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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Pathological Complete Response (tpCR) | tpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0) | 18-20 weeks after first intervention |
| Objective Response Rate (ORR) |
Not provided
Inclusion Criteria:
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:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Behrouz Najafi, MD | Assistant Professor of Hematology and Oncology Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Besat Clinic | Rasht | Gilan Province | Iran | |||
| Dr. Behrouz Najafi's office |
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| ID | Title | Description |
|---|---|---|
| FG000 | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and 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; 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 18, 2020 |
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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).
| Pertuzumab | Drug | An initial dose of 840 mg, followed by 420 mg every 3-weeks |
|
| Carboplatin | Drug | A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks |
|
| Docetaxel | Drug | 75 mg/m2 every 3-weeks |
|
ORR defined as the proportion of patients who achieved a complete or partial response
| 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) | 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. | 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. | 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. | 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. | 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). | Every 3 weeks (from first intervention to week 18) |
| Rasht |
| Gilan Province |
| Iran |
| Dr. Mehdi Mirblouk's office | Rasht | Gilan Province | Iran |
| Razi Hospital | Rasht | Gilan Province | Iran |
| Arvand Hospital | Ahvāz | Khozestan | Iran |
| Baqaei Hospital | Ahvāz | Khozestan | Iran |
| Shafa Hospital | Ahvāz | Khozestan | Iran |
| Dr. Aboulqasem Allahyari's office | Mashhad | Razavi Khorasan Province | Iran |
| Imam Reza Hospital | Mashhad | Razavi Khorasan Province | Iran |
| Qaem Hospital | Mashhad | Razavi Khorasan Province | Iran |
| Sanabad Hospital | Mashhad | Razavi Khorasan Province | Iran |
| Milad Hospital | Isfahan | Iran |
| Saba Clinic | Isfahan | Iran |
| Seyed-Al-Shohada Hospital | Isfahan | Iran |
| Sheikh Mofid Clinic | Isfahan | Iran |
| Dr. Behjat Kalantari's office | Kerman | Iran |
| Javad-Al-Aemeh Clinic | Kerman | Iran |
| Shahid Bahonar Hospital | Kerman | Iran |
| Dr. Mehrdad Payende's office | Kermanshah | Iran |
| Amir Hospital | Shiraz | Iran |
| Namazi Hospital | Shiraz | Iran |
| Shahid Faghihi Hospital | Shiraz | Iran |
| Shams Hospital | Tabriz | Iran |
| Baqiatallah Hospital | Tehran | Iran |
| BuoAli Hospital | Tehran | Iran |
| Dr. Safa Najjar Najafi's office | Tehran | Iran |
| Ebn-Sina Hospital | Tehran | Iran |
| Firoozgar Hospital | Tehran | Iran |
| Imam Khomeini Hospital | Tehran | Iran |
| Iran-Mehr Hospital | Tehran | Iran |
| Jam Hospital | Tehran | Iran |
| Jihad University Clinic | Tehran | Iran |
| Masih Daneshvari Hospital | Tehran | Iran |
| Massoud Clinic | Tehran | Iran |
| Mehrad Hospital | Tehran | Iran |
| Naft Hospital | Tehran | Iran |
| Rasool Akram Hospital | Tehran | Iran |
| Resalat Hospital | Tehran | Iran |
| Sajjad Hospital | Tehran | Iran |
| Sina Hospital | Tehran | Iran |
| Taleghani Hospital | Tehran | Iran |
| Tehran Hospital | Tehran | Iran |
| Toos Hospital | Tehran | Iran |
| Dr.Mortazavizadeh's office | Yazd | Iran |
| FG001 | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and 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; 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks |
| BG001 | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| BSA | Mean | Standard Deviation | m^2 |
| |||||||||||||||
| IHC2+ | Count of Participants | Participants |
| ||||||||||||||||
| IHC3+ | Count of Participants | Participants |
| ||||||||||||||||
| ER/PR+ | Count of Participants | Participants |
| ||||||||||||||||
| ER/PR- | Count of Participants | Participants |
| ||||||||||||||||
| Type of breast cancer | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | 18-20 weeks after first intervention |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Pathological Complete Response (tpCR) | tpCR defined as no invasive tumor residues in the breast and lymph nodes (ypT0/is ypN0) | Posted | Count of Participants | Participants | 18-20 weeks after first intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR defined as the proportion of patients who achieved a complete or partial response | Posted | Count of Participants | Participants | 18-20 weeks after first intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Breast-conserving Surgery (BCS) | Rate of BCS for patients for whom mastectomy was planned before treatment (T2-3) | Posted | Count of Participants | Participants | 18-20 weeks after first intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | A total of 214 patients were analyzed for AEs.Reports were based on the Safety set. The safety set included all randomized patients who received at least one dose of the study drug. | Posted | Count of Participants | Participants | Throughout the study duration (from first visit to week 18-20) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Abnormal Laboratory Data | Laboratory data including CBC diff have been assessed. All abnormal values were recorded as adverse event. | Not Posted | Throughout the study duration (from first visit to week 18-20) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | every 6 week (from first visit to week 18-20) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Throughout the study duration (from first visit to week 18-20) | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity | The enzyme-linked immunosorbent assay (ELISA) method was used for the assessment of anti-drug antibodies (ADAs). | A total of 214 patients were analyzed for immunogenicity assessment. | Posted | Count of Participants | Participants | Every 3 weeks (from first intervention to week 18) |
|
18-20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TCHP Regimen (Trastuzumab, Pertuzumab® (CinnaGen Co.), Carboplatin, and 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; 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks | 0 | 107 | 24 | 107 | 107 | 107 |
| EG001 | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-weeks | 0 | 107 | 15 | 107 | 104 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mallory-Weiss syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Decreased appetite | General disorders | Systematic Assessment |
| ||
| Infusion related reaction | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Fatty liver | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hepatomegaly | Hepatobiliary disorders | Systematic Assessment |
| ||
| Diarrhoea infectious | Infections and infestations | Systematic Assessment |
| ||
| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
| ||
| Perirectal abscess | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Microangiopathy | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aphthous ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Decreased appetite | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Flushing | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Xeroderma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Epistaxis | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Nasim Anjidani | Cinnagen Co. | 0989125477964 | anjidani.n@orchidpharmed.com |
| Mar 12, 2023 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2020 | Dec 31, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CISH+ |
|
| Locally advanced |
|
| Operable |
|
|
|
|
|
|
|
|
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| OG001 | TCHP Regimen (Trastuzumab, Perjeta®, Carboplatin, and Docetax | 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. Trastuzumab: An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks Pertuzumab: An initial dose of 840 mg, followed by 420 mg every 3-weeks Carboplatin: A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks Docetaxel: 75 mg/m2 every 3-week |
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