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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CDR0000455631 | 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Giving combination chemotherapy with or without trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.
PURPOSE: This randomized phase II trial is comparing two different regimens of combination chemotherapy given together with or without trastuzumab to see how well they work in treating patients with stage II or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Patients with non HER2/neu overexpressing tumors are randomized to 1 of 2 treatment arms. Patients with HER2/neu overexpressing tumors are assigned to arm III.
Within 4 weeks after completion of chemotherapy with or without trastuzumab (Herceptin®), all patients undergo surgery.
PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | Active Comparator | Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses. |
|
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin | Experimental | Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses. |
|
| Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and trastuzumab | Experimental | Patients receive chemotherapy as in arm II. They also receive trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Patients With Pathologic Complete Response (pCR) | pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes. | At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months |
| Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1. | RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer | At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months. |
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DISEASE CHARACTERISTICS:
Histologically proven infiltrating ductal or lobular breast carcinoma
Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
ECOG performance status < 2
Male or female
Menopausal status not specified (for female patients)
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal (except for patient's with Gilbert's disease)
Creatinine ≤ 1.2 mg/dL
Creatinine clearance ≥ 70 mL/min
Ejection fraction ≥ 50% on MUGA
No neuropathy ≥ grade 1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception
No prior malignant disease within the past 5 years, excluding:
No noninvasive (in situ) breast carcinoma within the past 5 years
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Mortimer, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010-3000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | Patients receive 50mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses. |
| FG001 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2009 |
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| docetaxel | Drug | Given IV |
|
| doxorubicin hydrochloride | Drug | Given IV |
|
| Trastuzumab | Biological | Given IV |
|
| Carboplatin | Drug | Given IV |
|
| Paclitaxel | Drug | Given IV |
|
Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses. |
| FG002 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab | Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses. |
| BG001 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin | Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and 100 mg/m2 paclitaxel repeats every 4 weeks for 3 courses. |
| BG002 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab | Patients receive chemotherapy as in arm II. They also receive 2 mg/kg trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. |
| BG003 | 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 | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Count of Patients With Pathologic Complete Response (pCR) | pCR was defined as no evidence of residual invasive cancer (or very few scattered tumor cells) in primary tumor and lymph nodes. | Posted | Count of Participants | Participants | At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Count of Patients With Residual Cancer Burden (RCB) Scores of 0 or 1. | RCB score is determined using information on the size of the tumor and the extent of tumor cells in the breast and axillary lymph nodes after neoadjuvant therapy. The higher the RCB score, the more residual breast cancer there is in the breast and lymph nodes: RCB-0 = No residual breast cancer RCB-I = Small amount of residual breast cancer RCB-II = Moderate amount of residual breast cancer RCB-III = Extensive (a lot of) residual breast cancer | Posted | Count of Participants | Participants | At the time of surgery within 4 weeks of the end of chemotherapy, up to 10 months. |
|
Adverse events occurred over a period of 2 years and 7 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to 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 | Docetaxel, Doxorubicin Hydrochloride, and Cyclophosphamide | Patients receive 50 mg/m2 doxorubicin hydrochloride IV, 500 mg/m2 cyclophosphamide IV, and 75 mg/m2 docetaxel IV on day 1. Treatment repeats every 21 days for 6 courses. | 2 | 37 | 8 | 37 | 37 | 37 |
| EG001 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel and Carboplatin | Patients receive 60 mg/m2 doxorubicin hydrochloride IV and 600 mg/m2 cyclophosphamide IV on day 1; treatment repeats every 2 weeks for 4 courses. Patients then receive AUC 2 carboplatin IV on day 1 and 100 mg/m2 paclitaxel IV on days 1, 8, and 15; treatment with carboplatin and paclitaxel repeats every 4 weeks for 3 courses. | 4 | 40 | 5 | 40 | 40 | 40 |
| EG002 | Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel, Carboplatin and Trastuzumab | Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. | 4 | 44 | 8 | 44 | 44 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cardiac pain | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nausea | 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 |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Pancreas infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Soft tissue 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 |
| |
| Amylase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum calcium 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 |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra10.0 | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Psychosis | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Lymphatic disorder | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Premature ventricular contractions | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ventricular trigeminy | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | meddra10.0 | Non-systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hearing loss | Ear and labyrinth disorders | meddra10.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cushingoid | Endocrine disorders | meddra10.0 | Non-systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flashing vision | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Watering eyes | 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 |
| |
| 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 | meddra9.0 | Non-systematic Assessment |
| |
| Esophageal pain | 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 |
| |
| Gastrointestinal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhoids | 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 |
| |
| Peritoneal pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Toothache | 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 | meddra9.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Facial pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flu-like symptoms | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| General symptom | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Irritability | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Localized edema | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Immune system disorder | Immune system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Tooth 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 |
| |
| Ureteritis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Intraoperative hepatobiliary injury - Gallbladder | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Intraoperative neurological injury - NERVES: Peripheral sensory NOS | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Wound dehiscence | 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 |
| |
| Amylase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Coagulopathy | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Haptoglobin decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Laboratory test abnormal | 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 |
| |
| Glucose intolerance | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperuricemia | 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 |
| |
| Obesity | Metabolism and nutrition disorders | meddra10.0 | 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 |
| |
| Chest wall 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 |
| |
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra10.0 | Non-systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | meddra10.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neuralgia | 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 | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus pain | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Taste alteration | 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 |
| |
| Euphoria | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Personality change | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage urinary tract | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urine discoloration | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Reproductive tract disorder | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal atresia | Reproductive system and breast disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | meddra10.0 | 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 inflammation | 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 |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | meddra9.0 | 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 |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngeal examination abnormal | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | 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 |
| |
| Atrophy skin | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hand-and-foot syndrome | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain of skin | 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 desquamating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Scalp pain | 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 hypopigmentation | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hematoma | 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 |
| |
| Vascular disorder | Vascular disorders | meddra9.0 | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope | 626-218-5265 | pfrankel@coh.org |
| Mar 31, 2022 |
| Prot_SAP_000.pdf |
| 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 |
|---|---|
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| D000068878 | Trastuzumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| African American |
|
| White |
|
| Hispanic |
|
Patients receive chemotherapy as in arm II. They also receive 2 mg/m2 trastuzumab (Herceptin®) IV weekly, beginning with the first doses of paclitaxel and carboplatin. |
|
|