NCT04019678 Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.
| NCT ID | NCT04019678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 850 participants |
| Start Date | 2019-06-21 |
| Primary Completion | 2027-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 850 participants in total. It began in 2019-06-21 with a primary completion date of 2027-06-21.
⚠ 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
Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.
Eligibility 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)
Contact & Investigator
Corrado Tinterri, MD
PRINCIPAL INVESTIGATOR
Istituto Clinico Humanitas
Frequently Asked Questions
Who can join the NCT04019678 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04019678 currently recruiting?
Yes, NCT04019678 is actively recruiting participants. Contact the research team at corrado.tinterri@cancercenter.humanitas.it for enrollment information.
Where is the NCT04019678 trial being conducted?
This trial is being conducted at Rozzano, Italy.
Who is sponsoring the NCT04019678 clinical trial?
NCT04019678 is sponsored by Istituto Clinico Humanitas. The principal investigator is Corrado Tinterri, MD at Istituto Clinico Humanitas. The trial plans to enroll 850 participants.
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