protocolSection identificationModule nctId: NCT06365788, orgStudyIdInfo id: S66466, secondaryIdInfos id: 2022-502272-23-00, type: OTHER, domain: EU CT Number, briefTitle: Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer, acronym: ABBICAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Kom Op Tegen Kanker, collaborators name: Eli Lilly and Company, collaborators name: Teva Pharma, descriptionModule briefSummary: This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer., conditionsModule conditions: Triple Negative Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 53, type: ESTIMATED, armsInterventionsModule interventions name: Abemaciclib, interventions name: Bicalutamide, outcomesModule primaryOutcomes measure: Number of participants with disease control at 16 weeks, secondaryOutcomes measure: Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, secondaryOutcomes measure: HRQoL change from baseline as measured by EORTC QLQ-C30, secondaryOutcomes measure: Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells., secondaryOutcomes measure: Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate, secondaryOutcomes measure: Number of participants with disease control at 24 weeks, secondaryOutcomes measure: Number of participants with partial or complete response at 16 weeks, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Months of progression free survival, secondaryOutcomes measure: Months of overall survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Antwerp University Hospital, status: NOT_YET_RECRUITING, city: Antwerp, country: Belgium, contacts name: Sevilay Altintas, MD, PhD, role: CONTACT, phone: +3238213250, email: sevilay.altintas@uza.be, contacts name: Sevilay Altintas, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: Gasthuiszusters Antwerpen, status: NOT_YET_RECRUITING, city: Antwerp, country: Belgium, contacts name: Kevin Punie, MD, role: CONTACT, phone: +3234433737, email: kevin.punie@gza.be, contacts name: Kevin Punie, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.21989, lon: 4.40346, locations facility: University Hospital Brussels, status: NOT_YET_RECRUITING, city: Brussel, country: Belgium, contacts name: Christel Fontaine, MD, role: CONTACT, phone: +3224776040, email: christel.fontaine@uzbrussel.be, contacts name: Christel Fontaine, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: Ghent University Hospital, status: NOT_YET_RECRUITING, city: Ghent, country: Belgium, contacts name: Hannelore Denys, MD, PhD, role: CONTACT, phone: +3293322692, email: hannelore.denys@uzgent.be, contacts name: Hannelore Denys, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: Jessa Ziekenhuis, status: NOT_YET_RECRUITING, city: Hasselt, country: Belgium, contacts name: Annelies Requilé, MD, role: CONTACT, phone: +3211337979, email: annelies.requile@jessazh.be, contacts name: Annelies Requilé, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.93106, lon: 5.33781, locations facility: University Hospitals Leuven, status: RECRUITING, city: Leuven, country: Belgium, contacts name: Patrick Neven, MD, PhD, role: CONTACT, phone: +3216344750, email: patrick.neven@uzleuven.be, contacts name: Kristien Borremans, MD, role: CONTACT, phone: +3216347795, email: kristien.borremans@kuleuven.be, contacts name: Patrick Neven, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False