This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic Axillary Lymph Node Excision can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50
Phase III randomized multicenter equivalence trial evaluating the role of Axillary Lymph Node Excision. Primary aim is to assess if it is possible to avoid routine Axillary Lymph Node Excision during the initial treatment of breast cancers smaller than 11 mm in women aged 50 and older without compromising survival? The primary endpoint is overall survival: the event considered will be death from any cause.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
625
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Centre Hospitalier Universitaire d'Agen
Agen, France
Centre Régional de Lutte Contre le Cancer d'Anger
Angers, France
Number of Deaths
Time frame: Five years after surgery
Rate of Axillary Recurrence
Proportion of participants with axiallary recurrence. Axillary (Regional) recurrence is defined as tumor recurrence in lymph nodes draining the primary tumor site, namely, nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area.
Time frame: Five years after surgery
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...and 4 more locations