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Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer


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

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Trial Information

Prospective Multicentric Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer


Inclusion Criteria:



- Age > 18 years

- Previous conservative surgical biopsy

- Secondary pathological diagnosis of infiltrative cancer

- No clinically involved axillary node (N0)

- No previous neoadjuvant treatment

- Performance status European Cancer Conference (ECCO) Grade ≤ 1

- Patient's written informed consent to participate in the study according to French
law

- Surgeon must have performed its learning curve

Exclusion Criteria:

- Lack of infiltrative breast carcinoma (in situ) pT4d > N0

- Breast cancer relapse

- Pregnancy

- Known patent blue allergy

- Indication for radical or partial mastectomy

- Patient unable to understand the trial

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

false negatives

Principal Investigator

Jean Marc Classe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Rene Gauducheau

Authority:

France: Ministry of Health

Study ID:

BRD 05/11-M

NCT ID:

NCT00293865

Start Date:

March 2006

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Breast infiltrative cancer
  • Breast Neoplasms

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