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Data Safety Monitoring Board is in agreement with the study findings so far and the stopping rule has been met, which suspends the study treatment arms in March 2021.
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Primary Objective:
• Determination of pathologic complete response (pCR) rates
Secondary Objective:
Study Design
Approximately 34-74 patients with Her2 positive, Stage II-regional IV breast cancer will be enrolled.
Patients will be stratified by ER/PR status.
They will be randomized to ddACTHP vs TCHP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ddACTHP | Active Comparator | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year |
|
| TCHP | Active Comparator | TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel 75mg/m2 IV, day 1 |
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Pathologic Complete Response (pCR) | Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cardiac Toxicity Events | Determination of cardiac toxicity as measured by LVEF, longitudinal strain and troponin. Left ventricular ejection fraction (LVEF) measurement of amount of blood being pumped out of the left ventricle of the heart with each contraction. Peak systolic longitudinal strain is calculated by averaging the values of peak systolic strain in the basal, mid and apical segments of the LV in 4-, 3- and 2-chamber views on echocardiograms. A value of <-18% or a >15% decline in strain from patient's baseline value will be used as a cut-off value. A value of troponin I > 0.08 ng/ml will be considered elevated. |
Not provided
Inclusion Criteria:
The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
Female
18 years or older
ECOG performance status of 0 or 1
Eligible tumors must meet one of the following criteria:
Staging evaluation:
Diagnosis of invasive adenocarcinoma made by core needle biopsy
Breast cancer determined to be:
Confirmed HER2-positive : (ASCO CAP guidelines, 10/7/2013)
any ER or PR receptor status
LVEF assessment by echocardiogram within 30 days of initiation; EF of ≥ 55% considered normal.
Normal troponin I level at baseline
Blood counts must meet the following criteria:
Serum creatinine less than or equal 2.5 mg/100ml
Adequate hepatic function by these criteria: total bilirubin must be less than or equal to 1.5 x the ULN for the lab unless the patient has a bilirubin elevation great than the ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST must be less than or equal to 1.5 x ULN for the lab. Both alkaline phosphatase and AST may not both be greater than the ULN.
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET-CT or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements are met as above
Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease.
Exclusion Criteria:
Patients with a history of decompensated congestive heart failure or an EF < 55% will be excluded
• Cardiac disease that would preclude the use of the drugs included in the above regimens. This includes but is not confined to:
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| Name | Affiliation | Role |
|---|---|---|
| Aarti Bhardwaj, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Beth Israel | New York | New York | 10011 | United States | ||
| Mount Sinai West |
Not provided
Not provided
Not provided
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | ddACTHP | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Doxorubicin: Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1 Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Drug |
Carboplatin AUC 6 IV, day 1 |
|
| Trastuzumab | Drug | Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1 |
|
| Pertuzumab | Drug | Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 |
|
| Pegfilgrastim | Drug | Pegfilgrastim 6mg SC, day 2 Cycled as per arm |
|
| Trastuzumab | Drug | Trastuzumab 6mg/kg every 21 days to complete 1 year |
|
| Paclitaxel | Drug | Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. |
|
| Doxorubicin | Drug | Doxorubicin 60 mg/m2 IV day 1 |
|
| Cyclophosphamide | Drug | Cyclophosphamide 600 mg/m2 IV day 1 |
|
| Paclitaxel | Drug | 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 |
|
| 2 years |
| Number of Non-cardiac Toxicities | The frequency of adverse events categorized using CTCAE v4.03 | 2 years |
| Number of Participants With Breast Conservation | Number of participants with breast-conserving surgery for patients for whom mastectomy was planned before treatment. It would be based on surgical opinion at time of surgery if the tumor was appropriately "downstaged" to perform breast conserving surgery on patients previously recommended to have a mastectomy. | 2 years |
| Number of Participants Alive at the End of the Study | Overall Survival - Number of participants alive at the end of the study. | 2 years |
| New York |
| New York |
| 10019 |
| United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| FG001 | TCHP | TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Docetaxel: Docetaxel 75mg/m2 IV, day 1 Carboplatin: Carboplatin AUC 6 IV, day 1 Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1 Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ddACTHP | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Doxorubicin: Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1 Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 |
| BG001 | TCHP | TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Docetaxel: Docetaxel 75mg/m2 IV, day 1 Carboplatin: Carboplatin AUC 6 IV, day 1 Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1 Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants With Pathologic Complete Response (pCR) | Pathologic complete response (pCR) defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of neoadjuvant systemic therapy. | Posted | Count of Participants | Participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Cardiac Toxicity Events | Determination of cardiac toxicity as measured by LVEF, longitudinal strain and troponin. Left ventricular ejection fraction (LVEF) measurement of amount of blood being pumped out of the left ventricle of the heart with each contraction. Peak systolic longitudinal strain is calculated by averaging the values of peak systolic strain in the basal, mid and apical segments of the LV in 4-, 3- and 2-chamber views on echocardiograms. A value of <-18% or a >15% decline in strain from patient's baseline value will be used as a cut-off value. A value of troponin I > 0.08 ng/ml will be considered elevated. | Posted | Number | events | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Non-cardiac Toxicities | The frequency of adverse events categorized using CTCAE v4.03 | Posted | Number | events | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Breast Conservation | Number of participants with breast-conserving surgery for patients for whom mastectomy was planned before treatment. It would be based on surgical opinion at time of surgery if the tumor was appropriately "downstaged" to perform breast conserving surgery on patients previously recommended to have a mastectomy. | Posted | Count of Participants | Participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Alive at the End of the Study | Overall Survival - Number of participants alive at the end of the study. | Posted | Count of Participants | Participants | 2 years |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ddACTHP | Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Pegfilgrastim 6mg SC, day 2 of AC Cycled every 14 days for 4 cycles, followed by, Paclitaxel 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 Trastuzumab 8 mg/kg IV day 1, followed by 6mg/kg Pertuzumab loading dose 840 mg IV followed by 420 mg IV every 3 weeks Cycled every 21 days for 4 cycles, followed by, Trastuzumab 6mg/kg every 21 days to complete 1 year Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Doxorubicin: Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide: Cyclophosphamide 600 mg/m2 IV day 1 Paclitaxel: 80 mg/m2 IV x 1 hour infusion on days 1, 8, and 15 | 0 | 2 | 0 | 2 | 2 | 2 |
| EG001 | TCHP | TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Docetaxel: Docetaxel 75mg/m2 IV, day 1 Carboplatin: Carboplatin AUC 6 IV, day 1 Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1 Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. | 0 | 5 | 0 | 5 | 5 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| ALT increase | Hepatobiliary disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| ANC decrease | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| AST increase | Hepatobiliary disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (unspecified) | Non-systematic Assessment |
| |
| chest pain | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| cardiac Troponin-I increase | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dizziness | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dry eyes | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dry mouth | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dysgeusia | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| edema- limb | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Ejection fraction decrease | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| edema-facial | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| fatigue | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| fever | General disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Gatro-esophageal reflux disease | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| hot flashes | Vascular disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Lymphocyte count decrease | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Parathesia | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Platelet count decrease | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders other, cysts on groin/pelvis area | Skin and subcutaneous tissue disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Thromboembolic event | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| WBC decrease | Blood and lymphatic system disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Watering of eyes | Eye disorders | CTCAE (unspecified) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aarti Bhardwaj | Icahn School of Medicine at Mount Sinai | (212) 824-8578 | Aarti.Bhardwaj@mountsinai.org |
| May 30, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2021 | May 30, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| C455861 | pegfilgrastim |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| 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 |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| TCHP |
TCHP (Docetaxel, Carboplatin, Trastuzumab, Pertuzumab, Pegfilgrastim ) institutional practice is to titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. Docetaxel: Docetaxel 75mg/m2 IV, day 1 Carboplatin: Carboplatin AUC 6 IV, day 1 Trastuzumab: Trastuzumab 8mg/kg IV initial dose, followed by 6mg/kg IV , day 1 Pertuzumab: Pertuzumab 840 mg IV initial dose followed by 420 mg IV, day 1 Pegfilgrastim: Pegfilgrastim 6mg SC, day 2 Cycled as per arm Trastuzumab: Trastuzumab 6mg/kg every 21 days to complete 1 year Paclitaxel: Titrate the infusion rate on the initial Paclitaxel dose (40 ml/hr x 5 min, then 80 ml/hr x 5 min, then 120 ml/hr x 10 min, then 200 ml/hr). Subsequent Paclitaxel doses are given over 1 hour. |
|
|
|
|
|
|
|
|