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Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes Clinical research trials and Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes. Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes clinical trial. Test subjects typically receive the most expert healthcare available for their Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes  Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
For Condition: Breast Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group,Southwest Oncology Group,Cancer and Leukemia Group B,Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of combination chemotherapy in treating women who have stage II or stage IIIA breast cancer that has spread to the lymph nodes.
Details: OBJECTIVES: I. Compare the disease-free survival and overall survival in patients with node-positive or high-risk node-negative operable stage II or IIIA breast cancer treated with docetaxel or paclitaxel after doxorubicin and cyclophosphamide. II. Determine whether the weekly administration of paclitaxel or docetaxel for 12 weeks improves disease-free survival and overall survival when compared with the conventional schedule of every 3 weeks for 4 courses after doxorubicin and cyclophosphamide in this patient population. III. Compare the toxic effects of docetaxel and paclitaxel when administered weekly for 12 weeks versus every 3 weeks for 4 courses in these patients. IV. Compare the toxicity of paclitaxel administered every 3 weeks for 4 courses or weekly for 12 weeks to that of docetaxel administered on the same schedules in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative vs unknown), nodal status (0 positive nodes vs 1-3 positive nodes vs 4-9 positive nodes vs at least 10 positive nodes), tumor size (no more than 5 cm vs more than 5 cm vs unknown), and type of prior surgery (mastectomy vs breast conservation surgery). Patients are randomized to one of four treatment arms. Arm I: Patients receive doxorubicin IV and cyclophosphamide IV every 3 weeks for 4 courses (weeks 1-12). Beginning at week 13, patients receive paclitaxel IV over 3 hours every 3 weeks for 4 courses. Arm II: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive paclitaxel IV over 1 hour weekly for 12 weeks. Arm III: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour every 3 weeks for 4 courses. Arm IV: Patients receive doxorubicin and cyclophosphamide as in arm I. Beginning at week 13, patients receive docetaxel IV over 1 hour weekly for 12 weeks. Within 4 weeks after completion of chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen daily for 5 years. After completion of all chemotherapy, patients with prior segmental mastectomy receive radiotherapy once daily 5 days per week for 5-6 weeks. Patients with prior modified radical mastectomy may receive radiotherapy after chemotherapy completion at the investigator's discretion. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 5,000 patients will be accrued for this study within 1.27 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR high-risk node-negative disease (T2 or 3; N0) Primary tumor at least 2.1 cm in diameter for node-negative disease Bilateral breast disease allowed if at least 1 primary tumor meets the criteria above - Must have had at least 6 axillary lymph nodes removed at dissection and at least one node positive for metastasis OR Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed if enrolled on American College of Surgery Trial Z0011 and have been randomized to receive no axillary dissection) Additional axillary nodes may be obtained provided they are also negative for metastasis - Complete tumor removal by either a modified radical mastectomy or local excision plus axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node biopsy Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma except for lobular carcinoma in situ (less than 1 mm allowed) - Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP B-32 allowed - Hormone receptor status: Estrogen receptor status positive, negative, or unknown --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for breast cancer - Endocrine therapy: Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed Prior tamoxifen or other selective estrogen receptor modulator (SERM) for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., osteoporosis) allowed No concurrent tamoxifen or other SERMs - Radiotherapy: No prior radiotherapy for this malignancy At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ - Surgery: See Disease Characteristics Less than 84 days since prior surgical procedure to adequately treat primary tumor --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No history of myocardial infarction No congestive heart failure No significant ischemic or valvular heart disease - Other: No other prior invasive malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs (with Cremophor or polysorbate) Not pregnant or nursing Fertile patients must use effective barrier contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertComis, Study Chair, Eastern Cooperative Oncology Group
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Green Mountain Oncology Group
Bennington, Vermont, 05201
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, 52722
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Additional Information:
Study ID Numbers: CDR0000067353; E-1199
Study Start Date: October 1999
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004125
Other Breast Cancer Studies:
1. A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy with G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
2. Single-Dose Local Radiation Therapy Compared With Ibandronate in Treating Patients With Localized Metastatic Bone Pain
3. Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
4. Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer
5. A Randomized, Placebo-Controlled Trial of BMS-275291 Given Daily for 12 Months to Women with Stage 1c-IIIA Breast Cancer Receiving Adjuvant Chemotherapy and/or Hormonal Therapy
Related Studies:
Other Breast Cancer Clinical Trials
Other Maine Clinical Trials
Other Togus Clinical Trials
Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes
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