab DRUG

An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks

TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel); TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel)

Pertuzumab DRUG

An initial dose of 840 mg, followed by 420 mg every 3-weeks

TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel); TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel)

Carboplatin DRUG

A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks

TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel); TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel)

Docetaxel DRUG

75 mg/m2 every 3-weeks

TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel); TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) \< 1500 cells/ µL, Platelet count \< 100,000 cells/ µL and Hb \< 9 g/dL).
• Impaired liver function: serum \[total\] bilirubin \> 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.

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (44)

Besat Clinic

Rasht, Gilan Province, Iran

Location

Dr. Behrouz Najafi's office

Rasht, Gilan Province, Iran

Location

Dr. Mehdi Mirblouk's office

Rasht, Gilan Province, Iran

Location

Razi Hospital

Rasht, Gilan Province, Iran

Location

Dr. Aboulqasem Allahyari's office

Mashhad, Khorasan Razavi, Iran

Location

Imam Reza Hospital

Mashhad, Khorasan Razavi, Iran

Location

Qaem Hospital

Mashhad, Khorasan Razavi, Iran

Location

Sanabad Hospital

Mashhad, Khorasan Razavi, Iran

Location

Arvand Hospital

Ahvāz, Khozestan, Iran

Location

Baqaei Hospital

Ahvāz, Khozestan, Iran

Location

Shafa Hospital

Ahvāz, Khozestan, Iran

Location

Milad Hospital

Isfahan, Iran

Location

Saba Clinic

Isfahan, Iran

Location

Seyed-Al-Shohada Hospital

Isfahan, Iran

Location

Sheikh Mofid Clinic

Isfahan, Iran

Location

Dr. Behjat Kalantari's office

Kerman, Iran

Location

Javad-Al-Aemeh Clinic

Kerman, Iran

Location

Shahid Bahonar Hospital

Kerman, Iran

Location

Dr. Mehrdad Payende's office

Kermanshah, Iran

Location

Amir Hospital

Shiraz, Iran

Location

Namazi Hospital

Shiraz, Iran

Location

Shahid Faghihi Hospital

Shiraz, Iran

Location

Shams Hospital

Tabriz, Iran

Location

Baqiatallah Hospital

Tehran, Iran

Location

BuoAli Hospital

Tehran, Iran

Location

Dr. Safa Najjar Najafi's office

Tehran, Iran

Location

Ebn-Sina Hospital

Tehran, Iran

Location

Firoozgar Hospital

Tehran, Iran

Location

Imam Khomeini Hospital

Tehran, Iran

Location

Iran-Mehr Hospital

Tehran, Iran

Location

Jam Hospital

Tehran, Iran

Location

Jihad University Clinic

Tehran, Iran

Location

Masih Daneshvari Hospital

Tehran, Iran

Location

Massoud Clinic

Tehran, Iran

Location

Mehrad Hospital

Tehran, Iran

Location

Naft Hospital

Tehran, Iran

Location

Rasool Akram Hospital

Tehran, Iran

Location

Resalat Hospital

Tehran, Iran

Location

Sajjad Hospital

Tehran, Iran

Location

Sina Hospital

Tehran, Iran

Location

Taleghani Hospital

Tehran, Iran

Location

Tehran Hospital

Tehran, Iran

Location

Toos Hospital

Tehran, Iran

Location

Dr.Mortazavizadeh's office

Yazd, Iran

Location

MeSH Terms

Interventions

Trastuzumab; pertuzumab; Carboplatin; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr.Nasim Anjidani
• Organization: Cinnagen Co.

anjidani.n@orchidpharmed.com

0989125477964

Study Officials

• Behrouz Najafi, MD

  Assistant Professor of Hematology and Oncology Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients were randomly assigned to treatment by a central randomization procedure via telephone call for each consecutive eligible patient. Randomization codes were allocated after all eligibility criteria were approved, stratification factors were identified and the informed consent form was signed. After randomization procedure, a code was allocated to each patient that was used as patient identifier throughout the study. The assigned code was denoted by 4 initials (corresponding to the 2 first letter of the first name, the 2 first letter of the first surname) and 3 numbers (center code).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: August 11, 2018
• Primary Completion: May 27, 2020
• Study Completion: May 27, 2020
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Locations

IR (44)