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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00671 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000631625 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with carboplatin, trastuzumab, and lapatinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving docetaxel together with carboplatin, trastuzumab, and lapatinib in treating patients with early stage breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity..
After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| docetaxel + carboplatin + trastuzumab + lapatinib | Experimental | Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological |
| ||
| carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0 | Up to 10 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive adenocarcinoma of the breast fulfilling the following criteria:
Nonmetastatic disease
Operable and adequately excised
Node-positive OR -negative and determined eligible to receive adjuvant trastuzumab (Herceptin®)
No positive or suspicious internal mammary nodes by SNS that have not been or will not be irradiated
No supraclavicular lymph node involvement (confirmed by fine needle aspiration or biopsy)
Over expression and/or amplification of HER2 in the invasive component of the primary tumor, according to one of the following:
3+ over-expression by IHC (> 30% of invasive tumor cells)
2+ or 3+ (in 30% or less neoplastic cells) over-expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification
HER2 gene amplification by FISH/CISH (> 6 HER2 gene copies per nucleus, or a FISH ratio [HER2 gene copies to chromosome 17 signals] of > 2.2.)
Hormone receptor status known (estrogen receptor with or without progesterone receptor)
PATIENT CHARACTERISTICS:
Menopausal status not specified
ECOG performance status 0-1
Hemoglobin ≥ 10.0 g/dL
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Serum creatinine ≤ 2.0 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN
Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if known Gilbert syndrome)
Baseline LVEF ≥ 50% measured by ECHO or MUGA scan
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No serious cardiac illness or medical condition including, but not limited to, any of the following:
No other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions or illness
None of the following:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Edith A. Perez, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Front Range Cancer Specialists |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| docetaxel | Drug |
|
| lapatinib ditosylate | Drug |
|
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | 61265 | United States |
| Moline | Illinois | 61265 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States |
| Howard Community Hospital | Kokomo | Indiana | 46904 | United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Saint Joseph Regional Medical Center | South Bend | Indiana | 46617 | United States |
| South Bend Clinic | South Bend | Indiana | 46617 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| Bettendorf | Iowa | 52722 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | 50325 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Hospital District Sixth of Harper County | Anthony | Kansas | 67003 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| Northern Montana Hospital | Havre | Montana | 59501 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Cancer Resource Center - Lincoln | Lincoln | Nebraska | 68510 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131-5636 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| North Coast Cancer Care - Clyde | Clyde | Ohio | 43410 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Hematology Oncology Center | Elyria | Ohio | 44035 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Wayne Hospital | Greenville | Ohio | 45331 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537-1839 | United States |
| St. Luke's Hospital | Maumee | Ohio | 43537 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| St. Anne Mercy Hospital | Toledo | Ohio | 43623 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Clinton Memorial Hospital | Wilmington | Ohio | 45177 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Proportion of Patients Experiencing Grade 3 or 4 Diarrhea as Measured by NCI CTCAE v3.0 | All evaulable patients | Posted | Number | percentage of patients | Up to 10 years |
|
|
|
Not provided
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 | Group 1 | Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years. | 10 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12 | Systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Taste alteration | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pharyngeal mucositis | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 12 | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Moreno-Aspitia, M.D. | Mayo Clinic | (904) 953-7291 | morenoaspitia.alvaro@mayo.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000077341 | Lapatinib |
| 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 |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|