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A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Invasive Breast Cancer

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Trial Information

A Non Inferiority Randomized Multicenter Phase III Trial of Axillary Node Dissection Versus no Axillary Node Dissection in Case of Positive Sentinel Lymph Node in Invasive Breast Cancer


Inclusion Criteria:



1. - Patient aged 18 years and above,

2. - Patient with invasive breast cancer histologically proven or cytologically proven
by fine needle biopsy,

3. - Patient with a unifocal tumor T0 - T1 - T2 up to 5 cm (clinical or in imagery),
without previous therapy (neoadjuvant chemotherapy or hormone therapy),

4. - Patient with clinical N0 status,

5. - Absence of clinically detectable metastases known,

6- Patients for whom conservative surgery with sentinel lymph node (SLN) technique is
feasible from the start in terms of carcinologic,

7 -All patients with lymph node involvement (GS+), whatever the size of the metastasis
(macro-metastasis, micro-metastasis, cellular cluster or isolated tumor cells),

8 - Patient affiliated to a social security system or benefiting from such a system,

9 - Signed consent to participate.

Exclusion Criteria:

1. - Tumor of more than 5 cm

2. - Indication of neoadjuvant therapy by chemotherapy or hormone therapy

3. - History of breast cancer (ipsilateral, ie recurrence, or contralateral breast)

4. - History of any other invasive cancer other than a past cutaneous cancer correctly
treated

5. - Initial metastatic disease known

6. - Presence of clinical axillary adenopathy

7. - Contra-indication to surgical excision

8. - Contra-indication to the SLN technique

9. - Pregnant women, of child-bearing potential, or lactating women

10- Patient deprived of liberty or under supervision of a guardian

11- Impossibility to undergo medical examinations of the study for geographical, social or
psychological reasons.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease Free survival

Outcome Description:

time from randomization to relapse or death.

Outcome Time Frame:

Time to relapse or progression up to 10 years

Safety Issue:

No

Principal Investigator

Gilles HOUVENAEGHEL, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

SERC / IPC 2012-001

NCT ID:

NCT01717131

Start Date:

July 2012

Completion Date:

July 2025

Related Keywords:

  • Invasive Breast Cancer
  • Invasive breast cancer
  • Breast Neoplasms

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