Breast Cancer Clinical Trial
Official title:
Prospective Clinical Trial to Assess a Mini-invasive Pre-surgical Procedure to Detect Residual Breast or Axillary Disease in Patients With cT1-T2-T3 cN0/N1 Breast Cancer in Complete Clinical/Radiological Remission After Primary Chemotherapy
Breast surgery may be overtreatment when there is a complete response to systemic neoadjuvant treatment as determined clinically and by imaging. However the reliability of imaging techniques (ultrasound, mammography and magnetic resonance) in identifying complete response varies in published studies and surgery remains the preferred method of detecting residual disease. The aims of this study are: 1. To assess the reliability of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment. 2. To assess the reliability of minimally invasive preoperative image-guided needle biopsy in identifying residual axillary disease in cT1-cT2-cT3, cN0-cN1 breast cancer patients, either with complete clinical/radiological response, or with residual breast disease <1 cm, after systemic neoadjuvant treatment. After neoadjuvant treatment, and evaluation with ultrasound, mammography and magnetic resonance, VAB will be performed on the breast, and needle biopsy will be performed on the axillary lymph node of pre-treatment cN1 cases, previously marked with a magnetic clip. The biopsy findings will be compared with the surgical findings, consisting in quadrantectomy or mastectomy plus sentinel node biopsy (or separate removal of tagged lymph nodes if they do not coincide with the sentinel node(s)) to assess the ability of biopsy to identify residual disease.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Radiologically confirmed unifocal cT1-cT2-cT3 cN0-cN1 breast cancer patients indicated for primary chemotherapy - Histologically confirmed HER2-positive, triple negative or luminal B HER2-positive invasive breast cancer - Clinical/radiological complete response or residual breast disease <1 cm after primary chemotherapy - Absence of locoregional relapse or distant metastasis - Signed informed consent to participate. Exclusion Criteria: - Disease surgically inoperable or surgery not performed - Multifocal disease or presence of microcalcifications at imaging. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Italy,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the accuracy of histological examination of the breast VAB performed pre-surgery | Identification of percentage of cases with correspondence between pre-operative VAB findings in breast with histological findings after quadrantectomy or mastectomy in patients with complete radiological response after neoadjuvant chemotherapy. | 40 days | |
Secondary | Evaluation of the accuracy of histological examination of the lymph node biopsy performed pre-surgery | Identification of percentage of cases with correspondence between pre-operative biopsy findings in tagged cN1 axillary lymph nodes with histological findings after sentinel node biopsy and surgical removal of the tagged node/s (if different from the sentinel node(s)). | 40 days |
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