GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer

A Randomized, Phase III Clinical Trial GF-GS 01 to Compare Conventional Axillary Dissection Versus Sentinel Node Resection (GS) in Clinically Node-negative Operable Breast Cancer Unifocal N0 Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144898

Enrollment

1627

Registered

2005-09-05

Start date

2003-07-31

Completion date

2012-06-30

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, sentinel node resection, survival, Breast cancer unifocal N0

Brief summary

Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer. The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node. The duration of the follow-up is 5 years.

Interventions

PROCEDURESentinel Node Resection

Sentinel Node Resection

PROCEDUREConventional Axillary Dissection

Conventional Axillary Dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size \< 30 mm). * Written consent is obtained from all patients before randomization.

Design outcomes

Primary

Measure	Time frame
Survival without recurrence	5 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026