Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes. (NEONOD2)

  • STATUS
    Recruiting
  • End date
    Jun 21, 2027
  • participants needed
    850
  • sponsor
    Istituto Clinico Humanitas
Updated on 12 February 2022
carcinoma
metastasis
breast carcinoma
invasive breast cancer
axillary lymph node dissection

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.

Description

The study includes patients with cN+ positive axillary lymph nodes at initial diagnosis and who also have negative clinical and instrumental evaluation after NAC. Based on the sentinel lymph nodes definitive histological evaluation patients are allocated in one of the 2 comparison groups (Group 1 experimental or Group 2 standard) or in Group 3 internal control group. Group 3 is not used in statistical comparison with the other two groups but it's aim is to evaluate the appropriateness of the cases.

Referring to bio-pathologic characteristics after surgery patients will receive:

  • no further treatment
  • complementary radiotherapy
  • adjuvant medical therapy (hormonal therapy and/or biological therapy)
    Irradiation

Group 1 (experimental) and Group 2 (standard): irradiation won't be performed neither in the axillary region nor in the other lymph node stations

Group 3 (internal control): after conservative or radical surgery, patients will be subjected to loco-regional irradiation according to Guidelines.

Duration

Patients enrollment in the study protocol will last for 3 years. Patients will have to be followed for the subsequent 5 years during which they will have to undergo to periodic visits and follow-up checks provided for by the current standard guidelines:

  • clinical examination every six months for the first 5 years
  • mammography and breast ultrasound yearly
  • axillary ultrasound yearly

Details
Condition Breast Cancer
Treatment Axillary dissection, Omission of Axillary dissection
Clinical Study IdentifierNCT04019678
SponsorIstituto Clinico Humanitas
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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