Table 2.
Ongoing Studies in Luminal Androgen Receptor Triple Negative Breast Cancer
| NCT (Study Name) | Study Phase | Study Treatment | Study Design | Population (Expected N) | Primary Outcome/ Secondary Outcomes | Preliminary Results |
|---|---|---|---|---|---|---|
| NCT04947189 (4CAST) | I/II | Docetaxel + Seviteronel | Single Arm, Open Label | AR+ mTNBC (65) | RPD2D/AE, ORR, DoR, OS | No |
| NCT02689427 | II | Paclitaxel + Enzalutamide (neoadjuvant) | Single Arm, Open Label | Stage I–III AR+ TNBC (37) | pCR, RCB, PFS | Yes |
| NCT05095207 | I/II | Abemaciclib + Bicalutamide | Single Arm, Open Label | AR+/HER2- mBC (60) | DLT/AE, CBR | Yes |
| NCT03090165 | I/II | Ribociclib + Bicalutamide | Single Arm, Open Label | AR+ advanced TNBC (37) | MTD (phase I), CBR (phase II)/PK, AE, CBR, ORR, DoR, PFS, OS | Yes |
| NCT03207529 | I | Alpelisib + Enzalutamide | Single Arm, Open Label | AR+/PTEN+ mBC (28) | MTD/AE, CBR, PFS | No |
| NCT04360941 (PAveMenT) | I | Palbociclib + Avelumab | Single Arm, Open Label | AR+ mTNBC (45) | MTD, ORR/CBR, PFS, AE | No |
| NCT03650894 | II | Nivolumab + Ipilimumab + Bicalutamide | Single Arm, Open Label | HER2- mBC* (138) | CBR (by iRECIST)/ORR, PFS, OS | No |
Note: *Patients with mTNBC must be AR+.
Abbreviations: AE, adverse events; AR, androgen receptor; BC, breast cancer; CBR, clinical benefit rate; DLT, dose-limiting toxicity; DoR, duration of response; HER2, human epidermal growth factor receptor 2; iRECIST, immune Response Evaluation Criteria in Solid Tumors; m, metastatic; MTD, maximum tolerated dose; N, number; ORR, objective response rate; OS, overall survival; pCR, pathological complete response; PFS, progression free survival; PK, pharmacokinetic; RCB, residual cancer burden; RP2D, recommended phase II dose; TNBC, triple negative breast cancer.