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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer  Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
For Condition: cardiac toxicity,stage 4 breast cancer,stage 3B breast cancer,stage 3A breast cancer,inflammatory breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer.
Details: OBJECTIVES: I. Determine the time to locoregional recurrence, time to completion of treatment, and overall survival in women with HER-2+ stage IIIA or IIIB or regional stage IV breast cancer treated with doxorubicin and cyclophosphamide with or without dexrazoxane, followed by paclitaxel with or without trastuzumab (Herceptin), followed by surgery and radiotherapy with or without trastuzumab. II. Determine whether addition of trastuzumab to paclitaxel therapy improves response at 24 weeks of therapy in these patients. III. Determine whether addition of trastuzumab to paclitaxel therapy increases the rate of cardiotoxicity in these patients. IV. Determine whether addition of dexrazoxane to doxorubicin and cyclophosphamide compromises response in these patients. V. Determine whether addition of dexrazoxane to doxorubicin and cyclophosphamide reduces the rate of cardiotoxicity in these patients. VI. Determine whether long-term trastuzumab after local therapy improves disease-free survival in these patients. VII. Determine whether long-term trastuzumab after local therapy increases the rate of cardiotoxicity in these patients. VIII. Determine the occurrence of any grade 3 or higher toxicity, second malignancies, acute myelogenous leukemia, or myelodysplastic syndrome in patients treated with these regimens. IX. Determine the eventual rate of breast conservation in those patients considered candidates for breast conservation prior to neoadjuvant treatment. X. Determine the clinical response after doxorubicin and cyclophosphamide with or without dexrazoxane and the clinical/mammographic/ultrasound response after paclitaxel with or without trastuzumab, compared to the pathologic response at definitive surgery in these patients. PROTOCOL OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to stage (inflammatory vs noninflammatory inoperable stage III/ regional stage IV vs operable stage III). Patients are randomized to 1 of 8 treatment arms. Arm I: Patients receive dexrazoxane IV over 10-20 minutes, doxorubicin IV over 5-10 minutes, and cyclophosphamide IV over 30 minutes on days 1, 22, 43, and 64. Patients receive paclitaxel IV over 1 hour and trastuzumab (Herceptin) IV over 30-90 minutes on days 85, 92, 99, 106, 113, 120, 127, 134, 141, 148, 155, and 162. Approximately 1-2 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conservation surgery, modified radical mastectomy, or mastectomy. Patients with unacceptable toxicity or locoregional disease progression may undergo surgery prior to week 24 (i.e., completion of neoadjuvant chemotherapy). Beginning 2-4 weeks after breast conservation surgery or 3-5 weeks after mastectomy, patients undergo radiotherapy daily 5 days a week for 6-8 weeks. Patients receive long-term trastuzumab IV over 30-90 minutes weekly for 40 weeks beginning on week 36 (day 254). Arm II: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel (without trastuzumab) as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm III: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patient undergo observation only for 40 weeks after completion of radiotherapy. Arm IV: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Arm V: Patients receive doxorubicin and cyclophosphamide (without dexrazoxane) as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm VI: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm VII: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Arm VIII: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Treatment continues in all arms in the absence of distant disease progression. Beginning within 12 weeks of completion of neoadjuvant chemotherapy, hormone receptor-positive patients may receive oral tamoxifen daily for 5 years. Patients are followed every 6 months for 5 years and then annually for 5 years. PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed primary infiltrating adenocarcinoma of the breast: Confirmed by core needle biopsy or incisional biopsy; Amplification of HER-2 by FISH OR Overexpression (3+) of HER-2 by immunohistochemistry; Staging criteria after complete clinical and radiographic staging: T3, N1, M0 OR Any T, N2 or N3, M0 OR T4, any N, M0, including clinical or pathological inflammatory disease OR Regional stage IV disease with supraclavicular or infraclavicular lymph nodes as only site of metastasis - Measurable or evaluable disease - Prior ductal carcinoma in situ of the ipsilateral breast allowed if treated with excision only without mastectomy or radiation - Metaplastic carcinoma allowed - Synchronous bilateral primary disease allowed (provided at least 1 cancer meets staging criteria) - No dermal lymphatic involvement with clinical inflammatory changes - Hormone receptor status: Estrogen receptor positive or negative; Progesterone receptor positive or negative --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: No more than 4 weeks of prior tamoxifen for disease; Prior tamoxifen or raloxifene for longer than 4 weeks as chemoprevention allowed; No concurrent tamoxifen or raloxifene; No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic - Radiotherapy: See Disease Characteristics; No prior radiotherapy for index malignancy; No prior radiotherapy to the ipsilateral breast, regional nodes, mediastinum, or heart; Prior radiotherapy to the contralateral breast for ductal carcinoma in situ or early stage invasive breast cancer allowed provided earlier radiotherapy does not preclude optimal delivery of study radiotherapy and criterion of low risk for metastasis from first malignancy is met - Surgery: See Disease Characteristics; No prior sentinel lymph node biopsy --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 1,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); AST no greater than 2 times ULN - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: LVEF normal by MUGA; No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) - Other: No other currently active malignancy except nonmelanoma skin cancer; Not pregnant or nursing; Fertile patients must use effective contraception; Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkGraham, Study Chair, Cancer and Leukemia Group B
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of North Carolina
Cary, North Carolina, 27511
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Missouri Baptist Cancer Center
St. Louis, Missouri, 63131
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Additional Information:
Study ID Numbers: CDR0000068617; CTSU,CLB-49808
Study Start Date: May 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016276
Other Cardiac Toxicity Studies:
1. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
2. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
3. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
4. Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer
5. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
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Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
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