Clinical Trials Logo

Clinical Trial Summary

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.


Clinical Trial Description

This study is a phase II single arm clinical trial. Phase II clinical trials test the safety and effectiveness of an intervention to learn whether the intervention works in treating a specific disease. In this study, the investigators will include patients with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer. The participants need to be progressive after at least 1 prior cytostatic regimen in advanced setting. The participants will be treated with bicalutamide and abemaciclib. Bicalutamide works against the androgen receptor and abemaciclib stops the cell cycle. The investigators will look into if this combination can help patients with androgen receptor positive triple negative breast cancer. The investigators will also look into if this is a safe combination. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06365788
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact Patrick Neven, MD, PhD
Phone +3216344750
Email patrick.neven@uzleuven.be
Status Recruiting
Phase Phase 2
Start date April 8, 2024
Completion date December 2027

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Completed NCT02789332 - Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1
Recruiting NCT05208762 - A Study of SGN-PDL1V in Advanced Solid Tumors Phase 1
Completed NCT01969643 - A Safety Study of SGN-LIV1A in Breast Cancer Patients Phase 1
Terminated NCT04489940 - Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer Phase 2
Not yet recruiting NCT06154109 - Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial Phase 2
Withdrawn NCT02539017 - The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer Phase 2
Terminated NCT02720185 - Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR Phase 2
Completed NCT03092934 - A Study of AK-01 (LY3295668) in Solid Tumors Phase 1/Phase 2
Recruiting NCT04895709 - A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06380816 - A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer Phase 1/Phase 2
Active, not recruiting NCT03036488 - Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522) Phase 3
Recruiting NCT06385990 - Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy Phase 2
Recruiting NCT05252390 - NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT02685306 - A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer Phase 2
Active, not recruiting NCT04251533 - Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Phase 3