S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00041067
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* Determine the 1-year survival of women with HER2-positive stage IV breast cancer treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim (G-CSF) support.
* Determine the response rate (complete and partial, confirmed and unconfirmed) in the subset of patients with measurable disease treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the qualitative and quantitative toxic effects of this regimen in these patients.
* Obtain tissue blocks for the determination of predictors of response (e.g., beta-tubulin mutations) to microtubule interacting agents in this patient population and for other future studies.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab, docetaxel, vinorelbine and filgrastim filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim trastuzumab Trastuzumab, docetaxel, vinorelbine and filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim docetaxel Trastuzumab, docetaxel, vinorelbine and filgrastim Trastuzumab, docetaxel, vinorelbine and filgrastim vinorelbine Trastuzumab, docetaxel, vinorelbine and filgrastim
- Primary Outcome Measures
Name Time Method Survival at 1 Year 1 year
- Secondary Outcome Measures
Name Time Method Response Rate (Complete and Partial, Confirmed and Unconfirmed) response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession 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.
Progression-free Survival 2 years Toxicity toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession 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.
Trial Locations
- Locations (145)
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Sletten Regional Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
University Hospital - San Antonio
🇺🇸San Antonio, Texas, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Providence Centralia Hospital Regional Cancer Center
🇺🇸Centralia, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center
🇺🇸Jonesboro, Arkansas, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
🇺🇸Pensacola, Florida, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Hematology Oncology Consultants - Naperville
🇺🇸Naperville, Illinois, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Valley Hospital - Ridgewood
🇺🇸Ridgewood, New Jersey, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Gape Girardeau, Missouri, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
🇺🇸Kearney, Nebraska, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
MedCentral - Mansfield Hospital
🇺🇸Mansfield, Ohio, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Community Oncology Group at Cleveland Clinic Cancer Center
🇺🇸Independence, Ohio, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
AnMed Health Cancer Center
🇺🇸Anderson, South Carolina, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Bay Regional Medical Center
🇺🇸Bay City, Michigan, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Highland General Hospital at St. George's University School of Medicine
🇺🇸Oakland, California, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
🇺🇸Ft. Smith, Arkansas, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Edward Hospital Cancer Center
🇺🇸Naperville, Illinois, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Stormont-Vail Cancer Center
🇺🇸Topeka, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Auburn Regional Center for Cancer Care
🇺🇸Auburn, Washington, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Capital Medical Center
🇺🇸Olympia, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Wooley, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
St. Joseph Medical Center at Franciscan Health System
🇺🇸Tacoma, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Hematology Oncology Associates, PC
🇺🇸Albuquerque, New Mexico, United States
Lovelace Medical Center
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Ted B. Wahby Cancer Center at Mount Clemens General Hospital
🇺🇸Mount Clemens, Michigan, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States