Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Upfront Targeted Axillary Dissection (UTAD)
Procedure/SurgeryDuring 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Successful rate of the retrieval of the deflector.
Number of successful retrieval of the deflector on the total number of surgeries.
Time frame
Perioperative/Periprocedural2
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/PeriproceduralSecondary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov