Status:
COMPLETED
Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma
Lead Sponsor:
European Institute of Oncology
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
40-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT00970983
Start Date
March 1 1998
End Date
April 1 2010
Last Update
November 29 2011
Active Locations (1)
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1
European Institute of Oncology
Milan, Milano, Italy, 20141