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Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm

Axillary node extension is one of the major prognostic factors in breast cancer. Axillary
dissection of Berg level I and II nodes is the validated method to obtain information on
lymph node invasion, but it is associated with important morbidity.

Sentinel lymph node assessment (SLN) was developed to select patients likely not to have
axillary node extension using a technique less invasive than conventional dissection.
Axillary dissection is restricted to patients with undetected or metastatic SLN.

SLN detection involves subareolar or peri-tumoral injection of lymphotropic contrast agents
which map the regional lymphatic drainage pattern of the tumor.

This technique allows an optimization of histopathological analysis: the pathologist must
analyze only two nodes on average (instead of 10-15), allowing the examination of numerous
tissue sections and the development of specific techniques such as immunohistochemistry.

The principal indicators of success for the technique are the detection rate, the false
negative rate and the number of SLN sampled.

The assessment of feasibility is based on concomitant histopathological analysis of the SLN
and of complementary lymph nodes.

There is no consensus in the literature on the SLN technique to be used for tumors with
clinical size superior to 2 cm in diameter.

The aim of this prospective, multicentric study is to evaluate the performance of the SLN
technique, in terms of detection rate and false negative rate, for patients with tumors
greater than 2 cm (clinical measurement).

A homogeneous technique with "combined", colorimetric and isotopic SLN detection with
subareolar or peri-tumoral injection will be used. This consensus "combined" technique has
been validated by all investigators. The histopathological procedure will also be
homogeneous, and validated within the group of pathologists of the Fédération Nationale des
Centres de Lutte Contre le Cancer (FNCLCC). Breast surgery will either be a mastectomy or
conservative treatment.

The primary objective of the study is to evaluate the quality criteria of the SLN detection
technique in breast cancer patients with a tumor size (clinical measurement) greater than 2
centimeters (rate of false negatives, rate of detection).

The secondary objectives are:

- Evaluation of the number of SLN sampled per patient,

- Lymphoscintigraphic evaluation of the pattern of lymphatic drainage in breast tumors >
2 centimeters,

- Precise histopathological description of the SLN sampled and of axillary nodes of
levels I and II.

Evaluation criteria:

The primary criterion is the rate of false negatives, determined by the ratio of the number
of patients with detected but negative SLN to the total number of positive non-sentinel
nodes at the time of axillary dissection of levels I and II (patients classified as N+
according to the TNM system).

This rate will be determined after calculation of the detection rate, determined by the
ratio of the number of patients evaluated on the total number of patients.

In agreement with international recommendations, the expected rate of false negatives should
be < 5 % with a detection rate > 85 %.

Secondary criteria include:

- Total number of sampled SLN per patient,

- Lymphoscintigraphy: detection of SLN by means of extra-axillary markings,

- Histopathological results:

- SLN: metastases, capsular breach, micro metastases, isolated cells,

- Dissection: number of positive nodes.

Inclusion Criteria:

- Female, age ≥ 18 years

- Patient with invasive unifocal breast cancer with tumor size > 2 cm at initial
examination (clinical examination and/or imaging)

- Preoperative histological diagnosis of infiltrating mammary carcinoma

- No lymph node at clinical examination

- No treatment for this cancer before surgery

- Mandatory affiliation with a social security system

- Written, signed informed consent

Exclusion Criteria:

- No invasive breast cancer

- Breast tumor =< 2 cm

- Preoperative histological diagnosis other than infiltrating mammary carcinoma

- Multifocal breast cancer

- Inflammatory breast cancer

- Metastatic cancer

- History of homolateral breast surgery

- History of allergic disorders

- History of homolateral breast cancer

- Difficult follow-up

- Pregnant or lactating woman

- Previous inclusion in the trial

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Quality criteria of the SLN detection technique

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Leon Berard, Lyon


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

March 2008

Completion Date:

September 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer (tumors> 2 cm)
  • Detection
  • Axillary sentinel lymph node
  • Breast Neoplasms