A Phase 3 interventional study of Trastuzumab and Pertuzumab in HER2-positive Breast Cancer, sponsored by Cinnagen. Completed at 44 sites in Iran, Islamic Republic of. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Cinnagen · Phase 3, Interventional, and Treatment
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Among 103 studies testing pertuzumab in Breast Neoplasms — 25 open to participants now, 44 under way, 7 of them phase 3. pertuzumab · Breast Neoplasms.
Among the 103 studies testing pertuzumab in Breast Neoplasms, this one is the 34th largest by enrollment, is one of 6 that started in 2018, is one of 23 in phase 3, and was the 61st registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →25 of the 103 studies testing pertuzumab in Breast Neoplasms are open now, in 11 countries. Recruiting first, the newest first:
Wen-Ming Cao · Sites in China
Ages 60+ · Women only
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–90
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70 · Women only
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
Alliance for Clinical Trials in Oncology · Sites in United States, Puerto Rico
Ages 18+
By country, each count listing its studies:
pertuzumab: first FDA approval 2012 (PERJETA), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, pertuzumab is the treatment under test here. Read study by study →
103 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 63 · Phase 3 23 · Phase 4 3
First in 2003; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 214 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 100 across the 103 interventional studies. Of the 50 that completed or were terminated, 34 (68%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 103 have an industry lead sponsor. The 10 most frequent:
Cinnagen is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Cinnagen has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
10 of the studies testing pertuzumab in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT05891561Shanghai Jiao Tong University School of MedicineShort-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer | 2026-12 |
| NCT07095023Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer | 2026-12-30 |
| NCT07187752Shandong Cancer Hospital and InstituteIdentification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes | 2026-12-31 |
| NCT04733118MedSIRChemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer | 2027-03 |
Add all 10 to your calendar (.ics) → With an account.
Among the 103 studies testing pertuzumab in Breast Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hematological, biochemical and organ dysfunction:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
An initial dose of 840 mg, followed by 420 mg every 3-weeks
A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
75 mg/m2 every 3-weeks
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)
Time frame: 18-20 weeks after first intervention
Total Pathological Complete Response (tpCR)
tpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0)
Time frame: 18-20 weeks after first intervention
Objective Response Rate (ORR)
ORR defined as the proportion of patients who achieved a complete or partial response
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Every 3 weeks (from first intervention to week 18)
| Milestone | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Started | 107 | 107 |
| Completed | 107 | 107 |
| Not completed | 0 | 0 |
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)
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Breast Pathological Complete Response (bpCR) | 71 | 73 |
tpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0)
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Total Pathological Complete Response (tpCR) | 60 | 68 |
ORR defined as the proportion of patients who achieved a complete or partial response
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Complete Response | 64 | 61 |
| Partial Response | 30 | 29 |
| Progressive Disease | 2 | 3 |
| Stable Disease | 3 | 2 |
| Unknown | 8 | 12 |
Rate of BCS for patients for whom mastectomy was planned before treatment (T2-3)
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Lumpectomy | 20 | 21 |
| Mastectomy | 44 | 37 |
| Unknown | 0 | 1 |
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.
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetax |
|---|---|---|
| Safety Assessment Including Treatment Related Adverse Events | 107 | 107 |
Laboratory data including CBC diff have been assessed. All abnormal values were recorded as adverse event.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
The enzyme-linked immunosorbent assay (ELISA) method was used for the assessment of anti-drug antibodies (ADAs).
| Participants | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| Immunogenicity | 0 | 0 |
Collected over 18-20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | 0/107 (0%) | 24/107 (22.4%) | 107/107 (100%) |
| TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | 0/107 (0%) | 15/107 (14%) | 104/107 (97.2%) |
| Event | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| anaemiaBlood and lymphatic system disorders | 14/107 | 10/107 |
| ThrombocytopeniaBlood and lymphatic system disorders | 6/107 | 4/107 |
| VomitingGastrointestinal disorders | 0/107 | 5/107 |
| NauseaGastrointestinal disorders | 4/107 | 0/107 |
| DiarrhoeaGastrointestinal disorders | 3/107 | 0/107 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/107 | 0/107 |
| LeukopeniaBlood and lymphatic system disorders | 2/107 | 0/107 |
| Abdominal painGastrointestinal disorders | 2/107 | 1/107 |
| PyrexiaGeneral disorders | 2/107 | 0/107 |
| Diarrhoea infectiousInfections and infestations | 2/107 | 1/107 |
| Event | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 103/107 | 100/107 |
| NauseaGastrointestinal disorders | 64/107 | 71/107 |
| ThrombocytopeniaBlood and lymphatic system disorders | 68/107 | 69/107 |
| DiarrhoeaGastrointestinal disorders | 60/107 | 67/107 |
| LeukopeniaBlood and lymphatic system disorders | 56/107 | 51/107 |
| VomitingGastrointestinal disorders | 46/107 | 53/107 |
| NeutropeniaBlood and lymphatic system disorders | 49/107 | 47/107 |
| Abdominal painGastrointestinal disorders | 43/107 | 37/107 |
| PainGeneral disorders | 38/107 | 33/107 |
| DyspepsiaGastrointestinal disorders | 37/107 | 31/107 |
| Age, Continuous(years) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Mean | 47.56 ± 10.31 | 44.35 ± 9.81 | 45.95 ± 10.17 |
| Sex: Female, Male(Participants) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Female | 107 | 107 | 214 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 107 | 107 | 214 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/m^2) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Mean | 28.27 ± 5.30 | 27.27 ± 4.38 | 27.77 ± 4.87 |
| BSA(m^2) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Mean | 1.79 ± 0.18 | 1.79 ± 0.18 | 1.79 ± 0.18 |
| IHC2+(Participants) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| FISH+ | 3 | 3 | 6 |
| CISH+ | 6 | 3 | 9 |
| IHC3+(Participants) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Count of participants | 98 | 101 | 199 |
| ER/PR+(Participants) | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and Docetaxel) | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetaxel) | Total |
|---|---|---|---|
| Count of participants | 63 | 64 | 127 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2018 to primary completion in May 2020, 21 months.
Results were first posted in Jul 2024, 4 years 1 month after primary completion.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 21 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pertuzumab
Cinnagen