Histology VABB-Histology Post Surgery Pilot Project (BETTY Trial)

Overview

Pilot study on patients with invasive ductal breast cancer triple negative or HER2 +, N+/-, candidates to neoadjuvant chemotherapy.

The principal endpoint of the study will be the accuracy of the result of the histological examination of the Vacuum- Assisted Breast Biopsy (VABB) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at Magnetic resonance imaging (MRI) done after the end of neoadjuvant chemotherapy.

Full Title of Study: “Comparison Between Histological VABB and Histological Post-surgery in Patient With Complete Pathological Response After Neoadjuvant Systemic Treatment: Pilot Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Detailed Description

The study articulates in five phases:

Phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; Phase two: after radiological confirmation of pathological Complete Response pCR done performing breast ultrasound, MRI and 18 FDG TC PET after neoadjuvant chemotherapy the patient becomes candidate to VABB pre surgery.

Phase three: the patient has VABB within 15 day from the term of neoadjuvant chemotherapy Phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy Phase five: verification of correspondance between histology of VABB and definitive histology.

The study hypothesis is that VABB could be used in the patients with pCR to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of PET / TC and breast MRI to show the absence of breast cancer.

The use of VABB with negative histology result could bring to a therapeutic gold standard without over surgical treatment

Interventions

  • Procedure: vacuum-assisted breast biopsy
    • patient with radiological complete response after neoadjuvant chemotherapy undergo to vacuum assisted breast biopsy and the to definitive surgery

Arms, Groups and Cohorts

  • patient with radiological complete response
    • patient with radiological complete response after neoadjuvant chemotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of the accuracy of histological examination of the VABB performed pre-surgery
    • Time Frame: 45 days
    • Identification of percentage of cases with correspondance between histology of VABB presurgery and histology of definitive surgery in patients with complete radiological response after neoadjuvant chemotherapy

Participating in This Clinical Trial

Inclusion Criteria

  • age ≥ 18 aa;
  • histological diagnosis done at European Institute of Oncology (if not, to does revision of pathological material);
  • invasive ductal breast cancer triple negative or HER2 +, N+/-;
  • neoadjuvant standard systemic treatment after surgery +/- trastuzumab;
  • propose of conservative or demolitive surgery;
  • M0
  • cancer bed identified pre neoadjuvant chemotherapy by clip

Exclusion Criteria

  • multicentric or bilateral breast cancer
  • mammography microcalcifications
  • DCIS
  • positive anamnesis for previous breast cancer
  • positive anamnesis for medical or psicological conditions that prevent membership study

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • European Institute of Oncology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisabetta Rossi, MD, Principal Investigator, European Institute of Oncology
  • Overall Contact(s)
    • Elisabetta Rossi, MD, +390294372191, elisabetta.rossi@ieo.it

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