Table 1.

Androgen blockade-based clinical studies in breast cancer.

Identifier	Study Design	Class of Agents	Agents	Molecular Profile	Patients (n)	Endpoint	Status of Trial
NCT02463032	Randomized, Open label Phase II	Selective-AR modulator	GTx-024	ER+ AR+ BC	88	CBR	Ongoing
NCT00468715	Open label Phase II	AR inhibitor	Bicalutamide	Metastatic TNBC	28	CR or PR	Ongoing
NCT02091960	Open label Phase II	AR inhibitor HER 2 Inhibitor	Enzalutamide Transtuzumab	HER2+ AR+ metastatic or locally advanced BC.	103	CBR	Ongoing
NCT00755885	Non randomized Open label Phase I/II	AR inhibitor	Abiraterone Acetate	Advanced or Metastatic AR+ BC	77	MTD CBR	Completed
NCT01842321	Single Group Assignment Open label Phase II	AR inhibitor	Abiraterone Acetate	Advanced or Metastatic TNBC	31	CBR	Ongoing
NCT02580448	Non randomized Open label Phase I/II	Lyase-selective CYP17 inhibitor	Seviteronel	Advanced TNBC, ER+ BC	175	CBR	Completed
NCT02689427	Non randomized Open label Phase IIB	AR Inhibitor Microtubule stabilizer	Enzalutamide Paclitaxel	AR+ TNBC Stage I-III	37	pCR RCB-I	Recruiting
NCT00004205	Randomized, double-blind-phase-III	Aromatase inhibitor Selective ER modulator	Letrozole Tamoxifen	ER+ PgR+ BC	8028	DFS	Completed

Abbreviations: MBC—metastatic breast cancer; CBR—clinical benefit rate; CR or PR—response rate; MTD—maximum tolerated dose; pCR—pathologic complete response; PFS—progress free survival; RCB-I—minimal residual disease; AR+—AR-positive.