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NCT05951699
Mini-invasive Detection of Residual Disease in Breast Cancer Patients in Remission After Primary Chemotherapy
trial testing minimally invasive preoperative image-guided vacuum-assisted biopsy in Breast Cancer in 105 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 105 |
| Start date | 28 April 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- minimally invasive preoperative image-guided vacuum-assisted biopsy
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano — full company profile →
Who can join
Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05951699
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05951699 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Last refreshed: 19 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05951699.
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