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 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
NCT ID:
NCT04666961
Eligibility Criteria:
Inclusion Criteria:
1. Patient ≥ 40 years old
2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
3. Clinical T0N0
4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
5. Indication for mastectomy
6. DCIS visible on MRI performed with clip sequence
7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
9. Affiliated patient or beneficiary of the social security system.
Exclusion Criteria:
1. Invasive breast carcinoma
2. Lobular carcinoma in situ
3. pN+ patient
4. Indication for conservative surgery
5. Contraindications to anastrozole or tamoxifen
6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.
7. Histologically proven multifocal lesion
8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
9. History of homolateral breast cancer
10. Ongoing contralateral breast cancer
11. Known mutation BRCA1 BRCA2
12. Other cancer in progress at inclusion
13. Pregnant woman, or breastfeeding,
14. Persons deprived of liberty or under guardianship or trusteeship,
15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT04666961
Study Brief:
Protocol Section:
NCT04666961