Informations générales (source: ClinicalTrials.gov)
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) (NeoVAB)
Interventional
N/A
Centre Georges Francois Leclerc (Voir sur ClinicalTrials)
août 2019
avril 2025
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:24 | Contacter | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/12/2024 12:44:05 | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
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.
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