Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
NCT ID: NCT01508546
Last Updated: 2012-01-12
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
565 participants
INTERVENTIONAL
1998-05-31
2003-05-31
Brief Summary
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Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
Purpose
Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.
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Detailed Description
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To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.
Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.
PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years
ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: breast surgery with axillary lymphnodes removal
axillary dissection
Conservative breast surgery with or without axillary dissection
Arm 2: breast surgery without axillary lymphnodes removal
axillary dissection
Conservative breast surgery with or without axillary dissection
Interventions
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axillary dissection
Conservative breast surgery with or without axillary dissection
Eligibility Criteria
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Inclusion Criteria
* 18-65 years
Exclusion Criteria
* no other prior or concurrent malignancy except basal cell carcinoma
18 Years
65 Years
FEMALE
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Roberto Agresti, MD
Principal investigator
Principal Investigators
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Roberto Agresti, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
Locations
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Countries
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References
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Agresti R, Sandri M, Capri G, Bianchi G, Triulzi T, Lozza L, Trecate G, Trapani A, Ferraris C, Paolini B, Menard S, Greco M, Folli S, Tagliabue E. Axillary surgery versus no-axillary staging in T1N0 breast cancer: 20-year follow-up of the INT 09/98 randomized clinical trial. Br J Surg. 2025 Mar 4;112(3):znae311. doi: 10.1093/bjs/znae311.
Other Identifiers
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09/98
Identifier Type: -
Identifier Source: org_study_id
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