Evaluation of the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB) (NeoVAB)

Prospective Multicenter Pilot Study to Evaluate the Accuracy of Percutaneous Biopsy by Vacuum-assisted Biopsy (VAB) to Assess Pathological Complete Response in Patients With Clinical and Radiological Complete Response After Neoadjuvant Chemotherapy (NeoVAB)

Breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death in females in the world. Neoadjuvant chemotherapy (NAC) is increasingly used in patients with operable breast cancer to enhance the likelihood of breast conservation. New generation of treatments or combinations lead to a high rate of pathological complete responses (pCR) in patients with human epidermal growth factor receptor 2 positive (HER2) and triple negative tumours. Safe omission of surgery in patients who receive NAC and achieve radiologic complete response depends on the ability to accurately estimate pCR preoperatively.

If pathological complete response after NAC could be accurately assessed by VAB, surgery could be avoided. In the context of new treatments or combinations with an increased pCR rate, this new strategy could induce major changes in clinical practice, leading to breast surgery de-escalation.

Study Overview

• Status: Recruiting
• Conditions: Vacuum-assisted Biopsy
• Intervention / Treatment: Diagnostic test: Vacuum-assisted biopsy

Detailed Description

A total of 66 patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery. The primary endpoint of the study is the false negative rate of VAB procedure. This rate will be calculated by comparing the detection of invasive or in situ carcinoma on surgical specimen versus VAB samples. The secondary endpoints of the study are feasibility, VAB procedure technical complications and safety.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles COUTANT; Phone Number: 33.3.80.73.75.00; Email: CCoutant@cgfl.fr
• Study Contact Backup: Name: Emilie REDERSTORFF; Phone Number: 03 45 34 81 16; Email: erederstorff@cgfl.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Centre Georges Francois Leclerc
    • Principal Investigator: Charles COUTANT
    • Contact: Emilie REDERSTORFF; Phone Number: 03 45 34 81 16; Email: erederstorff@cgfl.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient aged 18 years or older.
2. Written informed consent provided.
3. Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
4. Patients eligible for breast conservation after NAC.
5. Patients with T2-T3 N0 invasive breast cancer initially treated by NAC to allow breast conservation, who have received a minimum of 6 cycles of adequate NAC +/- anti-HER2.
6. Clinical complete response after NAC.
7. Radiological (mammography, breast US, breast MRI) complete response after NAC.
8. Patients predicted to be node-negative at treatment initiation.

Exclusion Criteria:

1. Patient younger than 18 years old.
2. Pregnant or breastfeeding women.
3. Proven metastatic axillary or internal mammary chain lymph node involvement before NAC proven by biopsy or cytology.
4. Bilateral breast cancer.
5. Contraindication to MRI.
6. Contraindication to breast conservation
7. Patients with a BRCA mutation or other autosomal dominant high-penetrance genetic predisposition to breast cancer.
8. Patients with limitation of freedom or under guardianship
9. Inability for psychological reasons
10. Hypersensitivity to local anaesthesia
11. Initial imaging showing ACR6 micro calcifications and/or ACR6 non-mass enhancement associated to the index lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: vacuum-assisted biopsy; Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery	Diagnostic test: Vacuum-assisted biopsy; Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False negative rate of vacuum-assisted biopsy	Absence of invasive and in-situ carcinoma on vacuum-assisted biopsy but presence of invasive or in-situ carcinoma on the surgical specimen.	During the surgery

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): April 8, 2025

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant chemotherapy; pathological complete response; vacuum-assisted biopsy
• Other Study ID Numbers: NeoVAB

Drug and device information, study documents

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