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