HER2-positive Breast CancerPhase 3NCT04957212
Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer
A Phase 3 study testing Trastuzumab, Pertuzumab and Carboplatin in people with HER2-positive Breast Cancer, run by Cinnagen at 44 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Trastuzumab, Pertuzumab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 44 sitesIran
- Study dates
- 11 Aug 2018to 27 May 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- 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)
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
Iran44 sites
Arvand Hospital
Ahvāz, Khozestan
Baqaei Hospital
Ahvāz, Khozestan
Shafa Hospital
Ahvāz, Khozestan
Milad Hospital
Isfahan
Saba Clinic
Isfahan
Seyed-Al-Shohada Hospital
Isfahan
Sheikh Mofid Clinic
Isfahan
Dr. Behjat Kalantari's office
Kerman
Javad-Al-Aemeh Clinic
Kerman
Shahid Bahonar Hospital
Kerman
Dr. Mehrdad Payende's office
Kermanshah
Dr. Aboulqasem Allahyari's office
Mashhad, Razavi Khorasan Province
Imam Reza Hospital
Mashhad, Razavi Khorasan Province
Qaem Hospital
Mashhad, Razavi Khorasan Province
Sanabad Hospital
Mashhad, Razavi Khorasan Province
Besat Clinic
Rasht, Gilan Province
Dr. Behrouz Najafi's office
Rasht, Gilan Province
Dr. Mehdi Mirblouk's office
Rasht, Gilan Province
Razi Hospital
Rasht, Gilan Province
Amir Hospital
Shiraz
Namazi Hospital
Shiraz
Shahid Faghihi Hospital
Shiraz
Shams Hospital
Tabriz
Baqiatallah Hospital
Tehran
BuoAli Hospital
Tehran
Dr. Safa Najjar Najafi's office
Tehran
Ebn-Sina Hospital
Tehran
Firoozgar Hospital
Tehran
Imam Khomeini Hospital
Tehran
Iran-Mehr Hospital
Tehran
Jam Hospital
Tehran
Jihad University Clinic
Tehran
Masih Daneshvari Hospital
Tehran
Massoud Clinic
Tehran
Mehrad Hospital
Tehran
Naft Hospital
Tehran
Rasool Akram Hospital
Tehran
Resalat Hospital
Tehran
Sajjad Hospital
Tehran
Sina Hospital
Tehran
Taleghani Hospital
Tehran
Tehran Hospital
Tehran
Toos Hospital
Tehran
Dr.Mortazavizadeh's office
Yazd
About this study
Official title: A Phase III, Randomized, Two-armed, Parallel, Triple-blind, Active-controlled, Equivalency Clinical Trial of Efficacy and Safety Pertuzumab® (CinnaGen Co.) Compared With Perjeta® (Originator Pertuzumab) in Neoadjuvant Treatment of HER2+ Breast Cancer
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.
Read the detailed description
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 stratified dynamically according to two factors: type of breast cancer (inflammatory, locally and operable) and estrogen/ progesterone receptor (ER/PR) (positive or negative) with 1:1 allocation ratio.
Study drugs were administered intravenously on a 3-weekly schedule and were given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel (TCHP regimen).
The primary endpoint was breast pCR (bpCR). Secondary efficacy endpoints included total pCR (tpCR); objective response rate (ORR) and rate of breast-conserving surgery (BCS) for patients for whom mastectomy was planned before treatment (T2-3).
During this study, adverse events (AEs) were monitored continuously. As an adverse event of special interest (AESI), left ventricular ejection fraction (LVEF) decreased was monitored and assessed by echocardiography throughout the study. Immunogenicity was also assessed.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Trastuzumab, Pertuzumab, Carboplatin, Docetaxel
- Keywords
- Pertuzumab, HER2-positive Breast Cancer, Neoadjuvant treatment, Equivalency clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
PertuzumabDrug
An initial dose of 840 mg, followed by 420 mg every 3-weeks
CarboplatinDrug
A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
DocetaxelDrug
75 mg/m2 every 3-weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Carboplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 18-20 weeks after first intervention
Secondary outcomes (8)
Total Pathological Complete Response (tpCR)
tpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0)
Measured: 18-20 weeks after first intervention
Objective Response Rate (ORR)
ORR defined as the proportion of patients who achieved a complete or partial response
Measured: 18-20 weeks after first intervention
Rate of Breast-conserving Surgery (BCS)
Rate of BCS for patients for whom mastectomy was planned before treatment (T2-3)
Measured: 18-20 weeks after first intervention
Safety Assessment Including Treatment Related Adverse Events
Safety assessment, including the incidence of all reported AEs and abnormal laboratory results was done. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
Measured: Throughout the study duration (from first visit to week 18-20)
Abnormal Laboratory Data
Laboratory data including CBC diff have been assessed. All abnormal values were recorded as adverse event.
Measured: Throughout the study duration (from first visit to week 18-20)
Decrease in Left Ventricular Ejection Fraction (LVEF)
LVEF decrease was measured by echocardiography. All cases with a decrease more than 10% from baseline which meet <50%, will be recorded as adverse events.
Measured: every 6 week (from first visit to week 18-20)
Incidence of Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
In this study, LVSD was evaluated by measuring the decrease in LVEF (outcome measure 5) and assessing the clinical symptoms of the study participants based on physician opinion.
Measured: Throughout the study duration (from first visit to week 18-20)
Immunogenicity
The enzyme-linked immunosorbent assay (ELISA) method was used for the assessment of anti-drug antibodies (ADAs).
Measured: Every 3 weeks (from first intervention to week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start11 Aug 2018
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cinnagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Behrouz Najafi, MD, Principal investigator, Assistant Professor of Hematology and Oncology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957212
- Sponsor's protocol ID
- PER.CIN.BN.95.III
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2021
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Two-armed, Parallel, Triple-blind, Active-controlled, Equivalency Clinical Trial of Efficacy and Safety Pertuzumab® (CinnaGen Co.) Compared With Perjeta® (Originator Pertuzumab) in Neoadjuvant Treatment of HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT04957212
- Acronym / sponsor ID
- PER.CIN.BN.95.III
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Pertuzumab, HER2-positive Breast Cancer, Neoadjuvant treatment, Equivalency clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- CinnagenIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2018 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 stratified dynamically according to two factors: type of breast cancer (inflammatory, locally and operable) and estrogen/ progesterone receptor (ER/PR) (positive or negative) with 1:1 allocation ratio.
Study drugs were administered intravenously on a 3-weekly schedule and were given consecutively on the same day in the following sequence: trastuzumab, followed by pertuzumab, carboplatin, and docetaxel (TCHP regimen).
The primary endpoint was breast pCR (bpCR). Secondary efficacy endpoints included total pCR (tpCR); objective response rate (ORR) and rate of breast-conserving surgery (BCS) for patients for whom mastectomy was planned before treatment (T2-3).
During this study, adverse events (AEs) were monitored continuously. As an adverse event of special interest (AESI), left ventricular ejection fraction (LVEF) decreased was monitored and assessed by echocardiography throughout the study. Immunogenicity was also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel) | Experimental | Drug: Trastuzumab, Drug: Pertuzumab, Drug: Carboplatin, Drug: DocetaxelStudy 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. |
| TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel) | Active comparator | Drug: Trastuzumab, Drug: Pertuzumab, Drug: Carboplatin, Drug: DocetaxelStudy 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAn initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks | Drug | TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel), TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel) |
| PertuzumabAn initial dose of 840 mg, followed by 420 mg every 3-weeks | Drug | TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel), TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel) |
| CarboplatinA dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks | Drug | TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel), TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel) |
| Docetaxel75 mg/m2 every 3-weeks | Drug | TCHP regimen (trastuzumab, Perjeta®, carboplatin, and docetaxel), TCHP regimen (trastuzumab, pertuzumab® (CinnaGen Co.), carboplatin, and docetaxel) |
Primary outcome
Breast Pathological Complete Response (bpCR)
Time frame: 18-20 weeks after first intervention
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)
8 secondary outcomes
Total Pathological Complete Response (tpCR)
Time frame: 18-20 weeks after first intervention
Objective Response Rate (ORR)
Time frame: 18-20 weeks after first intervention
Rate of Breast-conserving Surgery (BCS)
Time frame: 18-20 weeks after first intervention
Safety Assessment Including Treatment Related Adverse Events
Time frame: Throughout the study duration (from first visit to week 18-20)
Abnormal Laboratory Data
Time frame: Throughout the study duration (from first visit to week 18-20)
Decrease in Left Ventricular Ejection Fraction (LVEF)
Time frame: every 6 week (from first visit to week 18-20)
Incidence of Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
Time frame: Throughout the study duration (from first visit to week 18-20)
Immunogenicity
Time frame: Every 3 weeks (from first intervention to week 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Behrouz Najafi, MD principal investigator
Assistant Professor of Hematology and Oncology Research Center
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab, Pertuzumab and Carboplatin in people with HER2-positive Breast Cancer, run by Cinnagen at 44 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Pathological Complete Response (bpCR) (time frame: 18-20 weeks after first intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.