Omitting axillary surgery after chemotherapy for certain breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether patients with micro metastatic sentinel lymph nodes can safely avoid axillary lymph node intervention after receiving neoadjuvant chemotherapy. It is a multicentric study conducted in Italy, comparing outcomes between patients who undergo axillary treatment and those who do not, based on their sentinel lymph node status post-chemotherapy. Participants will be monitored for five years to assess survival rates and recurrence risks, with a focus on ensuring that omitting surgery does not negatively impact patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: 18 ≤75 years
2. Breast carcinoma with infiltrating histotype
3. Tumor size: cT1 - cT2 - cT3
4. Positive axillary lymph nodes (cN +) at the initial diagnosis by clinical, ultrasound and cyto-microhistology evaluation
5. Neoadjuvant chemotherapy performed
6. Negative axillary lymph nodes (cN-) from the NAC by clinical and ultrasound assessment
7. Absence of distant metastases (M0)
8. Negative medical history for previous infiltrating breast cancer

Exclusion Criteria:

1. Current pregnancy or lactation status
2. Inflammatory breast cancer
3. In situ breast cancer
4. Synchronous contralateral breast cancer
5. Co-morbidity and/or medical disorder precluding any adjuvant therapy
6. Co-morbidity and/or medical/mental disorder making impossible making a regular follow-up
7. Other cancers in the previous 3 years (except forcarcinoma in situ of the uterine cervix, basalioma, squamous cell carcinoma or non-melanoma skin cancer)

Where it's running

• Istituto Clinico Humanitas
  Rozzano, Mi, Italy Recruiting

Study contacts

• Principal investigator: Corrado Tinterri, MD — Istituto Clinico Humanitas
• Study coordinator: Corrado Tinterri, MD
• Email: corrado.tinterri@cancercenter.humanitas.it
• Phone: +390282244012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.