Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
NCT ID: NCT00002720
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
642 participants
INTERVENTIONAL
1995-12-31
2012-12-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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tamoxifen citrate
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
65 Years
80 Years
FEMALE
No
Sponsors
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European Institute of Oncology
OTHER
Principal Investigators
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Gabriele Martelli, MD
Role: STUDY_CHAIR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , Italy
Countries
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References
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Martelli G, Boracchi P, Ardoino I, Lozza L, Bohm S, Vetrella G, Agresti R. Axillary dissection versus no axillary dissection in older patients with T1N0 breast cancer: 15-year results of a randomized controlled trial. Ann Surg. 2012 Dec;256(6):920-4. doi: 10.1097/SLA.0b013e31827660a8.
Other Identifiers
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CNR-9502
Identifier Type: -
Identifier Source: secondary_id
EU-95020
Identifier Type: -
Identifier Source: secondary_id
CDR0000064573
Identifier Type: -
Identifier Source: org_study_id