Table 1 Ongoing trials on anti-androgen treatment in breast cancer
Study | Status | Estimated Enrollment | Condition | Intervention | Primary Endpoint |
|---|---|---|---|---|---|
NCT00468715 (Phase II) non-randomized | Active, not recruiting | 28 | AR+/HR- MBC | • Bicalutamide | CBRa (observed CBR of 19% [22]) |
NCT01889238 (Phase II) non-randomized | Active, not recruiting | 118 | AR+/ triple negative ABC | • Enzalutamide | CBR (observed CBR of 25% [24]) |
ENDEAR trial NCT02929576 (Phase III) | withdrawn | 780 | Triple negative ABC | • Enzalutamide vs • Paclitaxel vs • combination | PFS |
NCT02750358 (phase II) non-randomized, single agent | Active, not recruiting | 200 | AR+ / triple negative ESBC | • Enzalutamide | treatment discontinuation rate/ feasibility |
NCT02689427 (phase IIb) non-randomized | recruiting | 37 | AR+ / triple negative ESBC | • Enzalutamide plus Paclitaxel in neoadjuvant setting | PCR rate |
NCT02007512 (phase II) randomized | Active, not recruiting | 247 | HR+ HER2- ABC | • Exemestan +/− Enzalutamide | PFS |
NCT02463032 (Phase II) randomized | Active, not recruiting | 88 | ER+/AR+ ABC | • GTx-024 (Enobosarm) • SARM • 9 vs. 18 mg. | CBR |
NCT01990209 (phase II) non- randomized | Active, not recruiting | 86 | HR+/AR+ or triple negative /AR+ MBC | • TAK-700 (orteronel) a nonsteroidal inhibitor of CYP17A1 | RRb DCRc |
NCT02067741 SAKK21/12 (Phase II) non- randomized | active, not recruiting | 90 | HR+/HER2- or triple negative/ AR+ ABC | • transdermal CR1447 (4-OH-testosterone) | DCR |
NCT02091960 (Phase II) non- randomized | Active, not recruiting | 103 | HER2 + /AR + ABC | • Enzalutamide + trastuzumab | CBR |