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Home > "P" Clinical Trials Conditions > Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer  Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer,stage 3B breast cancer
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use 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. It is not yet known which of two regimens of paclitaxel, with or without trastuzumab, is more effective in treating women with inoperable, recurrent, or metastatic breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of paclitaxel, with or without trastuzumab, in treating women who have breast cancer that is inoperable, recurrent, or metastatic, with or without overexpression of HER2/neu.
Details: OBJECTIVES: - Compare the response rate in patients with inoperable, recurrent, or metastatic breast cancer treated with paclitaxel via one hour infusion every week vs 3 hour infusion every 3 weeks, regardless of HER2-Neu status and assignment to trastuzumab. - Compare the response rate and quality of life in patients with HER2-Neu non-overexpressing disease treated with 1 of these 2 paclitaxel regimens with or without trastuzumab. - Correlate amplification and overexpression of the growth factor receptor ErbB2 by immunohistochemistry and fluorescent in situ hybridization (FISH) with response rate, time to progression, and overall survival in patients treated with 1 of these 2 paclitaxel regimens with or without trastuzumab. - Correlate ErbB2 shed extracellular domain (ECD) with response rate, time to progression, and overall survival in patients treated with 1 of these 2 paclitaxel regimens with or without trastuzumab. - Assess the patterns of ErbB2/ECD after treatment and upon relapse. - Compare the time to progression and survival of patients with HER2-Neu overexpressing disease treated with 1 of these 2 paclitaxel regimens with trastuzumab. - Compare the time to progression and survival in patients with HER2-Neu nonoverexpressing disease treated with 1 of these 2 paclitaxel regimens with or without trastuzumab. - Compare the cardiac toxicity of these regimens as measured by changes in left ventricular ejection fraction from baseline to follow up measurements in these patients. OUTLINE: This is a randomized study. Patients are stratified according to prior chemotherapy for metastatic disease (none or recurrence more than 6 months after adjuvant therapy vs one or none but recurrence less than 6 months after adjuvant therapy) and HER2-Neu overexpression (yes vs no). Patients are assigned to 1 of 2 treatment groups based on HER2-Neu status: - Patients are randomized to 1 of 4 treatment arms: - Arm I: Patients receive paclitaxel IV over 3 hours on day 1. - Arm II: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. - Arm III: Patients receive paclitaxel as in arm I. Patients receive an initial loading dose of trastuzumab (Herceptin) IV over 90 minutes on day 1 of course 1, and maintenance dose of trastuzumab IV over 30 minutes on day 1 of subsequent courses and days 8 and 15 of all courses. Trastuzumab is administered immediately after completion of paclitaxel infusion on weeks of concurrent administration. - Arm IV: Patients receive paclitaxel as in arm II and trastuzumab as in arm III. - Arm V: Patients receive treatment as in arm III. - Arm VI: Patients receive treatment as in arm IV. - Group B: (HER2-Neu overexpressing): Patients are randomized to 1 of 2 treatment arms: - Both groups: Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 3, 6, and 9 months. Patients are followed at 6, 12, and 18 months, and then annually for 5 years or until death. PROJECTED ACCRUAL: A total of 580 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven inoperable, recurrent, or metastatic adenocarcinoma of the breast - Known HER2-Neu status - Measurable disease - No CNS metastases unless at least 6 months since cranial radiotherapy and the patient is asymptomatic and not receiving corticosteroids for this condition at time of enrollment - No leptomeningeal carcinoma (carcinomatous meningitis) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm3 - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin normal - SGOT no greater than 3 times upper limit of normal (ULN) Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Left ventricular ejection fraction at least 45% Other: - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior trastuzumab - Concurrent epoetin alfa allowed Chemotherapy: - No more than 1 prior chemotherapy regimen for locally advanced or metastatic breast cancer - No prior taxane for locally advanced or metastatic breast cancer - No more than 1 prior adjuvant chemotherapy regimen - At least 12 months since prior adjuvant taxane and recovered - More than 4 weeks since prior chemotherapy (more than 6 weeks since prior nitrosoureas, melphalan, or mitomycin) - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - More than 4 weeks since prior hormonal therapy - More than 1 week since prior hormonal therapy if documented tumor progression - No concurrent hormonal therapy except: - Steroids for documented CNS metastases, adrenal failure, septic shock, or prevention of serious allergic reaction or emesis OR - Hormonal therapy for nonmalignant conditions (e.g., insulin for diabetes) Radiotherapy: - See Disease Characteristics - No concurrent radiotherapy except whole brain irradiation for CNS disease Surgery: - More than 2 weeks since prior surgery, other than biopsy or placement of venous access device Other: - Concurrent bisphosphonate (e.g., pamidronate) therapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewSeidman, Study Chair, Memorial Sloan-Kettering Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
Lifespan: The Miriam Hospital
Providence, Rhode Island, 02906
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
California Cancer Center
Fresno, California, 93720
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
New York Weill Cornell Cancer Center at Cornell University
New York City, New York, 10021
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Additional Information:
Study ID Numbers: CDR0000066468; CLB-9840,CTSU
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003440
Other Recurrent Breast Cancer Studies:
1. Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
2. Oxaliplatin in Treating Women With Advanced or Metastatic Breast Cancer That Has Not Responded to Previous Chemotherapy
3. Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy
4. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
5. BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Virginia Clinical Trials
Other Norfolk Clinical Trials
Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
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