Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ - HORNEO 01

INSTITUT DE CANCEROLOGIE DE L'OUEST0 个研究点目标入组 262 人开始时间: 2020年10月12日最近更新: 2024年1月8日

试验速览

暂无简介。

•1) Elderly 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) CCIS 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 202

•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.

发起方

INSTITUT DE CANCEROLOGIE DE L'OUEST