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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03870802
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Patient requiring a breast surgery (total mastectomy) of an early stage tumour classified as :
* Luminal A (Arm A) : Patients with a moderate risk of breast cancer progression or,
* Luminal B or Basal (Arm B) : Patients with a high risk of breast cancer progression
* Systemic treatment not initiated
* Breast cup size ≥ C
* Informed and signed consent.
Exclusion Criteria:
* Neo-adjuvant chemotherapy or hormonotherapy
* History of breast irradiation
* Pregnant or breastfeeding woman
* Patient under tutorship or curatorship
* Patient who underwent a lumpectomy with a level-2 oncoplastic surgery (ex: breast reduction with an inverted-T remodeling)
* Any other prior anti-tumor treatment
* Other medical pathology which may interfere with the biologic evaluation, especially chronic auto-immune diseases.
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03870802
Study Brief:
Protocol Section:
NCT03870802