Breast CancerPhase 3NCT00144898
GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer
A Phase 3 study testing Sentinel Node Resection and Conventional Axillary Dissection in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Sentinel Node Resection and Conventional Axillary Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,627 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2003to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Breast Cancer
- Being tested
- Sentinel Node Resection, Conventional Axillary Dissection
- Keywords
- Breast cancer, sentinel node resection, survival, Breast cancer unifocal N0
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Node ResectionProcedure or surgery
Sentinel Node Resection
Conventional Axillary DissectionProcedure or surgery
Conventional Axillary Dissection
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Node Resection | Experimental | Sentinel Node Resection Receives: Procedure: Sentinel Node Resection |
| Conventional Axillary Dissection | Other | Conventional Axillary Dissection Receives: Procedure: Conventional Axillary Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles HOUVENAEGHEL, MD, Principal investigator, Institut Paoli Calmette
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144898
- Sponsor's protocol ID
- 2003.312
- Status last verified
- Jul 2013
- First submitted
- 2 Sep 2005
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Roy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res Treat. 2018 Jul;170(2):303-312. doi: 10.1007/s10549-018-4733-y. Epub 2018 Mar 10.
PubMed 29526019
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00144898
- Acronym / sponsor ID
- 2003.312
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, sentinel node resection, survival, Breast cancer unifocal N0
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,627 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Node Resection | Experimental | Procedure: Sentinel Node ResectionSentinel Node Resection |
| Conventional Axillary Dissection | Other | Procedure: Conventional Axillary DissectionConventional Axillary Dissection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Node ResectionSentinel Node Resection | Procedure or surgery | Sentinel Node Resection |
| Conventional Axillary DissectionConventional Axillary Dissection | Procedure or surgery | Conventional Axillary Dissection |
Primary outcome
Survival without recurrence
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 29526019Roy P, Leizorovicz A, Villet R, Mercier C, Bobin JY. Systematic versus sentinel-lymph-node-driven axillary-lymph-node dissection in clinically node-negative patients with operable breast cancer. Results of the GF-GS01 randomized trial. Breast Cancer Res Treat. 2018 Jul;170(2):303-312. doi: 10.1007/s10549-018-4733-y. Epub 2018 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles HOUVENAEGHEL, MD principal investigator
Institut Paoli Calmette
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sentinel Node Resection and Conventional Axillary Dissection in people with Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival without recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.