Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-14 @ 9:44 AM
Study NCT ID:
NCT07180693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Invasive-disease free survival (IDFS)', 'timeFrame': '3 years', 'description': 'Invasive disease-free survival (IDFS) will be defined as the time from surgery to invasive loco-regional recurrence, metastasis, other primary non-breast carcinomas, or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Distant relapse-free survival (DRFS)', 'timeFrame': '5 years', 'description': 'DRFS will be defined as the time from surgery to distant recurrence or death from any cause, whichever occurs first.'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': '5 years', 'description': 'PFS will be defined as the time from the disease recurrence to the date of documented disease progression or death from any cause, whichever occurs first.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '5 years', 'description': 'OS will be defined as the time from surgery to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adjuvant Therapy', 'CDK4/6 Inhibitor']}, 'descriptionModule': {'briefSummary': 'This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+/HER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.', 'detailedDescription': 'The study will also evaluate clinico-pathologic characteristics, patterns of recurrence, therapeutic choices and outcomes of the subgroup of patients relapsed during or within 12 months after adjuvant therapy with CDK4/6 inhibitors in combination with ET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with HR+/HER2- breast cancer who have received medical treatment in the neoadjuvant or adjuvant setting (chemotherapy, radiotherapy and hormonotherapy) and who have received or are scheduled to initiate adjuvant treatment with CDK4/6 inhibitors (abemaciclib or ribociclib) in combination with ET in the adjuvant setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female (regardless of menopausal status) or male ≥18 years of age;\n* The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4/6 inhibitors (abemaciclib or ribociclib);\n* ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO/CAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO/CAP recommendations;\n* Patients who are initiating or have initiated adjuvant treatment with a CDK4/6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Consent to data treatment according to the local regulation.\n\nExclusion Criteria:\n\n* Current participation in any other HR+/HER2- EBC study with any investigational products;\n* Patients who have already received adjuvant treatment with a CDK4/6 inhibitor as part of a clinical trial;\n* Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;\n* Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;\n* Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.'}, 'identificationModule': {'nctId': 'NCT07180693', 'acronym': 'BREAKER', 'briefTitle': 'Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors:', 'organization': {'class': 'OTHER', 'fullName': 'European Institute of Oncology'}, 'officialTitle': 'Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4/6 Inhibitors: Evaluation in the Real-world Setting', 'orgStudyIdInfo': {'id': 'UID 4879'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients undergoing treatment with CDK4/6 inhibitors'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Rita De Sanctis, MD', 'role': 'CONTACT', 'email': 'rdesanctis@asst-pg23.it', 'phone': '+39 035 267111'}, {'name': 'Rita De Sanctis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Marta Laganà, MD', 'role': 'CONTACT', 'email': 'marta.lagana@unibs.it', 'phone': '+39 030 3995410'}, {'name': 'Marta Laganà, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '72100', 'city': 'Brindisi', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Laura Orlando, MD', 'role': 'CONTACT', 'email': 'laura.orlando68@gmail.com', 'phone': '+39 0831 537111'}, {'name': 'Laura Orlando, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'P.O. Antonio Perrino - ASL Brindisi', 'geoPoint': {'lat': 40.63215, 'lon': 17.93607}}, {'zip': '26013', 'city': 'Crema', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Tomasello, MD', 'role': 'CONTACT', 'email': 'Gianluca.tomasello@asst-crema.it', 'phone': '+39 0373280730'}, {'name': 'Gianluca Tomasello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Ospedale Maggiore di Crema', 'geoPoint': {'lat': 45.36264, 'lon': 9.68176}}, {'zip': '23900', 'city': 'Lecco', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Crippa, MD', 'role': 'CONTACT', 'email': 'a.crippa@asst-lecco.it', 'phone': '+39 03 41253000'}, {'name': 'Alessandra Crippa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Lecco - PO Alessandro Manzoni', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'zip': '20025', 'city': 'Legnano', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Concetta Arcanà, MD', 'role': 'CONTACT', 'email': 'concetta.arcana@asst-ovestmi.it', 'phone': '+39 02 26433169'}, {'name': 'Concetta Arcanà, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asst Ovest Milanese', 'geoPoint': {'lat': 45.59788, 'lon': 8.91506}}, {'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Luca Licata, MD', 'role': 'CONTACT', 'email': 'licata.luca@hsr.it', 'phone': '+39 02 26433169'}, {'name': 'Luca Licata, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20133', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Francesca Ligorio, MD', 'role': 'CONTACT', 'email': 'francesca.ligorio@istitutotumori.mi.it', 'phone': '+39 0223903808'}, {'name': 'Francesca Ligorio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20141', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Nadia Bianco, MD', 'role': 'CONTACT', 'email': 'nadia.bianco@ieo.it', 'phone': '+39 02 94371977'}, {'name': 'Nadia Bianco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20157', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Maria Silvia Cona, MD', 'role': 'CONTACT', 'email': 'silvia.cona@asst-fbf-sacco.it', 'phone': '+39 02 39042493'}, {'name': 'Maria Silvia Cona, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PO Luigi Sacco - ASST Fatebenefratelli Sacco', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '41125', 'city': 'Modena', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Angela Toss, MD', 'role': 'CONTACT', 'email': 'angelatoss@unimore.it', 'phone': '+39 059 4222230'}, {'name': 'Angela Toss, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '20900', 'city': 'Monza', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Francesca Riva, MD', 'role': 'CONTACT', 'email': 'francesca.riva@irccs-sangerardo.it', 'phone': '+39 039 2339575'}, {'name': 'Francesca Riva, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Di Lauro, MD', 'role': 'CONTACT', 'email': 'vincenzo.dilauro@istitutotumori.na.it', 'phone': '+39 081 5903111'}, {'name': 'Vincenzo Di Lauro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione G. Pascale', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Barbara Tagliaferri, MD', 'role': 'CONTACT', 'email': 'barbara.tagliaferri@icsmaugeri.it', 'phone': '+39 03825921'}, {'name': 'Barbara Tagliaferri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICS Maugeri IRCCS', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Gianpiero Rizzo, MD', 'role': 'CONTACT', 'email': 'g.rizzo@smatteo.pv.it', 'phone': '+39 0382502094'}, {'name': 'Gianpiero Rizzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '42122', 'city': 'Reggio Emilia', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Laura Cortesi, MD', 'role': 'CONTACT', 'email': 'cortesilaura67@gmail.com', 'phone': '+39 0522335111'}, {'name': 'Laura Cortesi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda USL IRCCS di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00168', 'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Luisa Carbognin, MD', 'role': 'CONTACT', 'email': 'luisa.carbognin@policlinicogemelli.it', 'phone': '+39 06 30154953'}, {'name': 'Luisa Carbognin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00186', 'city': 'Roma', 'state': 'Italy', 'country': 'Italy', 'contacts': [{'name': 'Anna Cardillo, MD', 'role': 'CONTACT', 'email': 'anna.cardillo@fbf-isola.it', 'phone': '+39 066837697'}, {'name': 'Anna Cardillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Isola Tiberina - Gemelli Isola', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Nadia Bianco, MD', 'role': 'CONTACT', 'email': 'nadia.bianco@ieo.it', 'phone': '+39 02 94371977'}], 'overallOfficials': [{'name': 'Nadia Bianco, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}