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Active, not recruitingNCT03876951NeoVABUpdated Feb 17, 2025

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)

An interventional study of Vacuum-assisted biopsy in Vacuum-assisted Biopsy, sponsored by Centre Georges Francois Leclerc. Active, not recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by Centre Georges Francois Leclerc · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Vacuum-assisted Biopsy

Keywords

  • breast cancer
  • neoadjuvant chemotherapy
  • vacuum-assisted biopsy
  • pathological complete response
03

In context

Lead sponsor

Centre Georges Francois Leclerc is the lead sponsor of 75 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
67 participants (estimated)

Study arms

  • Experimental
    vacuum-assisted biopsy

    Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery

    Diagnostic Test: Vacuum-assisted biopsy

Interventions

  • Diagnostic testVacuum-assisted biopsy

    Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the surgery

07

Study locations

1 site
  • Centre Georges François Leclerc
    Dijon, 21000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03876951
Lead sponsor
Centre Georges Francois Leclerc
Responsible party
Sponsor
First posted
Mar 15, 2019
Start date
Aug 30, 2019
Primary completion
Feb 28, 2025 (estimated)
Completion
Apr 8, 2025 (estimated)
Last update
Feb 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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