Omitting axillary surgery after chemotherapy for certain breast cancer patients
Breast Carcinoma T1-T2-T3 / cN +: Axillary Conservation of Lymph Nodes in the Presence of Micro Metastases in Sentinel Lymph Node, in cN- After Neoadjuvant Chemotherapy - Studio NEONOD 2
This study is testing if women with certain breast cancer can skip surgery on their lymph nodes after chemotherapy and still do just as well.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT04019678 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with infiltrating breast carcinoma and positive axillary lymph nodes who have undergone neoadjuvant chemotherapy and show negative lymph nodes post-treatment.
Not a fit: Patients with inflammatory breast cancer, in situ breast cancer, or those with significant co-morbidities that prevent follow-up or adjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for invasive surgeries in breast cancer patients, leading to improved quality of life and fewer complications.
How similar studies have performed: While similar approaches have been explored, this specific methodology of omitting axillary dissection in this patient population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rozzano, MI
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.