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Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases Clinical research trials and Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases. Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases clinical trial. Participants frequently obtain the most expert healthcare available for their Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases  Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): International Breast Cancer Study Group ,
Synopsis: RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph nodemicrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: Randomizedphase III trial to compare the effectiveness of surgical resection with or without axillary lymph node dissection in treating women who have node-negative breast cancer and sentinel lymph node micrometastases.
Details: OBJECTIVES: Primary - Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection. Secondary - Compare overall survival of patients treated with these regimens. - Compare quality of life of patients treated with these regimens. - Compare the incidence of reappearance of disease in the undissected axilla, sites of first failure, and short- and long-term surgical complications in patients treated with these regimens. - Correlate pathological features of disease with outcome in patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo surgical resection of the primary tumor with axillary lymph node dissection. - Arm II: Patients undergo surgical resection of the primary tumor without axillary lymph node dissection. Patients in both arms may receive adjuvant therapy based on biological factors determined on the primary tumor or subsequent disease recurrence. Quality of life is assessed at baseline, every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter. Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 13,000 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma - Tumor no greater than 3 cm - Palpable or nonpalpable breast lesion - Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions - Prior (preoperative) or planned (intraoperative) sentinel node biopsy required - One and only one micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension - No clinical evidence of distant metastases - No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following: - Skeletal pain of unknown cause - Elevated alkaline phosphatase - Bone scan showing hot spots - No palpable axillary lymph node(s) - No Paget's disease without invasive cancer - Hormone receptor status: - Estrogen receptor and progesterone receptor known PATIENT CHARACTERISTICS: Age - Any age Sex - Female Menopausal status - Any status Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - See Disease Characteristics Renal - Not specified Other - Not pregnant or nursing - No other prior or concurrent malignancy except the following: - Adequately treated basal cell or squamous cell skin cancer - Adequately treated carcinoma in situ of the cervix - Contralateral or ipsilateral carcinoma in situ of the breast - No psychiatric, addictive, or other disorder that may compromise ability to give informed consent - Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No prior systemic therapy for breast cancer - More than 1 year since prior chemopreventive agent
Total Enrollment:
Location and Contact Information:
Overall Study Official:
UmbertoVeronesi, , European Institute of Oncology
European Institute of Oncology *Recruiting*
Milano, , 20141
Italy
Recruiting Viviana Galimberti 39-257-489-717
Additional Information:
Study ID Numbers: CDR0000339581; EU-20319,IBCSG-23-01
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072293
Other Stage 2 Breast Cancer Studies:
1. Medroxyprogesterone in Treating Women With Breast Cancer
2. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
3. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
4. Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
5. Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
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Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
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