Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

Trial Title: Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery

NCT ID: NCT06281210

Condition: Breast Cancer
Triple Negative Breast Cancer
HER2-positive Breast Cancer
Neoadjuvant Chemotherapy

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms

Conditions: Keywords:
Triple negative breast cancer
HER2-positive breast cancer
neoadjuvant chemotherapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Omission of surgical treatment
Description: Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy
Arm group label: Omission of surgical treatment

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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 Exclusion Criteria: - Bilateral or multicentric tumour - Presence of microcalcifications visualised on mammography - Presence of associated DCIS - Positive history of previous breast cancer - Positive history of medical or psychiatric conditions preventing adherence to the protocol - High risk patient

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Istituto di Candiolo IRCCS

Address:
City: Candiolo
Zip: 10060
Country: Italy

Status: Not yet recruiting

Contact:
Last name: Antonio Toesca, MD

Facility:
Name: European Institute of Oncology

Address:
City: Milan
Zip: 20141
Country: Italy

Status: Recruiting

Contact:
Last name: Elisabetta Rossi, MD

Phone: +390294372191
Email: ElisabettaMariaCristina.Rossi@ieo.it

Contact backup:
Last name: Mara Negri
Email: mara.negri@ieo.it

Investigator:
Last name: Elisabetta Rossi, MD
Email: Principal Investigator

Start date: December 11, 2023

Completion date: December 31, 2028

Lead sponsor:
Agency: European Institute of Oncology
Agency class: Other

Source: European Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06281210