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Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer Clinical research trials and Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer. Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer  Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
For Condition: stage 2 breast cancer,stage 3 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This may lead to the development of secondary cancers. PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women with stage II or stage III breast cancer involving four to nine axillary lymph nodes.
Details: OBJECTIVES: I. Estimate the incidence of early genetic damage, defined by the presence of clonal hematopoiesis using the human androgen receptor assay (HUMARA), in pretreatment blood and bone marrow, apheresis, and two sequential post-treatment specimens from patients with stage II/III breast cancer enrolled in SWOG-S9623. II. Detect genetic damage following dose-intensive adjuvant regimens for breast cancer by screening for the presence of defective DNA mismatch repair mechanisms and loss of heterozygosity using microsatellite instability assays. III. Estimate the incidence of myeloid lymphoid leukemia gene fusion transcripts in cases where either the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis. IV. Determine the frequency of RAS gene mutations (H-, K-, and N-RAS) following dose-intensive adjuvant regimens for breast cancer. PROTOCOL OUTLINE: Prior to beginning treatment on SWOG-9623, blood samples and bone marrow aspirates (when available) are collected from each patient. Patients randomized to autologous peripheral stem cell transplant have specimens collected again at 3 months (apheresis aliquot and blood). At 3 and 12 months after completing chemotherapy, blood samples are collected from all patients. Samples are collected again from any patient presenting with a second malignancy in the future. DNA is collected from blood or bone marrow samples. Clonality at the HUMARA locus is examined. Microsatellite instability is assessed at multiple chromosomal loci: 7q31, 5q31, 17p12, 8p22, 11q23, and the BAT loci. If the HUMARA or microsatellite repeat assays are positive for clonal hematopoiesis, then specimens are examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid leukemia with 11q23 abnormalities. Specimens are also examined for RAS mutations (H-, K-, N-RAS). Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment. PROJECTED ACCRUAL: This study will accrue 100 patients for each arm of SWOG-9623, for a total of 200 patients.
Eligibility:
Study Type: Observational, Cross-Sectional
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven stage II/III breast cancer involving at least 4 axillary lymph nodes - Must be enrolled in SWOG-9623 at time of registration to this study, but must not have started treatment - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - See Disease Characteristics --Patient Characteristics-- - Age: Adult - Sex: Female - Menopausal status: Not specified - Performance status: See Disease Characteristics - Life expectancy: SWOG 0 or 1 - Hematopoietic: See Disease Characteristics - Hepatic: See Disease Characteristics - Renal: See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarilynSlovak, Study Chair, Southwest Oncology Group
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
CCOP - Kansas City
Kansas City, Missouri, 64131
United States
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Texas Tech University Health Science Center
Lubbock, Texas, 79423
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
United States
CCOP - Northwest
Tacoma, Washington, 98405-0986
United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
United States
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
University of Texas Medical Branch
Galveston, Texas, 77555-1329
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
CCOP - Columbus
Columbus, Ohio, 43206
United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
CCOP - St. Louis-Cape Girardeau
St. Louis, Missouri, 63141
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
CCOP - Dayton
Kettering, Ohio, 45429
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
United States
MBCCOP - University of South Alabama
Mobile, Alabama, 36688
United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
United States
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
United States
University of Colorado Cancer Center
Denver, Colorado, 80262
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
David Grant Medical Center
Travis Air Force Base, California, 94535
United States
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
St. Louis University Health Sciences Center
St. Louis, Missouri, 63110-0250
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
United States
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
United States
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
United States
Additional Information:
Study ID Numbers: CDR0000065813; SWOG-S9719
Study Start Date: November 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003095
Other Stage 2 Breast Cancer Studies:
1. Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
2. Tamoxifen, Ovarian Ablation, and/or Combination Chemotehrapy in Treating Premenopausal Women With Operable Invasive Breast Cancer
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer
4. Radiation Therapy Following Surgery in Treating Women With Early-Stage Invasive Breast Cancer
5. Chemotherapy in Treating Women With Resected Breast Cancer Following Tamoxifen Therapy
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Cincinnati Clinical Trials
Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer
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