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Upfront Targeted Axillary Dissection for Luminal Breast Cancer With Limited Axillary Involvement

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About this study

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.

Condition
ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)
Tested
Upfront Targeted Axillary Dissection (UTAD)
Sponsor
European Institute of Oncology

Who can join

Age
18 to 90 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 90 years
  • Study condition: ALND, Sentinel Lymph Node Biopsy (SLNB), Targeted Axillary Dissection (TAD)
  • 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)
  • 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 5

  • 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

Where

14 sites, 14 recruiting

AUSL Romagna - Presidio Ospedaliero Morgagni-Pierantoni

Forlì, Italy, Italy

Recruiting

European Institute of Oncology

Milan, Italy, Italy

Recruiting

Policlinico San Matteo

Pavia, Italy, Italy

Recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, Italy

Recruiting

IRCCS Humanitas Research Hospital

Rozzano, Italy, Italy

Recruiting

IRCCS AOU di Bologna - Policlinico di Sant'Orsola

Bologna, Italy, Italy

Recruiting

and 8 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.