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Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Study acronym: ABBICAR
StatusRecruiting
PhasePhase 2
Started2024-04-08
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
minor
Study Status, Eligibility v6
Eligibility criteria-170 characters
[...] upper limit for prior treatment lines in advanced setting. Patients with 1-10% cells with positive IHC for ER in the last recurrent/metastatic site must be treated with at least one line of endocrine therapy in advanced setting. Patients with known germline BRCA1/2 pathogenic variants sho [...]
2025-08-27
minor
Study Status, Contacts/Locations v5
Study sites6 entries, revised
GasthuiszustersZAS AntwerpenAugustinus
2025-07-29
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 6 sites
2025-06-30
minor
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+327 characters
[...] with at least 1 prior cytostatic regimen in advanced setting setting unless treatment with a cytostatic regimen is contraindicated as judged by Investigator. There is no upper limit for prior treatment lines in advan [...] Sodium or potassium outside normal reference range for site. Grade 1 abnormality of sodium and potassium (as defined by CTCAE v5.0) can be included if judged clinically not significant by the investigator, based on the participant's clinical context and comorbidities. Liver disease such as cirrhosis, chronic active hepatitis, o [...] mpaired lung function defined as spirometry and DLCO t [...]
Study sitesdetails revised at 1 of 6 sites
2025-05-05
minor
Study Identification, Study Status, Contacts/Locations v2
Study sitesdetails revised at 6 of 6 sites
2024-12-05
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v1
Completion date2027-12→2028-12
Eligibility criteria-53 characters
[...] of recurrent, unresectable, locally advanced, or metastatic androgenAR+ receptor (AR) positive Triple Negative Breast Carcinoma (TNBC) AR+ assessed locally and defined as ≥1% of cells staining on Immunohistochemistry (IHC) of last recurrent/metastatic breast cancer specimen Local b [...] ion of last recurrent/metastatic site with positive IHC for Estrogen Receptor (ER) and/or Progesterone Receptor (PR) in ≤10% of cells and negative for Human Epidermal growth factor Receptor 2 (HER2) per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP)-guidelines Prior invasive (metast [...] [...]
Study sitescontacts updated at 6 of 6 sites
2024-04-10
minor
Original filing
This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.
Trial Details
NCT Number NCT06365788
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: Kom Op Tegen Kanker, Eli Lilly and Company, Teva Pharma
Conditions Triple Negative Breast Neoplasms
Enrollment 53 participants
Start Date 2024-04-08
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-01