Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
This study is currently recruiting participants.
Verified October 2010 by Centre René Gauducheau
Sponsor:
Centre René Gauducheau
Information provided by:
Centre René Gauducheau
ClinicalTrials.gov Identifier:
NCT01221688
First received: October 11, 2010
Last updated: October 14, 2010
Last verified: October 2010
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Purpose
GANEA 2 is a new trial based on patient treated for a large breast tumor with proven axillary involved nodes. Patients enrolled in this trial will have first an axillary sonography with fine needle punction in case of suspected nodes before NAC. This primary evaluation allow to determine two groups of patients : group 1 : patients with proven involved axillary nodes and group 2, patients without proven axillary involved nodes. Patients of group 1, the study group, will undergo SLNB and complete level I-II axillary lymphadenectomy. Patients of group 2 will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: Axillar Sentinel lymph node biopsy Procedure: SLNB and complete level I-II axillary lymphadenectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Centre René Gauducheau:
Primary Outcome Measures:
- false-negative rate for the Sentinel Lymph Node Detection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 858 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
group 2
patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
|
Procedure: Axillar Sentinel lymph node biopsy
Group 2 : Patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
|
|
Experimental: group 1
group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.
|
Procedure: SLNB and complete level I-II axillary lymphadenectomy
group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- T2-T3 operable infiltrating breast carcinoma
- No allergy to Patent Blue
- Pre-operative diagnosis of unilateral infiltrating breast carcinoma.
- Patient planned to be treated by NAC.
- Informed consent.
- Surgery available 4 to 6 weeks after the last chemotherapy course (radical or conservative surgery)
Exclusion Criteria:
- pT4d (inflammatory breast cancer)
- Locally advanced or metastatic breast cancer
- Any previous chemotherapy of contra-lateral breast cancer.
- Breast cancer local relapse
- Previous surgical removal of breast Cancer.
- Inadequate biopsy for pathological analysis.
- Dementia or altered mental disorder
- Pregnant woman or breast feeding or without efficacious contraceptive method.
- Contra-indication to NAC NAC interrupted due to progressive disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221688
Locations
| France | |
| Centre Paul Papin | Recruiting |
| Angers, France, 49000 | |
| Contact: Gérard Lorimier, MD g.lorimier@unimedia.fr | |
| Principal Investigator: Gérard Lorimier, MD | |
| CHU | Recruiting |
| Angers, France, 49 000 | |
| Contact: Philippe Descamps, MD phdescamps@chu-angers.fr | |
| Principal Investigator: Philippe Descamps, MD | |
| Institut Bergonié | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Christine Tunon de Lara, MD Tunon@bergonie.org | |
| Principal Investigator: Christine Tunon de Lara, MD | |
| CHU | Recruiting |
| Brest, France, 29609 | |
| Contact: Pierre François Dupré, MD pierre-francois.dupre@chu-brest.fr | |
| Principal Investigator: Pierre François Dupré, MD | |
| Centre Jean Perrin | Recruiting |
| Clermont Ferrand, France | |
| Contact: Pierre Guimbergues, MD Pierre.GIMBERGUES@cjp.fr | |
| Principal Investigator: Pierre Guimbergues, MD | |
| Centre Hospitalier | Recruiting |
| La Roche/yon, France | |
| Contact: Carole Damey, MD carole.damey@chd-vendee.fr | |
| Principal Investigator: carole Damey, MD | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59000 | |
| Contact: Sylvia Giard, MD s-giard@o-lambret.fr | |
| Principal Investigator: Sylvia Giard, MD | |
| Hôpital E. Herriot | Recruiting |
| Lyon, France, 69000 | |
| Contact: Patrice Mathevet, MD patrice.mathevet@chu-lyon.fr | |
| Principal Investigator: Patrice Mathevet, MD | |
| Centre Léon Berard | Recruiting |
| Lyon, France, 69 000 | |
| Contact: Christelle Faure, MD faure@lyon.fnclcc.fr | |
| Principal Investigator: Faure-Virelizier, MD | |
| Institut Paoli Calmette | Recruiting |
| Marseille, France, 13009 | |
| Contact: Gilles Houvenaeghel, MD houvenag@marseille.fnclcc.fr | |
| Principal Investigator: Gilles Houvenaeghel, MD | |
| Centre Val d'aurelle | Recruiting |
| Montpellier, France, 34298 | |
| Contact: Philippe Rouanet, MD Prouanet@valdorel.fnclcc.fr | |
| Principal Investigator: Philippe Rouanet, MD | |
| Centre Alexis Vautrin | Recruiting |
| Nancy, France, 54511 | |
| Contact: Frederic Marchal, MD f.marchal@nancy.fnclcc.fr | |
| Principal Investigator: Frederic Marchal, MD | |
| CHU Brabois | Active, not recruiting |
| Nancy, France, 54000 | |
| CHU | Recruiting |
| Nantes, France, 44000 | |
| Contact: Eric Darnis, MD Eric.darnis@chu-nantes.fr | |
| Principal Investigator: Eric Darnis, MD | |
| Hôpital Lariboisière | Recruiting |
| Paris, France, 75000 | |
| Contact: Emmanuel Barrarger, MD emmanuel.barranger@lrb.fr | |
| Principal Investigator: Emmanuel Barranger, MD | |
| Hôpital Saint Louis | Active, not recruiting |
| Paris, France, 75000 | |
| Hôpital Européen Georges Pompidou | Recruiting |
| Paris, France, 75000 | |
| Contact: Fabrice Lecuru, MD fabrice.lecuru@egp.aphp.fr | |
| Principal Investigator: Fabrice Lecuru, MD | |
| Hôpital Tenon | Recruiting |
| Paris, France, 75000 | |
| Contact: Roman Rouzier, MD roman.rouzier@tnn.aphp.fr | |
| Principal Investigator: Roman Rouzier, MD | |
| Institut Curie | Recruiting |
| Paris, France, 75 000 | |
| Contact: Servine Alran, MD severine.alran@curie.net | |
| Principal Investigator: Severine Alran, MD | |
| Clinique Lasagesse | Not yet recruiting |
| Rennes, France, 35000 | |
| Contact: Jérôme Blanchot, MD jblanchot@lasagesse.fr | |
| Principal Investigator: Jérôme Blanchot, MD | |
| Centre Eugène Marquis | Not yet recruiting |
| Rennes, France, 35511 | |
| Contact: Jean Levêque, MD jean.leveque@chu-rennes.fr | |
| Principal Investigator: Jean Levêque, MD | |
| Centgre René Becquerel | Recruiting |
| Rouen, France | |
| Contact: Marc Baron, MD Marc.baron@rouen.fnclcc.fr | |
| Principal Investigator: Marc Baron, MD | |
| Centre René Huguenin | Recruiting |
| Saint Cloud, France, 92210 | |
| Contact: Catherine Bellichard, MD c.belichard@stcloud-huguenin.org | |
| Principal Investigator: Catherine Bellichard, MD | |
| Centre René Gauducheau | Recruiting |
| Saint Herblain, France, 44805 | |
| Contact: Jean Marc Classe, MD +33240679900 | |
| Principal Investigator: Jean Marc Classe, MD | |
| Institut Gustave Roussy | Not yet recruiting |
| Villejuif, France | |
| Contact: Jean Remy Garbay, MD jean-remi.garbay@igr.fr | |
| Principal Investigator: Jean Remi Garbay, MD | |
Sponsors and Collaborators
Centre René Gauducheau
More Information
No publications provided
| Responsible Party: | Mme Scotet-Cérato, Centre René Gauducheau |
| ClinicalTrials.gov Identifier: | NCT01221688 History of Changes |
| Other Study ID Numbers: | BRD 09/9-G |
| Study First Received: | October 11, 2010 |
| Last Updated: | October 14, 2010 |
| Health Authority: | France : Afssaps |
Keywords provided by Centre René Gauducheau:
|
Sentinel lymph node biopsy (SLNB) large operable breast cancer neoadjuvant chemotherapy patients with large operable breast cancer after neoadjuvant chemotherapy (NAC) |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013