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Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size

40 Years
75 Years
Not Enrolling
Breast Carcinoma

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Trial Information

Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size

The axillary lymph nodes represent the most frequent site of metastasis from breast
carcinoma. In previous studies, it has been shown that the process of metastasis to the
axillary nodes proceeds in an orderly and progressive fashion from the I to the II and to
the III level and that a "saltatory" event of metastasis represents a rare event described
in only 2% to 6% of cases.

The risk of metastasis is directly correlated with the size of the primary tumor. When
smaller than 1 cm in diameter, the risk of metastasis is about 10%; when larger than 5 cm in
diameter, the risk increases to more than 70%.

The involvement of axillary lymph nodes by metastases constitutes today the most important
prognostic factor in breast cancer. Massive invasion is most certainly associated with a
poor outcome and therefore, the information that the lymph node status can provide, is
indispensible for administration of appropriate therapies in the postoperative period.
Nevertheless, in those cases where the lymph nodes are found to be free of metastases,
axillary dissection is a useless treatment that can prove harmful if one considers all the
possible short and long term complications.

Presently, there are no diagnostic modalities that are able to provide an accurate lymph
node staging preoperatively. This information can only be gained by histologic examination
of all lymph nodes after complete axillary dissection.

Standard treatment for operable breast cancer today always involves the dissection of the
axillary lymph nodes, regardless of the surgical procedure used for resection of the primary
tumor, i.e. conservative or demolitive. This not only results in a large expenditure of
resources (longer surgical procedures under general anesthesia), but most notably, in an
increased risk of complications (lymphedema and functional limitations of the involved
extremity) for the patient, secondary to a more aggressive intervention on the axilla.

A method utilizing preoperative lymphoscintigraphy and intraoperative use of a gamma-ray
probe in order to evaluate the possibility of metastasis in the first axillary lymph node,
i.e. the "sentinel node", has recently been put into practice at our institute. This method,
which in its first part consists in the subcutaneous or peritumoral administration of a
radiolabeled (99Tc) human albumin colloid (see methods section), has allowed isolation and
excision of the sentinel lymph node with the use of the gamma-ray probe in 98.8% of cases.

In the case that this procedure should prove highly predictable of patient outcome, numerous
axillary lymphadenectomies could be avoided and with such, numerous complications associated
with such aggressive intervention.

A first phase study has evaluated 238 patients with breast carcinoma that would be
candidates for complete axillary dissection. Patients with intraductal carcinoma, those
candidates for primary chemotherapy, those diagnosed during pregnancy or lactation, and
those with tumors less than 1 cm in size (because of inclusion in the randomized trial (053)
evaluating the role of radiotherapy on the axilla in patients undergoing conservative
surgery without axillary node dissection) were excluded from the study. The results of this
first phase have shown a concordance in the histologic findings between the sentinel lymph
node and all remaining axillary lymph nodes, subdivided into three levels, in 96.7% of
cases. Furthermore, concordance was 100% in 18 patients with breast carcinoma of a size
equal or less than 1.0 cm.

Inclusion Criteria:

- Age between 40 and 75 years.

- Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with
an ultrasonographic diameter of equal or less than 2.0 cm.

- Although not a factor of exclusion, a breast scintigraphy using MDP-99m is
recommended for accurate determination of possible multifocality or multicentricity
of the tumor, as well as for the determination of possible bone metastasis.

- Axillary lymph nodes that cannot be palpated or that are not clinically suspicious
for metastasis.

- No previously executed therapy (including biopsy) at any outside institution.

- Those patients with nonpalpable lesions will be subjected to preoperative radioactive
occult lesion localization (ROLL) or stereotactic biopsy.

- Adequate patient information and signature of the informed consent.

Exclusion Criteria:

- Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma.

- Paget's disease.

- Documented multicentricity and/or abundant multifocality of the neoplasm.

- Clinically metastatic lymph nodes.

- Patients previously biopsied at other institutions.

- Carcinomas detected during pregnancy or lactation.

- Histotypes diverse from breast carcinoma lesions.

- History of previous malignancy (excluding basocellular carcinoma, in-situ cervical
carcinoma and/or contralateral breast carcinoma without recurrence for at least 15
years of follow-up).

Type of Study:


Study Design:

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

Outcome Measure:

disease free survival, overall survival

Outcome Time Frame:

every 6 months for the first 5 years and every 8 months afterwards

Safety Issue:


Principal Investigator

Umberto Veronesi, MD

Investigator Role:

Study Director

Investigator Affiliation:

European Institute of Oncology


Italy: Ministry of Health

Study ID:

IEO 185



Start Date:

March 1998

Completion Date:

April 2010

Related Keywords:

  • Breast Carcinoma
  • Breast Neoplasms
  • Carcinoma