Viewing Study NCT04666961



Ignite Creation Date: 2024-05-06 @ 3:32 PM
Last Modification Date: 2024-10-26 @ 1:51 PM
Study NCT ID: NCT04666961
Status: RECRUITING
Last Update Posted: 2022-04-22
First Post: 2020-12-02

Brief Title: Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Sponsor: Institut Cancerologie de lOuest
Organization: Institut Cancerologie de lOuest

Study Overview

Official Title: Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Status: RECRUITING
Status Verified Date: 2022-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HORNEO01
Brief Summary: Ductal carcinoma in situ DCIS accounts for approximately 20 of newly diagnosed breast cancer cases Of these women 20 require radical management in the form of mastectomy because of the extent of the lesions which most often manifest as diffuse microcalcifications

This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients

Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy

Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence

The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS
Detailed Description: Description of the modalities for recruiting

Following screening and discovery of a DCIS patients are referred to the center for surgical management

During a standard consultation the surgeon presents the study to the patient who has been diagnosed with extensive DCIS with an indication for mastectomy The surgeon provides the patient with the information note and the consent form to participate in the study Once the consent form is signed by the patient and the investigator the investigator prescribes a screening test to be performed within 30 days prior to the start of hormone therapy

Screening assessment includes

A clinical exam and a breast imaging exam mammography and breast and axillary ultrasound In case of a suspicious breast ultrasound image microbiopsy will be performed to eliminate an infiltrating component

One or more macrobiopsy Each biopsied site will be located using an X-ray clip inserted at the time of sample

A MRI post-macrobiopsy Research of estrogen receptor expression

Once the investigator has verified and validated all the eligibility criteria the patient will be included

Prescriptions for Tamoxifen non-menopausal patients or Anastrozole menopausal patients are given to patients and dispensed by the centers pharmacy

Monitoring during treatment

Patients will benefit from imaging monitoring Mammography - breast ultrasound - axillary ultrasound MRI at 3 months and 6 months during hormonotherapy

In case of progression observed during treatment hormone therapy will be stopped and you will then benefit from a mastectomy

Surgery

Mastectomy or tumorectomy will be performed according to the tumor response to hormone therapy observed on MRI

All patients will benefit sentinel node detection An additional axillary dissection will be performed based on the results of the sentinel node analysis

Analysis of biomarkers and tumor microenvironment before and after treatment on diagnostic macrobiopsies and on tumorectomy or mastectomy will be performed at Institut de Cancérologie de lOuest

Patients will be seen in postoperative consultation Adjuvant treatments or re-surgical interventions will be prescribed carried out and the patients will be followed up and examined at 6 months after surgery or at the end of adjuvant treatments and then annually for 10 years with control mammography

Patients who have had conservative surgery will have an MRI at 6 months from the end of radiotherapy

All patients will be asked to complete quality of life questionnaires at baseline 6 and 12 months post-surgery and annually for 9 years

EORTC QLQ-C30 up to 5 years only Short Form 36 Health Survey questionnaire

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None