Clinical Trial: Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief 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 Summary:
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
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Current Primary Outcome: Difference in breast cancer mortality and overall survival between the two arms [ Time Frame: median follow-up time: 10 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Dates:
Date Received: December 15, 2011
Date Started: May 1998
Date Completion:
Last Updated: January 9, 2012
Last Verified: January 2012
