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| Name | Class |
|---|---|
| Yale University | OTHER |
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Q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable HER2+ (stage IIa-IIIb) breast cancer
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50% in HER2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients. With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pCR rate exceeding 50% for our novel regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neo-adjuvant cohort 1 | Experimental |
| |
| Neo-adjuvant cohort 2 | Experimental |
| |
| Adjuvant cohort 1 | Experimental |
| |
| Adjuvant cohort 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 neo-adjuvant | Drug | Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14 Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC; | These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity | Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment. | 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Sikov, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Yale Smilow Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24885187 | Derived | Cheng H, Bai Y, Sikov W, Sinclair N, Bossuyt V, Abu-Khalaf MM, Harris LN, Rimm DL. Quantitative measurements of HER2 and phospho-HER2 expression: correlation with pathologic response to neoadjuvant chemotherapy and trastuzumab. BMC Cancer. 2014 May 8;14:326. doi: 10.1186/1471-2407-14-326. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14 Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians |
| FG001 | Cohort 2 | Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | |
| BG001 | Cohort 2 | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC; | These numbers represent patients with a RCB score of zero (0). RCB stands for residual cancer burden. | Posted | Number | participants | 1 year |
|
|
Toxicities were captured at start of treatment through 1 year of adjuvant trastuzumab. CTCAE version 3.0 was used.
Please note that all AEs are reported here but this does not mean that all toxicities were deemed related to study treatment.
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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 | Neo-adjuvant Cohort 1 | Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14 Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gr 3port infection, | Investigations | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WBC | Investigations | CTCAE (3.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Sikov, MD | Brown University Oncology Research Group (BrUOG) | 4018633000 | BrUOG@brown.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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|
| Cohort 2 neo-adjuvant | Drug | Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 |
|
| Cohort 1 adjuvant | Drug | Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians |
|
| Cohort 2 adjuvant | Drug | Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians |
|
| New Haven |
| Connecticut |
| 06437 |
| United States |
| Women and Infants Hospital | Providence | Rhode Island | 02903 | United States |
| Roger Williams Medical Center | Providence | Rhode Island | 02908 | United States |
| Rhode Island and The Miriam Hospital | Providence | Rhode Island | 02912 | United States |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity | Please note that these events represent toxicities that were experienced during treatment, but that does not mean that all toxicities were indeed deemed related to study treatment. | Posted | Number | participants | 1 year |
|
|
|
| 7 |
| 37 |
| 37 |
| 37 |
| EG001 | Neo-adjuvant Cohort 2 | Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16 | 8 | 23 | 23 | 23 |
| EG002 | Adjuvant Cohort 1 | Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians | 5 | 29 | 29 | 29 |
| EG003 | Adjuvant Cohort 2 | Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians | 3 | 19 | 19 | 19 |
| flu | Investigations | CTCAE (3.0) |
|
| Febrile Neutropenia | Investigations | CTCAE (3.0) |
|
| gr 4 sepsis, intubated | Investigations | CTCAE (3.0) | neutro 3, anemia 3, thromb 4, HTN 4, arf 3, hypok 4, hypocal 4, ards 4, hyperbili 3, tach 4, fever 2 |
|
| Diarrhea gr 2, Nausea gr 3, infection gr 3 | Investigations | CTCAE (3.0) |
|
| infection normal ANC/viral grade 1 | Investigations | CTCAE (3.0) |
|
| Dehydration 3, Diarrhea 3, Vomit 3, HGB3, Nausea 3, K 3, Dyspnea 2 | Investigations | CTCAE (3.0) |
|
| gr 3cellulitis - breast | Investigations | CTCAE (3.0) |
|
| gr 3 diarrhea, gr 2 neutropenia | Investigations | CTCAE (3.0) |
|
| UTI, gr 3 ANC, gr 3 HGB, Gr3 infection, Gr 2 fever and pain, gr1 rigor | Investigations | CTCAE (3.0) |
|
| Dehydration | Investigations | CTCAE (3.0) |
|
| fever unknown etiology gr 1, lymphatics gr 1 | Investigations | CTCAE (3.0) |
|
| Syncopal epidose gr 3, dehydration gr 2, diabetes gr 2, anemia gr 2 | Investigations | CTCAE (3.0) |
|
| thrombus occlusive L IJ gr 3, hypomagnesia gr 1, hypokalemia gr 1 | Investigations | CTCAE (3.0) |
|
| dehydr gr3, chest pain gr 3, | Investigations | CTCAE (3.0) | Hypotension gr 2, HGB gr 3, Fever gr2, creatinine gr 1, diarrhea gr 2, infection gr 3, ANC gr 3, |
|
| gr 3 left jugular thrombis , anemia gr 2, | Investigations | CTCAE (3.0) |
|
| left ear otitis externa gr 3, ANC 4, WBC 2 Diarrhea 1 | Investigations | CTCAE (3.0) |
|
| vomit gr 3, Nausea gr 3, diarrhea gr2, GI bleed gr 2, Abdominal pain rg3, | Investigations | CTCAE (3.0) | hgb gr 2, Na 1, K 1, Ca 1, ANC 2, Anorexia 3,dehydration gr3, cr gr 1, WBC gr 2, |
|
| vomiting gr 3, infection Cdiff gr 3, Hypokalemia gr 1, gr 1 hypomagnesia | Investigations | CTCAE (3.0) |
|
| right upper extremity cellulitis gr 3, | Investigations | CTCAE (3.0) | right ue pain gr 2, UTI gr 2, WBC gr 2, HGB gr 2, ANC gr 2, K gr 2, hypoalbum gr 1, INR gr 1, constipation gr 1, |
|
| gr 3 ulcerative colitis exacerbation with and without gr 1 fever) | Investigations | CTCAE (3.0) |
|
| gran mal seizure-2 | Investigations | CTCAE (3.0) |
|
| allergic rxn | Investigations | CTCAE (3.0) |
|
| Febrile neutropenia gr 2, Anemia 2, ANC 4, | Investigations | CTCAE (3.0) | External ear inflammation 1, tachycardia 1, PLT 1, Myalgias 2 |
|
| suicidal ideation gr 2 and depression gr 3 not related | Investigations | CTCAE (3.0) |
|
| post re-construction pt experienced seroma grade 2 | Investigations | CTCAE (3.0) |
|
| hernia grade 3 secondary to surgery healing issue | Investigations | CTCAE (3.0) |
|
| Sepsis 3, PLT 1, K, 1, Ca, 1, Hgb1, Phos, 3, Pruritis, 1 | Investigations | CTCAE (3.0) |
|
| cardiac ischemia gr 2, | Investigations | CTCAE (3.0) |
|
| gr 3 abd pain, gr 1 nausea, gr 2 vomitting | Investigations | CTCAE (3.0) |
|
| impt medical event(gr2) abnormal stress test need for cardiac cath | Investigations | CTCAE (3.0) |
|
| ANC | Investigations | CTCAE (3.0) |
|
| plt | Investigations | CTCAE (3.0) |
|
| HGB | Investigations | CTCAE (3.0) |
|
| M/A | Investigations | CTCAE (3.0) |
|
| creatinine | Investigations | CTCAE (3.0) |
|
| Anorexia | Investigations | CTCAE (3.0) |
|
| wt loss | Investigations | CTCAE (3.0) |
|
| Fatigue | Investigations | CTCAE (3.0) |
|
| Rash | Investigations | CTCAE (3.0) |
|
| nausea | Investigations | CTCAE (3.0) |
|
| vomiting | Investigations | CTCAE (3.0) |
|
| mucositis | Investigations | CTCAE (3.0) |
|
| diarrhea | Investigations | CTCAE (3.0) |
|
| rhinitis | Investigations | CTCAE (3.0) |
|
| AST/ALT | Investigations | CTCAE (3.0) |
|
| Neurosensory | Investigations | CTCAE (3.0) |
|
| Neuromuscular | Investigations | CTCAE (3.0) |
|
| Investigations | CTCAE (3.0) |
|
| K | Investigations | CTCAE (3.0) |
|
| Mg | Investigations | CTCAE (3.0) |
|
| Ca | Investigations | CTCAE (3.0) |
|
| Phos | Investigations | CTCAE (3.0) |
|
| Infection | Investigations | CTCAE (3.0) |
|
| HTN | Investigations | CTCAE (3.0) |
|
| Abd pain | Investigations | CTCAE (3.0) |
|
| tinnuitius | Investigations | CTCAE (3.0) |
|
| cough | Investigations | CTCAE (3.0) |
|
| chest pain | Investigations | CTCAE (3.0) |
|
| epistaxis | Investigations | CTCAE (3.0) |
|
| pulmonary embolism | Investigations | CTCAE (3.0) |
|
| wt gain | Investigations | CTCAE (3.0) |
|
| ocular | Investigations | CTCAE (3.0) |
|
| rectal bleed | Investigations | CTCAE (3.0) |
|
| insomnia | Investigations | CTCAE (3.0) |
|
| glucose | Investigations | CTCAE (3.0) |
|
| dyspnea | Investigations | CTCAE (3.0) |
|
| alopecia | Investigations | CTCAE (3.0) |
|
| heartburn | Investigations | CTCAE (3.0) |
|
| rigors | Investigations | CTCAE (3.0) |
|
| edema | Investigations | CTCAE (3.0) |
|
| dizziness | Investigations | CTCAE (3.0) |
|
| headache | Investigations | CTCAE (3.0) |
|
| troponin | Investigations | CTCAE (3.0) |
|
| tachycardia | Investigations | CTCAE (3.0) |
|
| hyperpigmentation | Investigations | CTCAE (3.0) |
|
| proteinuria | Investigations | CTCAE (3.0) |
|
| SOB | Investigations | CTCAE (3.0) |
|
| desquam skin | Investigations | CTCAE (3.0) |
|
| back pain | Investigations | CTCAE (3.0) |
|
| glucose | Investigations | CTCAE (3.0) |
|
| DVT | Investigations | CTCAE (3.0) |
|
| pain breast | Investigations | CTCAE (3.0) |
|
| mood alteration | Investigations | CTCAE (3.0) |
|
| chelitis | Investigations | CTCAE (3.0) |
|
| albumin | Investigations | CTCAE (3.0) |
|
| hypouricemia | Investigations | CTCAE (3.0) |
|
| Lymphopenia | Investigations | CTCAE (3.0) |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |