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| ID | Type | Description | Link |
|---|---|---|---|
| L2-439 | Other Identifier | Comitato Etico Territoriale Lombardia 2 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upfront Targeted Axillary Dissection (UTAD) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate of the retrieval of the deflector. | Number of successful retrieval of the deflector on the total number of surgeries. | 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. | Perioperative/Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with T0-T1-T2 ER+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 positive nodal citology/histology) M0 for whom neoadjuvant treatment is not recommended after a multidisciplinary discussion, between 18 and 90 years old willing and able to follow the study procedures and available for follow-up over the entire duration of the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viviana Galimberti, MD | Contact | +39 0257489717 | viviana.galimberti@ieo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU di Bologna - Policlinico di Sant'Orsola | Not yet recruiting | Bologna | Italy | 40138 | Italy |
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| 5 years from surgery. |
| AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni | Recruiting | Forlì | Italy | 47121 | Italy |
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| European Institute of Oncology | Recruiting | Milan | Italy | 20141 | Italy |
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| Fondazione IRCCS Istituto Nazionale Tumori di Milano | Not yet recruiting | Milan | Italy | 20133 | Italy |
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| Azienda Ospedaliera Universitaria Federico II | Not yet recruiting | Naples | Italy | 80131 | Italy |
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| Presidio Ospedaliero "G. Bernabeo" | Not yet recruiting | Ortona | Italy | 66026 | Italy |
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| Policlinico San Matteo | Recruiting | Pavia | Italy | 27100 | Italy |
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| Azienda Ospedaliera Universitaria Pisana | Not yet recruiting | Pisa | Italy | 56100 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | Italy | 00136 | Italy |
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| AO San Giovanni Addolorata | Not yet recruiting | Roma | Italy | 00184 | Italy |
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| IRCCS Humanitas Research Hospital | Recruiting | Rozzano | Italy | 20089 | Italy |
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| Azienda sanitaria universitaria Giuliano Isontina | Not yet recruiting | Trieste | Italy | 34148 | Italy |
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| ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi | Not yet recruiting | Varese | Italy | 21100 | Italy |
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| Ente Ospedaliero Cantonale | Not yet recruiting | Lugano | Switzerland | CH-6500 | Switzerland |
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