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Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery Clinical research trials and Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery clinical trial. Human subjects often get the best healthcare possible for their Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery  Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
For Condition: stage 3C breast cancer,stage 2 breast cancer,stage 4 breast cancer,stage 3A breast cancer,stage 3B breast cancer,inflammatory breast cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Comparing results of diagnostic procedures performed before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the most effective treatment. PURPOSE: Diagnostic trial to study magnetic resonance imaging (MRI) and biomarkers in women who are receiving chemotherapy before surgery for locally advanced breast cancer.
Details: OBJECTIVES: - Support accrual to the ACRIN-6657/CALGB-150012 magnetic resonance imaging (MRI) correlative science study. - Determine whether molecular markers, alone or in combination with MRI, at the time of diagnosis or early in the course of therapy, predict 3-year disease-free survival (DFS) in women with locally advanced breast cancer who are receiving neoadjuvant chemotherapy. - Identify two groups of participants who have statistically different 3-year DFS, based on 1 or more biomarkers, including MRI. - Determine whether biomarkers, in combination with MRI, early in the course of chemotherapy, improve the prediction of 3-year DFS and are at least as good of a predictor of DFS as residual disease at the time of surgery in these patients. - Determine whether molecular markers are associated with specific imaging patterns seen on MRI of these patients. - Predict response with MRI results and marker data from cell cycle check points, proliferation, angiogenesis, hormone receptors, and molecular profiles in these patients. OUTLINE: This is a diagnostic, multicenter study conducted concurrently with CALGB-150012/ACRIN-6657 imaging protocol and concurrently with neoadjuvant anthracycline-based chemotherapy. Patients receive an injection of gadopentetate dimeglumine and undergo magnetic resonance imaging (MRI) of the breast before initiation, 2 weeks after initiation, and then after completion of neoadjuvant anthracycline-based chemotherapy and prior to surgery. Patients who previously received a taxane also undergo an additional contrast-enhanced MRI scan. Patients undergo biopsies before initiation, 1-4 days after initiation, after completion of neoadjuvant anthracycline-based chemotherapy, at the time of surgery, and at the beginning of taxane chemotherapy (if applicable). Patients also undergo blood draws at the time of the first biopsy and 2-4 days after initiation of anthracycline therapy. Serum and tissue samples are used to assess biomarkers of genetic instability, cell cycle progression and cellular proliferation as predictors for anthracycline responsiveness, markers of apoptotic potential as predictors for taxane responsiveness in vivo, angiogenesis, hormone receptors, and molecular profiles using immunohistochemical methods. Mammograms and possibly ultrasounds are performed prior to and after chemotherapy (before surgery). Patients are followed every 6 months for 5 years and then annually for up to 10 years. PROJECTED ACCRUAL: A total of 244 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed adenocarcinoma of the breast by core needle biopsy, incisional biopsy, or fine needle aspiration (FNA) - Incisional biopsy must result in < 10% removal of gross residual disease - Measurable disease - At least 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm by spiral CT scan OR - Nonmeasurable disease - Meets one of the following staging criteria: - Stage II or III disease - T4, any N, M0, including clinical or pathologic inflammatory disease - Regional stage IV disease where supraclavicular/infraclavicular lymph nodes are only site of metastasis - No clinical or imaging evidence of distant metastasis - Metaplastic carcinomas allowed - Synchronous bilateral primaries allowed if the more advanced tumor meets staging criteria - Patients for whom FNA was used to confirm initial diagnosis must have histologically confirmed invasive carcinoma by the start of chemotherapy - Her-2/neu status known - Currently receiving a neoadjuvant anthracycline-based regimen alone or followed by a taxane - Concurrent enrollment in the ACRIN-6657/CALGB-150012 imaging protocol required - Hormone receptor status: - Any estrogen receptor or progesterone receptor status PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No uncontrolled or severe cardiovascular disease Other - Not pregnant or nursing - Negative pregnancy test - No ferromagnetic prostheses including the following: - Metallic implants not compatible with a magnetic resonance imaging machine - Heart valves - Aneurysm clips - Orthopedic prosthesis - Any metallic fragments anywhere in the body PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior chemotherapy to the ipsilateral breast for this malignancy Endocrine therapy - At least 4 weeks since prior tamoxifen or raloxifene Radiotherapy - No prior radiotherapy to the ipsilateral breast for this malignancy Surgery - Not specified Other - No other prior cytotoxic regimens
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LauraEsserman, Study Chair, University of California, San Francisco
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7305
United States
Recruiting Lisa Carey 919-966-4431
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
Additional Information:
Study ID Numbers: CDR0000069280; CALGB-150007
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033397
Other Stage 2 Breast Cancer Studies:
1. Tamoxifen With or Without Combination Chemotherapy in Treating Postmenopausal Women With Operable Invasive Breast Cancer
2. Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
3. Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer
4. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
5. Trastuzumab and Chemotherapy Followed by Surgery and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
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