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

Primary Purpose

Ductal Carcinoma in Situ, Extensive Disease, Mastectomy

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tamoxifen 20 mg
Anastrozole 1Mg Tab
Sponsored by
Institut Cancerologie de l'Ouest
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

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

Arm Type

Experimental

Arm Label

Extended ductal carcinoma in situ with mastectomy indication

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy of neoadjuvant hormonotherapy
% of conservative surgeries performed after hormonotherapy

Secondary Outcome Measures

Disease-free survival (DFS)
DFS rates at 5 and 10 years post-surgery
Overall survival (OS)
Survival rates at 5 and 10 years post-surgery
Pathologic Complete Response (pCR)
Pathologic complete response is defined as no residual invasive cancer in the surgical specimen
Predictive factors of response
Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI
Quality of Life (Qol)
EORTC QLQ-C30 questionnaire
Quality of Life (Qol)
SF-36 questionnaire

Full Information

First Posted
December 2, 2020
Last Updated
April 21, 2022
Sponsor
Institut Cancerologie de l'Ouest
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1. Study Identification

Unique Protocol Identification Number
NCT04666961
Brief Title
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Acronym
HORNEO01
Official Title
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Cancerologie de l'Ouest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma in Situ, Extensive Disease, Mastectomy
Keywords
Neoadjuvant hormonotherapy, Tamoxifen, Anastrozole, conservative surgery, Breast cancer, extensive microcalcifications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients with extensive ductal carcinoma in situ with an indication for mastectomy receiving neoadjuvant hormone therapy with Tamoxifen (non-menopausal patients) or Anastrozole (postmenopausal patients)
Masking
None (Open Label)
Allocation
N/A
Enrollment
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extended ductal carcinoma in situ with mastectomy indication
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen 20 mg
Intervention Description
Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
Intervention Type
Drug
Intervention Name(s)
Anastrozole 1Mg Tab
Intervention Description
Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.
Primary Outcome Measure Information:
Title
Efficacy of neoadjuvant hormonotherapy
Description
% of conservative surgeries performed after hormonotherapy
Time Frame
6 months of hormonotherapy
Secondary Outcome Measure Information:
Title
Disease-free survival (DFS)
Description
DFS rates at 5 and 10 years post-surgery
Time Frame
5 and 10 years post-surgery
Title
Overall survival (OS)
Description
Survival rates at 5 and 10 years post-surgery
Time Frame
5 and 10 years post-surgery
Title
Pathologic Complete Response (pCR)
Description
Pathologic complete response is defined as no residual invasive cancer in the surgical specimen
Time Frame
6 months of hormonotherapy
Title
Predictive factors of response
Description
Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI
Time Frame
3 and 6 months of hormonotherapy
Title
Quality of Life (Qol)
Description
EORTC QLQ-C30 questionnaire
Time Frame
At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years
Title
Quality of Life (Qol)
Description
SF-36 questionnaire
Time Frame
At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoire BRILLAUD-MEFLAH, MD
Phone
0240679818
Ext
+33
Email
Victoire.brillaud-meflah@ico.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie DEBEAUPUIS
Phone
0240679844
Ext
+33
Email
emilie.debeaupuis@ico.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoire BRILLAUD-MEFLAH, MD
Organizational Affiliation
Institut de Cancérologie de l'Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICO - Site Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augustin P REYNARD, MD
Email
augustin.reynard@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sandrine HIRET, MD
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie AURIOL-LEIZAGOYEN, MD
Email
s.auriol@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Sophie AURIOL-LEIZAGOYEN, MD
Facility Name
Institut de cancérologie de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marian GUTOWSKI, MD
Email
marian.gutowski@icm.unicancer.fr
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie GOSSET, MD
Email
marie.gosset@nice.unicancer.fr
Facility Name
Institut Curie - Site de Paris
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enora LAAS, MD
Email
enora.laas@curie.fr
First Name & Middle Initial & Last Name & Degree
Enora LAAS, MD
Facility Name
Hopital Saint Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séverine ALRAN, MD
Email
Salran@hpsj.fr
First Name & Middle Initial & Last Name & Degree
Séverine ALRAN, MD
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoire BRILLAUD-MEFLAH, MD
Email
Victoire.brillaud-meflah@ico.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Victoire BRILLAUD-MEFLAH, MD
Facility Name
IUCT-O
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabrielle SELMES, MD
Email
selmes.gabrielle@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Gabrielle SELMES

12. IPD Sharing Statement

Learn more about this trial

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

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