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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


Phase 3
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival without recurrence

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Gilles HOUVENAEGHEL, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli Calmette

Authority:

France: Ministry of Health

Study ID:

2003.312

NCT ID:

NCT00144898

Start Date:

July 2003

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • sentinel node resection
  • survival
  • Breast cancer unifocal N0
  • Breast Neoplasms

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