Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast Cancer (AXIL95)

Institut Bergonié

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision; Procedure: Conventional surgery WITH Axillary Lymph Node Excision

Study type: Interventional

Funder types: Other

Identifiers

NCT00210236

IB1995-28

Details and patient eligibility

About

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

Full 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.

Enrollment: 625 patients

Sex: Female

Ages: 50 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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625 participants in 2 patient groups

Conventional surgery WITH Axillary Lymph Node Excision

Experimental group

Description:

Tumorectomy or mastectomy, WITH Axillary Lymph Node Excision

Treatment:

Procedure: Conventional surgery WITH Axillary Lymph Node Excision

Conventional surgery WITHOUT Axillary Lymph Node Excision

Active Comparator group

Description:

Tumorectomy or mastectomy, WITHOUT Axillary Lymph Node Excision

Treatment:

Procedure: Conventional surgery WITHOUT Axillary Lymph Node Excision