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)

NCT03876951 | Active Not Recruiting

• 1 other identifier: NeoVAB
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vacuum-assisted Biopsy

Keywords

breast cancer; neoadjuvant chemotherapy; vacuum-assisted biopsy; pathological complete response

Outcome Measures

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.

  During the surgery

Study Arms (1)

vacuum-assisted biopsy

EXPERIMENTAL

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

Diagnostic Test: Vacuum-assisted biopsy

Interventions

Vacuum-assisted biopsy DIAGNOSTIC_TEST

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

vacuum-assisted biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or older.
• Written informed consent provided.
• Triple negative or HER2-positive / ER-negative or HER2-positive / ER-positive breast tumours.
• Patients eligible for breast conservation after NAC.
• 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.
• Clinical complete response after NAC.
• Radiological (mammography, breast US, breast MRI) complete response after NAC.
• Patients predicted to be node-negative at treatment initiation.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 15, 2019
• Study Start: August 30, 2019
• Primary Completion: February 28, 2025
• Study Completion: April 8, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

FR (1)