Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT03876951
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03876951
Study Brief:
Protocol Section:
NCT03876951