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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CDR0000442105 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy 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. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.
OBJECTIVES:
OUTLINE: Patients undergo stem cell collection.
After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. |
|
| Arm II | Experimental | Patients undergo stem cell collection. Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trastuzumab | Biological | Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-Year Relapse-free Survival Rate | Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically. | From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment |
| 5-Year Overall Survival Rate | Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up | From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment. |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
Stage IIIB or IIIC disease, meeting both of the following criteria:
Stage IV disease, meeting all of the following criteria:
Inflammatory breast cancer allowed
Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| George Somlo, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| carboplatin | Drug | Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion |
|
| cyclophosphamide | Drug | Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion |
|
| melphalan | Drug | Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion |
|
| thiotepa | Drug | Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion |
|
| adjuvant therapy | Procedure | Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy. |
|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation. |
|
| bone marrow ablation with stem cell support | Procedure | Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation |
|
| radiation therapy | Radiation | After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. |
| 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 |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | 5-Year Relapse-free Survival Rate | Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. Whenever possible, relapses should be documented histologically. | Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis. | Posted | Median | 95% Confidence Interval | percentage of participants | From time of initial PBPC rescue until death or disease recurrence (disease progression for patients with stage IV disease), whichever came first, up to 5 years post treatment |
|
|
| |||||||||||||||||||||||||
| Primary | 5-Year Overall Survival Rate | Estimated using the product-limit method of Kaplan and Meier. Patients who were still alive were censored at the date of last follow-up | Patients from this study were combined with patients from a follow-up study in which 27 patients from this study met the eligibility requirements for meta-analysis. | Posted | Median | 95% Confidence Interval | percentage of participants | From time of initial PBPC rescue until the date of death from any cause, assessed up to 5 years post treatment. |
|
|
Adverse events took place over a period of 4 years, 3 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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 | All Patients | Patients undergo stem cell collection. Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®), one day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation, no more than 7 weeks later, patients proceed to course 2; OR Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation. After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. | 24 | 32 | 30 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | meddra10.0 | Non-systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Prolonged intubation after pulmonary resection (>24 hrs after surgery) | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Premature ventricular contractions | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | meddra10.0 | Non-systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Intra-abdominal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rectal mucositis | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Gingival infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Opportunistic infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Upper aerodigestive tract infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Intraoperative gastrointestinal injury - Teeth | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Coagulopathy | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Hypercholesterolemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| INR increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Serum cholesterol increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood uric acid increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus pain | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | meddra9.0 | Non-systematic Assessment |
| |
| Psychosis | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal hemorrhage | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal pain | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hiccough | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Telangiectasia | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhage | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-359-8111 | 65265 | pfrankel@coh.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D008558 | Melphalan |
| D013852 | Thiotepa |
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| 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 |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided
|