NCT01508546

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Female Breast Neoplasms
• Carcinoma, Ductal, Breast

Interventions

Type	Name	Description
PROCEDURE	axillary dissection	Conservative breast surgery with or without axillary dissection

Timeline

• Start date: 1998-05-01
• Primary completion: 2003-05-01
• Completion: 2003-05-01
• First posted: 2012-01-12
• Last updated: 2012-01-12

Locations

1 site across 1 country: Italy