Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT04666961
Status:
RECRUITING
Last Update Posted:
2022-04-22
First Post:
2020-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 262}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2033-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of neoadjuvant hormonotherapy', 'timeFrame': '6 months of hormonotherapy', 'description': '% of conservative surgeries performed after hormonotherapy'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival (DFS)', 'timeFrame': '5 and 10 years post-surgery', 'description': 'DFS rates at 5 and 10 years post-surgery'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 and 10 years post-surgery', 'description': 'Survival rates at 5 and 10 years post-surgery'}, {'measure': 'Pathologic Complete Response (pCR)', 'timeFrame': '6 months of hormonotherapy', 'description': 'Pathologic complete response is defined as no residual invasive cancer in the surgical specimen'}, {'measure': 'Predictive factors of response', 'timeFrame': '3 and 6 months of hormonotherapy', 'description': 'Response is defined by the variation in the diameter of the longest dimension of the target lesion measured by MRI'}, {'measure': 'Quality of Life (Qol)', 'timeFrame': 'At baseline, at 6 months and 12 months post-surgery, and then each year for 4 years', 'description': 'EORTC QLQ-C30 questionnaire'}, {'measure': 'Quality of Life (Qol)', 'timeFrame': 'At baseline, at 6 months and 12 months post-surgery, and then each year for 9 years', 'description': 'SF-36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant hormonotherapy', 'Tamoxifen', 'Anastrozole', 'conservative surgery', 'Breast cancer', 'extensive microcalcifications'], 'conditions': ['Ductal Carcinoma in Situ', 'Extensive Disease', 'Mastectomy']}, 'descriptionModule': {'briefSummary': '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.\n\nThis mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients.\n\nNeoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy.\n\nAdjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence.\n\nThe 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.', 'detailedDescription': "Description of the modalities for recruiting :\n\nFollowing screening and discovery of a DCIS, patients are referred to the center for surgical management.\n\nDuring 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.\n\nScreening assessment includes :\n\nA 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.\n\nOne or more macrobiopsy. Each biopsied site will be located using an X-ray clip inserted at the time of sample.\n\nA MRI post-macrobiopsy. Research of estrogen receptor expression\n\nOnce the investigator has verified and validated all the eligibility criteria, the patient will be included.\n\nPrescriptions for Tamoxifen (non-menopausal patients) or Anastrozole (menopausal patients) are given to patients and dispensed by the center's pharmacy.\n\nMonitoring during treatment :\n\nPatients will benefit from imaging monitoring (Mammography, +/- breast ultrasound, +/- axillary ultrasound, MRI) at 3 months and 6 months during hormonotherapy.\n\nIn case of progression observed during treatment, hormone therapy will be stopped and you will then benefit from a mastectomy.\n\nSurgery :\n\nMastectomy or tumorectomy will be performed according to the tumor response to hormone therapy observed on MRI.\n\nAll patients will benefit sentinel node detection. An additional axillary dissection will be performed based on the results of the sentinel node analysis.\n\nAnalysis 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.\n\nPatients 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).\n\nPatients who have had conservative surgery will have an MRI at 6 months from the end of radiotherapy.\n\nAll patients will be asked to complete quality of life questionnaires at baseline, 6 and 12 months post-surgery, and annually for 9 years:\n\nEORTC QLQ-C30 (up to 5 years only), Short Form (36) Health Survey questionnaire."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient ≥ 40 years old\n2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent\n3. Clinical T0N0\n4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status\n5. Indication for mastectomy\n6. DCIS visible on MRI performed with clip sequence\n7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity.\n8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator.\n9. Affiliated patient or beneficiary of the social security system.\n\nExclusion Criteria:\n\n1. Invasive breast carcinoma\n2. Lobular carcinoma in situ\n3. pN+ patient\n4. Indication for conservative surgery\n5. Contraindications to anastrozole or tamoxifen\n6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6.\n7. Histologically proven multifocal lesion\n8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...)\n9. History of homolateral breast cancer\n10. Ongoing contralateral breast cancer\n11. Known mutation BRCA1 BRCA2\n12. Other cancer in progress at inclusion\n13. Pregnant woman, or breastfeeding,\n14. Persons deprived of liberty or under guardianship or trusteeship,\n15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons.'}, 'identificationModule': {'nctId': 'NCT04666961', 'acronym': 'HORNEO01', 'briefTitle': 'Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ', 'organization': {'class': 'OTHER', 'fullName': "Institut Cancerologie de l'Ouest"}, 'officialTitle': 'Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ', 'orgStudyIdInfo': {'id': 'ICO-2020-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Extended ductal carcinoma in situ with mastectomy indication', 'description': 'Patients receive 6 months of tamoxifen or anastrozole in a neoadjuvant situation.\n\nTamoxifen and Anastrozole will be delivered in their original packaging at J0 and M3 :\n\n* Tamoxifen: box of tablets dosed at 20 mg\n* 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.\n\nAnastrozole will be administered orally to postmenopausal patients at the standard dose of 1mg/day in a single dose for 6 months.', 'interventionNames': ['Drug: Tamoxifen 20 mg', 'Drug: Anastrozole 1Mg Tab']}], 'interventions': [{'name': 'Tamoxifen 20 mg', 'type': 'DRUG', 'description': 'Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.', 'armGroupLabels': ['Extended ductal carcinoma in situ with mastectomy indication']}, {'name': 'Anastrozole 1Mg Tab', 'type': 'DRUG', 'description': 'Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.', 'armGroupLabels': ['Extended ductal carcinoma in situ with mastectomy indication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49055', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Augustin P REYNARD, MD', 'role': 'CONTACT', 'email': 'augustin.reynard@ico.unicancer.fr'}, {'name': 'Sandrine HIRET, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICO - Site Paul Papin', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie AURIOL-LEIZAGOYEN, MD', 'role': 'CONTACT', 'email': 's.auriol@bordeaux.unicancer.fr'}, {'name': 'Sophie AURIOL-LEIZAGOYEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '34298', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marian GUTOWSKI, MD', 'role': 'CONTACT', 'email': 'marian.gutowski@icm.unicancer.fr'}], 'facility': 'Institut de cancérologie de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06189', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie GOSSET, MD', 'role': 'CONTACT', 'email': 'marie.gosset@nice.unicancer.fr'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Enora LAAS, MD', 'role': 'CONTACT', 'email': 'enora.laas@curie.fr'}, {'name': 'Enora LAAS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie - Site de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Séverine ALRAN, MD', 'role': 'CONTACT', 'email': 'Salran@hpsj.fr'}, {'name': 'Séverine ALRAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '44805', 'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Victoire BRILLAUD-MEFLAH, MD', 'role': 'CONTACT', 'email': 'Victoire.brillaud-meflah@ico.unicancer.fr'}, {'name': 'Victoire BRILLAUD-MEFLAH, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gabrielle SELMES, MD', 'role': 'CONTACT', 'email': 'selmes.gabrielle@iuct-oncopole.fr'}, {'name': 'Gabrielle SELMES', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IUCT-O', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Victoire BRILLAUD-MEFLAH, MD', 'role': 'CONTACT', 'email': 'Victoire.brillaud-meflah@ico.unicancer.fr', 'phone': '0240679818', 'phoneExt': '+33'}, {'name': 'Emilie DEBEAUPUIS', 'role': 'CONTACT', 'email': 'emilie.debeaupuis@ico.unicancer.fr', 'phone': '0240679844', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Victoire BRILLAUD-MEFLAH, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Institut de Cancérologie de l'Ouest"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut Cancerologie de l'Ouest", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}