Clinical trial NCT06281210: Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery
Official title: Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Triple Negative Breast Cancer
HER2-positive Breast Cancer
Neoadjuvant Chemotherapy
Keywords: Triple negative breast cancer
HER2-positive breast cancer
neoadjuvant chemotherapy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 \&#34;gold standard\&#34; 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.

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

Primary outcomes:
measure: Event-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Positive predictive value of MRI
timeFrame: 6 months
measure: Contrast-Enhanced Mammography (CEM) positive predictive value
timeFrame: 6 months
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS
state: Turin
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Elisabetta Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References: