Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ (HORNEO01)
Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
About this trial
This is an interventional treatment trial for Ductal Carcinoma in Situ focused on measuring Neoadjuvant hormonotherapy, Tamoxifen, Anastrozole, conservative surgery, Breast cancer, extensive microcalcifications
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 40 years old
- Histological diagnosis of ductal carcinoma in situ without infiltrating contingent
- Clinical T0N0
- Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status
- Indication for mastectomy
- DCIS visible on MRI performed with clip sequence
- Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.
- Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.
- Affiliated patient or beneficiary of the social security system.
Exclusion Criteria:
- Invasive breast carcinoma
- Lobular carcinoma in situ
- pN+ patient
- Indication for conservative surgery
- Contraindications to anastrozole or tamoxifen
- Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.
- Histologically proven multifocal lesion
- Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)
- History of homolateral breast cancer
- Ongoing contralateral breast cancer
- Known mutation BRCA1 BRCA2
- Other cancer in progress at inclusion
- Pregnant woman, or breastfeeding,
- Persons deprived of liberty or under guardianship or trusteeship,
- Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.
Sites / Locations
- ICO - Site Paul PapinRecruiting
- Institut BergonieRecruiting
- Institut de cancérologie de MontpellierRecruiting
- Centre Antoine LacassagneRecruiting
- Institut Curie - Site de Paris
- Hopital Saint JosephRecruiting
- Institut de Cancérologie de l'OuestRecruiting
- IUCT-ORecruiting
Arms of the Study
Arm 1
Experimental
Extended ductal carcinoma in situ with mastectomy indication
Patients receive 6 months of tamoxifen or anastrozole in a neoadjuvant situation. Tamoxifen and Anastrozole will be delivered in their original packaging at J0 and M3 : Tamoxifen: box of tablets dosed at 20 mg Anastrozole: box of tablets 1 mg. Tamoxifen will be initiated in premenopausal patients orally at a standard dose of 20mg/day as a single dose for 6 months. Anastrozole will be administered orally to postmenopausal patients at the standard dose of 1mg/day in a single dose for 6 months.