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2020年10月12日

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注册库

who.int

开始日期

2020年10月12日

结束日期

待定

最后更新

2年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

INSTITUT DE CANCEROLOGIE DE L'OUEST

•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

•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