Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ (HORNEO01)

April 21, 2022 updated by: Institut Cancerologie de l'Ouest

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 center's 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 l'Ouest.

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 Type

Interventional

Enrollment (Anticipated)

262

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49055
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonié
        • Contact:
        • Principal Investigator:
          • Sophie AURIOL-LEIZAGOYEN, MD
      • Montpellier, France, 34298
      • Nice, France, 06189
      • Paris, France, 75014
        • Recruiting
        • Hôpital Saint Joseph
        • Contact:
        • Principal Investigator:
          • Séverine ALRAN, MD
      • Paris, France, 75005
        • Not yet recruiting
        • Institut Curie - Site de Paris
        • Contact:
        • Principal Investigator:
          • Enora LAAS, MD
      • Saint Herblain, France, 44805
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Tamoxifen 20 mg
Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
Drug: Anastrozole 1Mg Tab
Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of neoadjuvant hormonotherapy
Time Frame: 6 months of hormonotherapy
% of conservative surgeries performed after hormonotherapy
6 months of hormonotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS)
Time Frame: 5 and 10 years post-surgery
DFS rates at 5 and 10 years post-surgery
5 and 10 years post-surgery
Overall survival (OS)
Time Frame: 5 and 10 years post-surgery
Survival rates at 5 and 10 years post-surgery
5 and 10 years post-surgery
Pathologic Complete Response (pCR)
Time Frame: 6 months of hormonotherapy
Pathologic complete response is defined as no residual invasive cancer in the surgical specimen
6 months of hormonotherapy
Predictive factors of response
Time Frame: 3 and 6 months of hormonotherapy
Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI
3 and 6 months of hormonotherapy
Quality of Life (Qol)
Time Frame: At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years
EORTC QLQ-C30 questionnaire
At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years
Quality of Life (Qol)
Time Frame: At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years
SF-36 questionnaire
At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Victoire BRILLAUD-MEFLAH, MD, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2033

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2020-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mastectomy

Clinical Trials on Tamoxifen 20 mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe