Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Centre Georges Francois Leclerc
Conditions:
Vacuum-assisted Biopsy
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 r...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 8 2025
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03876951
Start Date
August 30 2019
End Date
April 8 2025
Last Update
February 17 2025
Active Locations (1)
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1
Centre Georges François Leclerc
Dijon, France, 21000