NCT07278726 Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement
| NCT ID | NCT07278726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | ALND |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-28 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07278726 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying ALND. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07278726 currently recruiting?
Yes, NCT07278726 is actively recruiting participants. Contact the research team at viviana.galimberti@ieo.it for enrollment information.
Where is the NCT07278726 trial being conducted?
This trial is being conducted at Bologna, Italy, Forlì, Italy, Milan, Italy, Milan, Italy and 10 additional locations.
Who is sponsoring the NCT07278726 clinical trial?
NCT07278726 is sponsored by European Institute of Oncology. The trial plans to enroll 150 participants.