Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Institut Bergonié
- Enrollment
- 625
- Locations
- 25
- Primary Endpoint
- Number of Deaths
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women, 50 year or more Menopausal women Breast cancer Macroscopic tumor size of 10 mm or less (measured during operation) No palpable axillary node ( N0)
Exclusion Criteria
- •Previous cancer history life expectancy < 10 years Metastasis
Arms & Interventions
Conventional surgery WITH Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
Intervention: Conventional surgery WITH Axillary Lymph Node Excision (Procedure)
Conventional surgery WITHOUT Axillary Lymph Node Excision
Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
Intervention: Conventional surgery WITHOUT Axillary Lymph Node Excision (Procedure)
Outcomes
Primary Outcomes
Number of Deaths
Time Frame: Five years after surgery
Secondary Outcomes
- Rate of Axillary Recurrence(Five years after surgery)