NCT06281210

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Neoadjuvant chemotherapy (NACT) in breast cancer is considered the \"gold standard\" for the treatment of locally advanced and inoperable malignancies. In recent years, in view of the evidence gathered, it has also become a conventional treatment alternative for patients with operable disease who are possible candidates for adjuvant chemotherapy. NACT thus aims to reduce mortality and increase surgical options, while at the same time allowing in vivo chemosensitivity testing. In view of this, NACT represents the ideal setting for clinical and translational research, which nowadays also has to address the question of future treatment options. It is indeed a source of lively debate whether chemotherapy should be considered the only possible treatment option for the patient. This study falls into this context, the innovative aim of which is to demonstrate histologically with the use of VABB, the complete pathological response (pCR) and to avoid surgery. The main aim of this study is to show that a non-surgical, radiotherapy-only treatment and follow-up approach is not inferior to a surgical approach for patients who have shown complete pathological response (pCR) following neoadjuvant chemotherapy (NACT), as confirmed through histological analysis of imaging-guided sampling. Histology will be performed by sampling 4 grams of tissue by vacuum-assisted biopsy (VABB) or vacuum-assisted excision (VAE) by ultrasound guidance (on breast marker). The hypothesis of the study is that the VAE/VABB will be used in patients with pCR at post-NACT imaging to demonstrate the absence of disease in the previous tumour bed and, accordingly, that the use of VAE/VABB with negative histology would lead to a gold standard of treatment without surgical overtreatment.

Conditions

• Breast Cancer
• Triple Negative Breast Cancer
• HER2-positive Breast Cancer
• Neoadjuvant Chemotherapy

Interventions

Type	Name	Description
PROCEDURE	Omission of surgical treatment	Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy

Timeline

• Start date: 2023-12-11
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

2 sites across 1 country: Italy