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Home > "S" Clinical Trials Conditions > Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer  Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
For Condition: stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): European Institute of Oncology ,
Synopsis: RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women with breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without axillary lymph node dissection following quadrantectomy in treating older women with stage I breast cancer that is estrogen receptor positive.
Details: OBJECTIVES: - Compare the efficacy of quadrantectomy with or without axillary lymph node dissection, followed by tamoxifen in terms of local and distant relapse rates and overall survival of patients with stage I, invasive breast cancer. - Determine the relationship between biological variables, such as hormone receptor status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph nodes. - Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients on both arms receive tamoxifen daily for 5 years. Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 65 Years/80 Years
Genders: Female
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven stage I, invasive breast cancer - Hormone receptor status: - Estrogen receptor positive - Progesterone receptor positive or negative PATIENT CHARACTERISTICS: Age: - 65 to 80 Sex: - Female Menopausal status: - Postmenopausal Performance status: - Not specified Life Expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - No serious disease that would preclude surgery - No other prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GabrieleMartelli, Study Chair, Istituto Nazionale per lo Studio e la Cura dei Tumori
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , 20133
Italy
Additional Information:
Study ID Numbers: CDR0000064573; CNR-9502,EU-95020
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002720
Other Stage 1 Breast Cancer Studies:
1. Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
2. Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer and Positive Axillary Lymph Nodes
3. Suppression of Ovarian Function Plus Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
4. Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
5. Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
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Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
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