Carcinoma, Ductal, Breast Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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