Minimally invasive detection of residual breast cancer after chemotherapy
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
This study is testing a new way to use a special biopsy technique to see if it can accurately find leftover breast cancer in patients who have already had chemotherapy, helping to avoid unnecessary surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT05951699 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of minimally invasive preoperative image-guided vacuum-assisted biopsy (VAB) in identifying residual breast and axillary disease in breast cancer patients who have undergone systemic neoadjuvant treatment. It focuses on patients with a complete clinical or radiological response or those with residual disease less than 1 cm. The study aims to improve the accuracy of detecting residual disease compared to traditional imaging techniques, which have shown variable reliability. By assessing the reliability of VAB, the study seeks to reduce unnecessary surgeries for patients who may not have residual disease.
Who should consider this trial
Good fit: Ideal candidates include breast cancer patients with cT1-cT2-cT3, cN0-cN1 disease who have achieved a complete clinical or radiological response after neoadjuvant chemotherapy.
Not a fit: Patients with multifocal disease, surgically inoperable conditions, or those who have not undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of residual breast cancer, potentially reducing overtreatment and improving patient outcomes.
How similar studies have performed: Other studies have shown promising results with similar minimally invasive techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriele Martelli, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian 1, 20133 Milan, Italy
- Study coordinator: Gabriele Martelli, MD
- Email: gabriele.martelli@istitutotumori.mi.it
- Phone: +39 02 2390 3436
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.