NCT06281210Recruiting
Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This single arm study aims to evaluate the efficacy and safety of a non-surgical approach, consisting of radiotherapy (RT) alone, for patients who have achieved a complete pathological response (pCR) following neoadjuvant chemotherapy (NACT). The study design involves the histological confirmation of pCR using vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) guided by ultrasound. The primary objective is to demonstrate that the non-surgical, RT-only treatment and follow-up approach is not inferior to the traditional surgical approach in patients with pCR after NACT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 77 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- 11 Dec 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- European Institute of Oncology
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06281210
What you commit to
- Study type: Interventional
- Planned participants: 77
- From 11 Dec 2023 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive history of previous breast cancer
Other illness
- Positive history of medical or psychiatric conditions preventing adherence to the protocol
Other
- Bilateral or multicentric tumour
- Presence of microcalcifications visualised on mammography
- Presence of associated DCIS
- High risk patient
Who the study is looking for
- age\> 18 years
- infiltrating breast carcinoma, non-special histotype, triple negative or HER2 +, T1-T2 N0
- single lesion
- neo-adjuvant chemotherapy treatment for at least 12 weeks according to clinical practice
- conservative surgery proposal
- M0
- tumour bed identified by breast markers placed in pre NACT by radiologist
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto di Candiolo, IRCCS Coordinator of this site? Confirm its status | Candiolo | Italy | Not yet recruiting |
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.