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Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer (GANEA 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier:
NCT01221688
First received: October 11, 2010
Last updated: August 30, 2016
Last verified: August 2016

October 11, 2010
August 30, 2016
July 2010
July 2015   (final data collection date for primary outcome measure)
false-negative rate for the Sentinel Lymph Node Detection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01221688 on ClinicalTrials.gov Archive Site
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Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
Evaluation of Sentinel Lymph Node Detection After Neoadjuvant Chemotherapy for Large Operable Breast Cancer
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.
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Interventional
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Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Breast Cancer
  • 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.
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
858
July 2019
July 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01221688
BRD 09/9-G
No
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Institut Cancerologie de l'Ouest
Institut Cancerologie de l'Ouest
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Institut Cancerologie de l'Ouest
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP