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:

Information provided by:

Centre René Gauducheau

ClinicalTrials.gov Identifier:

NCT01221688

First received: October 11, 2010

Last updated: October 14, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 11, 2010
Last Updated Date	October 14, 2010
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	July 2018 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 14, 2010)	false-negative rate for the Sentinel Lymph Node Detection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01221688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
Official Title ^ICMJE	Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	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. 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.
Study Arm (s)	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. Intervention: Procedure: Axillar Sentinel lymph node biopsy Experimental: group 1 group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy. Intervention: Procedure: SLNB and complete level I-II axillary lymphadenectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	858
Completion Date	Not Provided
Estimated Primary Completion Date	July 2018 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01221688
Other Study ID Numbers ^ICMJE	BRD 09/9-G
Has Data Monitoring Committee	No
Responsible Party	Mme Scotet-Cérato, Centre René Gauducheau
Study Sponsor ^ICMJE	Centre René Gauducheau
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centre René Gauducheau
Verification Date	October 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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