Table 5.
First results with antiandrogen therapy in TNBC and studies in progress
| Study, ClinicalTrials.gov identifier | Phase, design | Drug | Primary outcome | Status | Results |
|---|---|---|---|---|---|
| Bicalutamide for the treatment of AR+, ER−, PR− metastatic BC patients70 NCT00468715 |
II Open-label Single-arm |
Bicalutamide 150 mg once daily | CBR at 6 months (CR, PR, stable disease) | Closed | 26 patients CBR 19% Median PFS 12 weeks |
| Clinical activity and safety of enzalutamide in patients with advanced, AR+ TNBC, stage 171 NCT01889238 |
II Open-label Single-arm |
Enzalutamide 160 mg once daily | CBR at 16 weeks (CR, PR, stable disease) | Not recruiting | 26 patients CBR16 42% |
| Clinical activity and safety of enzalutamide in patients with advanced, AR+ TNBC, stage 272 NCT01889238 |
II Open-label Single-arm |
Enzalutamide 160 mg once daily | CBR at 16 weeks (CR, PR, stable disease) | Not recruiting | 75 patients CBR16 35% Median PFS 14.7 weeks |
| Activity of abiraterone acetate plus prednisone in patients with a molecular apocrine HER2− locally advanced or metastatic BC NCT01842321 |
II Open-label Single-arm |
Abiraterone acetate 160 mg once daily | CBR at 6 months (CR, PR, stable disease) | Not recruiting | Not available |
| Orteronel as monotherapy in patients with metastatic BC that expresses the AR NCT01990209 |
II Open-label Single-arm |
Orteronel 300 mg twice daily | Response rate at 36 months Disease control rate at 36 months |
Recruiting | Not available |
| Bicalutamide as a treatment in AR-positive metastatic triple-negative breast cancer (mTNBC) patients NCT02348281 |
II Open-label Single-arm |
Bicalutamide 150 mg once daily | CBR | Recruiting | Not available |
| AR inhibitor bicalutamide in treating patients with TNBC NCT02353988 |
II Open-label Single-arm |
Bicalutamide 150 mg once daily | CBR | Recruiting | Not available |
| Efficacy and safety of GTx-024 in patients with AR+ TNBC NCT02368691 |
II Open-label Single-arm |
GTx-024 18 mg once daily | CBR | Recruiting | Not available |
| Safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of VT-464 in patients with advanced BC NCT02580448 |
I/II Open-label Single-arm |
VT-464 once daily | Phase I: maximum tolerated dose Phase II: CBR16 and CBR24 for patients with AR+ TNBC | Recruiting | Not available |
Abbreviations: BC, breast cancer; CBR, clinical benefit rate; CBR16, clinical benefit rate at 16; CBR24, clinical benefit rate at 24; CR, complete response; mTNBC, metastatic triple-negative breast cancer; PFS, progression-free survival; PR, partial response; TNBC, triple-negative breast cancer; AR, androgen receptor; ER, estrogen receptor; HER2, human epidermal growth factor receptor 2; PR-, progesterone receptor negative.