Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Study Overview
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Brief Summary
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Rationale 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.

Detailed Description
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OBJECTIVES: 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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Female Breast Neoplasms, Carcinoma, Ductal, Breast

Intervention / Treatment
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* Procedure: axillary dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women with T1N0M0 invasive breast cancer 18-65 years Exclusion Criteria: bilateral breast cancer no other prior or concurrent malignancy except basal cell carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: breast surgery with axillary lymphnodes removal<br> | Procedure: axillary dissection<br>* Conservative breast surgery with or without axillary dissection<br>|
| Experimental: Arm 2: breast surgery without axillary lymphnodes removal<br> | Procedure: axillary dissection<br>* Conservative breast surgery with or without axillary dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in breast cancer mortality and overall survival between the two arms |  | median follow-up time: 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, axillary dissection