Table 2.
Completed and ongoing trials assessing the safety and efficacy and targeting androgen receptor in breast cancer
| NCT number | Title | BC subtype | AR agent drug class | Therapeutic agent | AR eligibility criteria | Menopausal status | Phase |
|---|---|---|---|---|---|---|---|
| NCT02463032 | Efficacy and safety of GTx024 in patients with ER+/AR+ breast cancer | ER+/AR+ | SARM | Enobosarm | Not Defined | Postmenopausal | Phase II |
| NCT02955394 | Preoperative Fulvestrant with or without Enzalutamide in ER+/HER2− breast cancer | ER+/HER2−/AR+ | Antiandrogen | Enzalutamide + Fulvestrant | Not Defined | Postmenopausal | Phase II |
| NCT02910050 | Bicalutamide plus aromatase inhibitors in ER+/AR+/HER2− metastatic breast cancer (BETTER) | ER+/HER2−/AR+ | Antiandrogen + AI | Bicalutamide + AI | Not Defined | Postmenopausal | Phase II |
| NCT01616758 | Phase II study of GTx024 in women with metastatic breast cancer | ER+ (any AR status) | SARM | Enobosarm | Not Defined | Postmenopausal | Phase II |
| NCT00755885 | Abiraterone acetate in treating postmenopausal women with advanced or metastatic breast cancer | AR+/ER− or ER+ (any AR status) | CYP17-lyase inhibitor | Abiraterone acetate | Not Defined | Postmenopausal | Phase I/II |
| NCT03207529 | Alpelisib and Enzalutamide in treating patients with AR and PTEN+ metastatic breast cancer | HER2−/PTEN+/AR+ | Antiandrogen | Enzalutamide + Alpelisib | ≥ 1% nuclear staining | All | Phase I* |
| NCT02580448 | CYP17-Lyase and AR inhibitor treatment with Seviteronel trial (CLARITY-01) | TNBC/AR+ or ER+/AR+ | CYP17-lyase inhibitor | Seviteronel | Not Defined | Postmenopausal (if ER+) | Phase I/II |
| NCT02676986 | Short-term preoperative treatment with Enzalutamide, alone or in combination with Exemestane in primary breast cancer (ARB) | ER+ and TNBC/AR+ | Antiandrogen | Enzalutamide + Exemestane | > 0% nuclear staining | Postmenopausal (if ER+) | Phase II |
| NCT01990209 | Orteronel as monotherapy in patients with metastatic breast cancer (MBC) that expresses AR | ER/PgR+/AR+ or TNBC/AR+ | CYP17-lyase inhibitor | Orteronel | > 10% IHC staining | Postmenopausal or Pre with Ovarian Suppression (if ER+) | Phase II |
| NCT02067741 | CR1447 in endocrine responsive-HER2- and TN-AR+ breast cancer | ER/PgR+ (HER2−) or TNBC/AR+ | Antiandrogen | CR1447 (4-OH-testosterone) | > 0% IHC staining | Postmenopausal | Phase II |
| NCT02091960 | A study to assess the efficacy and safety of enzalutamide with trastuzumab in patients with HER2+, AR+ metastatic or locally advanced BC | HER2+/AR+ | Antiandrogen | Enzalutamide + Trastuzumab | Not Defined | All | Phase II |
| NCT00468715 | Bicalutamide in treating patients with metastatic breast cancer | ER−/PgR−/AR+ | Antiandrogen | Bicalutamide | > 10% nuclear staining | All | Phase II |
| NCT03055312 | Bicalutamide in treatment of AR+ metastatic triple-negative breast cancer | TNBC/AR+ | Antiandrogen | Bicalutamide | IHC ≥ 10% | All | Phase III |
| NCT01889238 | Safety and efficacy study of enzalutamide in patients with advanced, AR+, triple-negative breast cancer | TNBC/AR+ | Antiandrogen | Enzalutamide | Not Defined | All | Phase II |
| NCT02457910 | Taselisib and Enzalutamide in treating patients with AR+ triple-negative metastatic breast cancer | TNBC/AR+ | Antiandrogen | Enzalutamide + Taselisib | ≥ 10% nuclear staining | All | Phase Ib/II |
| NCT02605486 | Palbociclib in combination with Bicalutamide for the treatment of AR+ metastatic breast cancer | TNBC/AR+ | Antiandrogen | Bicalutamide + Palbociclib | ≥ 1% nuclear staining | All | Phase I/II |
| NCT02971761 | Pembrolizumab and Enobosarm in treating patients with AR+ metastatic TNBC | TNBC/AR+ | SARM | Enobosarm + Pembrolizumab | ≥ 50% nuclear staining | All | Phase II |
| NCT03090165 | Ribociclib and Bicalutamide in AR+ TNBC | TNBC/AR+ | Antiandrogen | Bicalutamide + Ribociclib | > 0% IHC staining | All | Phase I/II |
| NCT02353988 | AR-inhibitor Bicalutamide in treating patients with TNBC (Arbre) | TNBC/AR+ | Antiandrogen | Bicalutamide | > 10% nuclear staining | All | Phase II |
| NCT02750358 | Feasibility study of adjuvant Enzalutamide for the treatment of early-stage AR+ triple-negative breast cancer | TNBC/AR+ | Antiandrogen | Enzalutamide | ≥ 1% nuclear staining | All | Phase II |
| NCT03383679 | Study on AR- and triple-negative breast cancer (START) | TNBC/AR+ | Antiandrogen | Darolutamide + Capecitabine | ≥ 10% IHC staining | All | Phase II |
| NCT02689427 | Enzalutamide and paclitaxel before surgery in treating patients with stage I–III AR+ triple-negative breast cancer | TNBC/AR+ | Antiandrogen | Enzalutamide + Paclitaxel | ≥ 10% nuclear staining | All | Phase II* |
| NCT05095207 | Abemaciclib in combination with Bicalutamide for androgen receptor-positive, HER2-negative metastatic breast cancer | HER2−/AR+ | Antiandrogen | Abemaciclib + Bicalutamide | ≥ 1% IHC staining | All | Phase Ib/II* |
| NCT04869943 | Efficacy evaluation of Enobosarm monotherapy in treatment of AR+/ER+/HER2− metastatic breast cancer (ARTEST) | ER+/HER2−/AR+ | SARM | Enobosarm | ≥ 40% nuclear staining | Postmenopausal or Pre with Ovarian Suppression | Phase III* |
| NCT05065411 | Efficacy and safety evaluation of Enobosarm in combo with Abemaciclib in treatment of ER+/HER2− metastatic breast cancer | ER+/HER2−/AR+ | SARM | Enobosarm + Abemaciclib | ≥ 40% nuclear staining | All | Phase III* |
| NCT03650894 | Nivolumab, Ipilimumab, and Bicalutamide in HER2− breast cancer patients | HER2−/AR+ | Antiandrogen | Nivolumab + Ipilimumab + Bicalutamide | Not Defined | All | Phase II* |
*Study is Actively Recruiting