Table 1.
Current clinical trials in women with breast cancer assessing the safety and/or efficacy of androgen receptor inhibition.
| NCT number | Title | Category | AR agent | Additional interventions | Phase |
|---|---|---|---|---|---|
| NCT03444025 | Neoadjuvant goserelin for triple-negative breast cancer | ADT | Goserelin | Chemotherapy | Phase 2 |
| NCT01352091 | Adjuvant AI combined with Zoladex | ADT | Goserelin | Anastrozole, tamoxifen | Phase 3 |
| NCT03878524 | A personalized medicine study for patients with advanced cancer of the breast, prostate, pancreas or those with refractory acute myelogenous leukemia | CYP17-lyase inhibitor/antiandrogen | Abiraterone/Enzalutamide | Abiraterone, enzalutamide, venetoclax, palbociclib, all-trans retinoic acid, bortezomib, cabazitaxel, oxaliplatin, fluorouracil, folinic acid, carboplatin, panobinostat, vorinostat, pembrolizumab, bevacizumab, ipilimumab, nivolumab, everolimus, sirolimus, celecoxib, olaparib, afatinib, cabozantinib, sorafenib, dasatinib, erlotinib, idelalisib, imatinib, lenvatinib, pertuzumab, ponatinib, ruxolitinib, sunitinib, trametinib, vemurafenib | Phase 1 |
| NCT03090165 | Ribociclib and bicalutamide in AR+ TNBC | Antiandrogen | Bicalutamide | Ribociclib | Phase 1/2 |
| NCT02353988 | AR-inhibitor bicalutamide in treating patients with TNBC | Antiandrogen | Bicalutamide | Physician’s choice | Phase 2 |
| NCT03650894 | Nivolumab, Ipilimumab, and bicalutamide in human epidermal growth factor (HER) 2 negative breast cancer patients | Antiandrogen | Bicalutamide | Nivolumab, ipilimumab | Phase 2 |
| NCT02299999 | SAFIR02_Breast—Efficacy of genome analysis as a therapeutic decision tool for patients with metastatic breast cancer | Antiandrogen | Bicalutamide | Targeted therapies, chemotherapy | Phase 2 |
| NCT03055312 | Bicalutamide in treatment of androgen receptor (AR) positive metastatic triple-negative breast cancer | Antiandrogen | Bicalutamide | TPC chemotherapy | Phase 3 |
| NCT03383679 | Study on androgen receptor and triple-negative breast cancer | Antiandrogen | Darolutamide | Capecitabine | Phase 2 |
| NCT03207529 | Alpelisib and enzalutamide in treating patients with androgen receptor and PTEN positive metastatic breast cancer | Antiandrogen | Enzalutamide | Alpelisib | Phase 1 |
| NCT02689427 | Enzalutamide and paclitaxel before surgery in treating patients with stage I–III androgen receptor-positive triple-negative breast cancer | Antiandrogen | Enzalutamide | Paclitaxel, surgery | Phase 2 |
| NCT02953860 | Fulvestrant plus enzalutamide in ER+/Her2− advanced breast cancer | Antiandrogen | Enzalutamide | Fulvestrant | Phase 2 |
| NCT02955394 | Preoperative fulvestrant with or without enzalutamide in ER+/Her2− breast cancer | Antiandrogen | Enzalutamide | Fulvestrant | Phase 2 |
| NCT02676986 | Short-term preoperative treatment with enzalutamide, alone or in combination with exemestane in primary breast cancer | Antiandrogen | Enzalutamide | Exemestane | Phase 2 |
| NCT00755885 | Abiraterone acetate in treating postmenopausal women with advanced or metastatic breast cancer | CYP17-lyase inhibitor | Abiraterone acetate | Phase 1/2 | |
| NCT01990209 | Orteronel as monotherapy in patients with metastatic breast cancer (MBC) that expresses the androgen receptor (AR) | CYP17-lyase inhibitor | Orteronel | Phase 2 | |
| NCT01616758 | Phase II study of GTx024 in women with metastatic breast cancer | SARM | Enobosarm | Phase 2 | |
| NCT02463032 | Efficacy and safety of GTx-024 in patients with ER+/AR+ breast cancer | SARM | Enobosarm | Phase 2 | |
| NCT02144051 | Phase I open label dose escalation study to investigate the safety and pharmacokinetics of AZD5312 in patients with androgen receptor tumors | Antisense oligonucleotides | AZD5312 | Phase 1 |