Table 1.
Recently completed and recruiting clinical trials targeting androgen signaling in TNBC
| Trial ID | Agent(s) | Mechanism(s) of action | Patient population | Study design | Patients (n) | Primary end point(s) | Status |
|---|---|---|---|---|---|---|---|
| NCT00468715 | Bicalutamide | AR inhibitor | AR+/ER−/PR− metastatic breast cancer | Nonrandomized, open-label, Phase II | 26 | Clinical benefit rate | Results reported |
| NCT02353988 | Bicalutamide | AR inhibitor | AR+ metastatic TNBC | Randomized, open-label, Phase II | 60 estimated | Clinical benefit rate, progression-free survival | Not yet recruiting |
| NCT03055312 | Bicalutamide | AR inhibitor | AR+ metastatic TNBC | Randomized, open-label, Phase III | 262 estimated | Clinical benefit rate | Recruiting |
| NCT02605486 | Bicalutamide Palbociclib | AR inhibitor CDK4/CDK6 inhibitor | AR+ metastatic breast cancer | Nonrandomized, open-label, Phase I/II | 51 | Safety/tolerability, progression-free survival | Recruiting |
| NCT03090165 | Bicalutamide Ribociclib | AR inhibitor CDK4/CDK6 inhibitor | AR+ metastatic or locally advanced TNBC | Nonrandomized, open-label, Phase I/II | 58 estimated | Safety/tolerability, clinical benefit rate | Recruiting |
| NCT02750358 | Enzalutamide | AR inhibitor | AR+ TNBC, stage I–III breast cancer | Nonrandomized, open-label, Phase II | 200 estimated | 1-year dose compliance rate | Recruiting |
| NCT01889238 | Enzalutamide | AR inhibitor | AR+ advanced TNBC | Nonrandomized, open-label, Phase II | 118 | Clinical benefit rate | Completed |
| NCT02689427 | Enzalutamide Paclitaxel | AR inhibitor Microtubule stabilizer | AR+ TNBC, stage I–III breast cancer | Nonrandomized, open label, Phase IIB | 37 estimated | pCR, RCB-I | Recruiting |
| NCT02067741 | 4-OH-testosterone | AR and aromatase inhibitor | AR+ TNBC or ER+/PR+/HER2− or ER+/PR−/HER2− advanced breast cancer | Nonrandomized, open-label, Phase II | 90 estimated | Clinical benefit rate | Recruiting |
| NCT02144051 | AZD5312 | AR small molecule inhibitor | Solid carcinomas with AR pathway as potential factor | Nonrandomized, open-label, Phase I | 32 | Safety/tolerability | Completed |
| NCT02368691 | Enobosarm | Selective AR modulator | AR+ advanced TNBC | Nonrandomized, open-label, Phase II | 55 estimated | Clinical benefit rate | Recruiting |
| NCT02971761 | Enobosarm Pembrolizumab | Selective AR modulator Checkpoint inhibitor | AR+ metastatic TNBC | Nonrandomized, open-label, Phase II | 29 estimated | Safety/tolerability, ORR | Recruiting |
| NCT01884285 | Abiraterone acetate AZD8186 AZD2014 | CYP17 inhibitor PI3K inhibitor mTOR inhibitor | Advanced CRPC, SqNSCLC, advanced TNBC | Nonrandomized, open-label, Phase I | 180 estimated | Safety/tolerability | Recruiting |
| NCT00755885 | Abiraterone acetate | CYP17 inhibitor | Postmenopausal women with ER+ or AR+ metastatic or locally advanced breast cancer | Nonrandomized, open-label, Phase I/II | 77 | Safety/toxicity, clinical benefit rate | Completed |
| NCT01990209 | Orteronel | CYP17 inhibitor | AR+ metastatic breast cancer | Nonrandomized, open-label, Phase II | 86 estimated | Clinical benefit rate | Recruiting |
| NCT02130700 | Seviteronel | CYP17 inhibitor | AR+ metastatic TNBC | Nonrandomized, open-label, Phase II | 48 estimated | Clinical benefit rate | Recruiting |
| NCT02580448 | Seviteronel | CYP17 inhibitor | Advanced AR+ TNBC or ER+ breast cancer | Nonrandomized, open-label, Phase I/II | 110 estimated | Safety/tolerability, clinical benefit rate | Recruiting |
Abbreviations: CRPC, castrate-resistant prostate cancer; ORR, objective response rate; pCR, pathological complete response; RCB, residual cancer burden; SqNSCLC, squamous non-small-cell lung cancer; AR, androgen receptor; TNBC, triple-negative breast cancer; CDK, cyclin-dependent kinase; CYP17, cytochrome P450 17α-hydroxylase/17,20-lyase; mTOR, mechanistic target of rapamycin; P13K, phosphatidylinositol-3-kinase; ER, estrogen receptor; PR, progesterone receptor; HER, human epidermal growth factor.