The present study aims to avoid axillary lymph node dissection (ALND) in patients with an Ultrasound (US) detected positive preoperative lymph node involvement (1 or 2 suspicious lymph-nodes) and a needle histology/cytology placing a marker in the most suspicious node undergoing upfront surgery if neoadjuvant treatment is not indicated. The marked lymph node will be retrieved along with sentinel lymphnode(SLN)(s) to minimize the false-negative rate and only in case of ≥3 positive SLNs ALND will be performed, in order to minimize surgical overtreatment among women with preoperatively confirmed axillary nodal metastasis.
The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.
Study Type
OBSERVATIONAL
Enrollment
150
During the surgical intervention lymphnodes excised both with reflector localization and Gamma probe will be sent for pathological examination and only in case of more than 2 metastatic lymph nodes (and at least one of them with macrometastasis) axillary dissection will be performed.
IRCCS AOU di Bologna - Policlinico di Sant'Orsola
Bologna, Italy, Italy
NOT_YET_RECRUITINGAUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni
Forlì, Italy, Italy
NOT_YET_RECRUITINGEuropean Institute of Oncology
Milan, Italy, Italy
RECRUITINGFondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, Italy, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Federico II
Napoli, Italy, Italy
NOT_YET_RECRUITINGPresidio Ospedaliero "G. Bernabeo"
Ortona, Italy, Italy
NOT_YET_RECRUITINGPoliclinico San Matteo
Pavia, Italy, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Pisana
Pisa, Italy, Italy
NOT_YET_RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, Italy
NOT_YET_RECRUITINGAO San Giovanni Addolorata
Roma, Italy, Italy
NOT_YET_RECRUITING...and 4 more locations
Successful rate of the retrieval of the deflector.
Number of successful retrieval of the deflector on the total number of surgeries.
Time frame: Perioperative/Periprocedural
Prevention of Axillary Lymph Node Dissection
Total number of patient that did not received but were elegible for Axillary Lymph Node Dissection by the current guidelines on the total number of surgeries.
Time frame: Perioperative/Periprocedural
Axillary recurrence rate
The secondary endpoint is the rate of axillary recurrence in patients undergoing UTAD and who avoid AD. Cumulative incidence of axillary recurrence as first event will be calculated, considering the following events as competing: distant metastases, death, second primary malignancies, invasive ipsilateral tumor recurrences in the breast or chest wall, supraclavicular or internal mammary recurrences, and contralateral invasive cancers.
Time frame: 5 years from surgery.
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