Vabb After Neoadjuvant Therapy to Avoid Surgery-pCR to Avoid Breast Surgery (BETTY-CRASY)

Non-inferiority Study in Patients With Complete Pathological Response After Neoadjuvant Chemotherapy and Negative VABB Biopsy Undergoing RT Alone, Omitting Surgical Treatment

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; Neoadjuvant Chemotherapy
• Intervention / Treatment: Procedure: Omission of surgical treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 77
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisabetta Rossi, MD; Phone Number: +39-0294372191; Email: ElisabettaMariaCristina.Rossi@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Elisabetta Rossi, MD; Phone Number: +390294372191; Email: ElisabettaMariaCristina.Rossi@ieo.it
    • Contact: Mara Negri; Email: mara.negri@ieo.it
    • Principal Investigator: Elisabetta Rossi, MD
  • Turin
    • Candiolo, Turin, Italy, 10060
      • Not yet recruiting
      • Istituto di Candiolo IRCCS
      • Contact: Antonio Toesca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omission of surgical treatment; Omission of surgical treatment in patients with complete pathological response after neoadjuvant chemotherapy and negative VABB biopsy	Procedure: Omission of surgical treatment; Omission of surgery in patients with pCR after neoadjuvant chemotherapy and negative VABB biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival	Absence of disease recurrence or progression, second primary tumor, or death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of MRI	Evaluation of the accuracy of breast MRI in predicting pCR following NACT	6 months
Contrast-Enhanced Mammography (CEM) positive predictive value	Evaluation of the accuracy of breast CEM in predicting pCR following NACT	6 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Elisabetta Rossi, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; HER2-positive breast cancer; Triple negative breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: IEO 2034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No