ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)
Conditions
Brief summary
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.
Detailed description
The patients that will avoid axillary lymph node dissection (ALND) meet all the criteria listed in the latest NCCN guidelines version.
Interventions
PROCEDUREUpfront Targeted Axillary Dissection (UTAD)
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.
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of T0-T1-T2 ER+/PR+ HER2- breast cancer with limited nodal involvement (1 or 2 suspicious lymph node on US, with at least 1 nodal positive cytology/histology) * M0 * Conservative surgery or mastectomy * Neoadjuvant treatment not recommended after a multidisciplinary discussion * Patients between 18 and 90 years old * Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study
Exclusion criteria
* Psychiatric, addictive or any disorder, which compromises ability to give informed consent for participation in the study * Personal history of invasive breast cancer * Other invasive malignancies diagnosed in the last five years * Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion * Contraindications to radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful rate of the retrieval of the deflector. | Perioperative/Periprocedural | Number of successful retrieval of the deflector on the total number of surgeries. |
| Prevention of Axillary Lymph Node Dissection | Perioperative/Periprocedural | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Axillary recurrence rate | 5 years from surgery. | 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. |
Countries
Italy, Switzerland
Contacts
CONTACTViviana Galimberti, MD
Outcome results
None listed