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| ID | Type | Description | Link |
|---|---|---|---|
| S0215 | Other Identifier | SWOG | |
| U10CA032102 | U.S. NIH Grant/Contract | View source |
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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 tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy with G-CSF support.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab, docetaxel, vinorelbine and filgrastim | Experimental | Trastuzumab, docetaxel, vinorelbine and filgrastim |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
| ||
| trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at 1 Year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points. | response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer
HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting
No effusions or ascites as only sites of disease
No primary or metastatic brain or central nervous system tumor
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph J. Kash, MD | Edward Hospital Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21826527 | Result | Livingston RB, Barlow WE, Kash JJ, Albain KS, Gralow JR, Lew DL, Flaherty LE, Royce ME, Hortobagyi GN. SWOG S0215: a phase II study of docetaxel and vinorelbine plus filgrastim with weekly trastuzumab for HER2-positive, stage IV breast cancer. Breast Cancer Res Treat. 2011 Nov;130(1):123-31. doi: 10.1007/s10549-011-1698-5. Epub 2011 Aug 9. |
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During the period February 2003 to December 2006, 76 patients were enrolled at 28 SWOG institutions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab, Docetaxel, Vinorelbine and Filgrastim | Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
|
| docetaxel | Drug |
|
| vinorelbine | Drug |
|
| Progression-free Survival | 2 years |
| Toxicity | Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported. | toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession |
| Fort Smith |
| Arkansas |
| 72903 |
| United States |
| Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center | Jonesboro | Arkansas | 72401-9320 | United States |
| Eden Medical Center | Castro Valley | California | 94546 | United States |
| Saint Rose Hospital | Hayward | California | 94545 | United States |
| Highland General Hospital at St. George's University School of Medicine | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Valley Care Medical Center | Pleasanton | California | 94588 | United States |
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
| Mercy General Hospital | Sacramento | California | 95819 | United States |
| Doctors Medical Center - San Pablo Campus | San Pablo | California | 94806 | United States |
| West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola | Florida | 32514 | United States |
| St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho | 83712 | United States |
| Saint Anthony's Hospital at Saint Anthony's Health Center | Alton | Illinois | 62002 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Good Samaritan Regional Health Center | Mount Vernon | Illinois | 62864 | United States |
| Edward Hospital Cancer Center | Naperville | Illinois | 60540 | United States |
| Hematology Oncology Consultants - Naperville | Naperville | Illinois | 60540 | 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, PA - Kingman | Kingman | Kansas | 67068 | 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 |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Stormont-Vail Cancer Center | Topeka | Kansas | 66604 | United States |
| St. Francis Comprehensive Cancer Center | Topeka | Kansas | 66606 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | 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 |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Bay Regional Medical Center | Bay City | Michigan | 48708 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens | Michigan | 48043 | United States |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | 48060 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63701 | United States |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau | Missouri | 63701 | 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 - St. Louis-Cape Girardeau | St Louis | Missouri | 63141 | United States |
| David C. Pratt Cancer Center at St. John's Mercy | St Louis | Missouri | 63141 | 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 | Billings | Montana | 59101 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59107-5100 | United States |
| Deaconess Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| St. James Community Hospital | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405 | United States |
| Great Falls Clinic | Great Falls | Montana | 59405 | United States |
| Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology | 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 |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska | 68848-1990 | United States |
| Valley Hospital - Ridgewood | Ridgewood | New Jersey | 07450 | United States |
| Hematology Oncology Associates, PC | Albuquerque | New Mexico | 87106 | United States |
| Lovelace Medical Center | Albuquerque | New Mexico | 87108 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| New Mexico Cancer Care Associates | Santa Fe | New Mexico | 87505 | United States |
| Highland Hospital of Rochester | Rochester | New York | 14620 | United States |
| Interlakes Oncology/Hematology PC | Rochester | New York | 14623 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Community Oncology Group at Cleveland Clinic Cancer Center | Independence | Ohio | 44131 | United States |
| MedCentral - Mansfield Hospital | Mansfield | Ohio | 44903 | United States |
| Cleveland Clinic - Wooster | Wooster | Ohio | 44691 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland | Oregon | 97210 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Bon Secours St. Francis Health System | Greenville | South Carolina | 29601 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0361 | United States |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | 78209 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229-3900 | United States |
| Cancer Therapy and Research Center | San Antonio | Texas | 78229 | United States |
| University Hospital - San Antonio | San Antonio | Texas | 78229 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Latter Day Saints Hospital | Salt Lake City | Utah | 84103 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Auburn Regional Center for Cancer Care | Auburn | Washington | 98002 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Providence Centralia Hospital Regional Cancer Center | Centralia | Washington | 98531-9027 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Skagit Valley Hospital Cancer Care Center | Mount Vernon | Washington | 98273 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506-5166 | United States |
| Capital Medical Center | Olympia | Washington | 98507 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Polyclinic First Hill | Seattle | Washington | 98122 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| North Puget Oncology at United General Hospital | Sedro-Woolley | Washington | 98284 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| St. Joseph Medical Center at Franciscan Health System | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| Eligible |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab, Docetaxel, Vinorelbine and Filgrastim | Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles vinorelbine : 27.5 mg/m^2 on Days 8 and 15 filgrastim : 5 microg/kg/day on Days 2 to 21 trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | 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 | Survival at 1 Year | All eligible patients | Posted | Number | 95% Confidence Interval | percentage of patients | 1 year |
|
|
| ||||||||||||||||||||||||||
| Secondary | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points. | patients with Response Evaluation Criteria in Solid Tumors measurable disease | Posted | Number | participants | response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | All eligible patients | Posted | Median | 95% Confidence Interval | months | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Toxicity | Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported. | Eligible patients | Posted | Number | Participants | toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession |
|
|
Every 3 weeks for up to 3 years.
Of the 74 eligible patients analyzed, one patient did not have toxicity assessments performed so only 73 patients are included in the adverse event evaluation.
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 | Docetaxel + Vinorelbine + G-CSF + Trastuzumab | 0 | 73 | 71 | 73 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| LVEF decrease/CHF | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye-other | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tearing | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal pain/cramping | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation/bowel obstruction | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea without colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia/heartburn | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue/malaise/lethargy | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/o 3-4 neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia/granulocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT (AST) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT (ALT) increase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Chest pain,not cardio or pleur | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Muscle weakness (not neuro) | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/light headedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neuropathic pain | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety/agitation | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pneumonitis/infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study statistician | SWOG | 206-667-4623 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| 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 |
|---|---|
| D000069585 | Filgrastim |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Title | Measurements |
|---|
|
| 60-69 |
|
| 70-79 |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Alkaline phosphatase increase |
| |||||
| Anemia |
| |||||
| Arthralgia |
| |||||
| Bone pain |
| |||||
| Catheter related infection |
| |||||
| Chest pain,not cardio or pleur |
| |||||
| Dehydration |
| |||||
| Depression |
| |||||
| Diarrhea without colostomy |
| |||||
| Dyspepsia/heartburn |
| |||||
| Dyspnea |
| |||||
| Fatigue/malaise/lethargy |
| |||||
| Febrile neutropenia |
| |||||
| Headache |
| |||||
| Hyperglycemia |
| |||||
| Hypermagnesemia |
| |||||
| Hypokalemia |
| |||||
| Hypophosphatemia |
| |||||
| Hypotension |
| |||||
| Hypoxia |
| |||||
| Infection w/o 3-4 neutropenia |
| |||||
| Infection with 3-4 neutropenia |
| |||||
| LVEF decrease/CHF |
| |||||
| Leukopenia |
| |||||
| Lymphopenia |
| |||||
| Muscle weakness (not neuro) |
| |||||
| Nausea |
| |||||
| Neutropenia/granulocytopenia |
| |||||
| PRBC transfusion |
| |||||
| Pain-other |
| |||||
| Pericar. effusion/pericarditis |
| |||||
| Pneumonitis/infiltrates |
| |||||
| Respiratory infect w/ neutrop |
| |||||
| Respiratory infection, unk ANC |
| |||||
| SGPT (ALT) increase |
| |||||
| Sensory neuropathy |
| |||||
| Syncope |
| |||||
| Tearing |
| |||||
| Thrombosis/embolism |
| |||||
| Transplant-pRBC transfusion |
| |||||
| Vomiting |
|