Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer

Sponsor
Institut Bergonié
Study ID
NCT00210236
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Conventional surgery WITHOUT Axillary Lymph Node Excision — PROCEDURE
    Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision
  • Conventional surgery WITH Axillary Lymph Node Excision — PROCEDURE

Study Details

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

Key Dates

Start date
Sep 30, 1995
Status verified
Sep 2025
Primary completion
Dec 31, 2005
Completion
Dec 31, 2005

Study Design

Enrollment
625 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Conventional surgery WITH Axillary Lymph Node Excision
    Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision
  • Active Comparator: Conventional surgery WITHOUT Axillary Lymph Node Excision
    Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

Primary Outcome Measure

Number of Deaths [ Time Frame: Five years after surgery ]

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