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Table 1 Ongoing trials on anti-androgen treatment in breast cancer

From: Determination of the androgen receptor status of circulating tumour cells in metastatic breast cancer patients

StudyStatusEstimated EnrollmentConditionInterventionPrimary Endpoint
 NCT00468715 (Phase II) non-randomizedActive, not recruiting28AR+/HR- MBC• BicalutamideCBRa (observed CBR of 19% [22])
 NCT01889238 (Phase II) non-randomizedActive, not recruiting118AR+/ triple negative ABC• EnzalutamideCBR (observed CBR of 25% [24])
 ENDEAR trial NCT02929576 (Phase III)withdrawn780Triple negative ABC• Enzalutamide vs
• Paclitaxel vs
• combination
PFS
 NCT02750358 (phase II) non-randomized, single agentActive, not recruiting200AR+ / triple negative ESBC• Enzalutamidetreatment discontinuation rate/ feasibility
 NCT02689427 (phase IIb) non-randomizedrecruiting37AR+ / triple negative ESBC• Enzalutamide plus Paclitaxel in neoadjuvant settingPCR rate
 NCT02007512 (phase II) randomizedActive, not recruiting247HR+ HER2- ABC• Exemestan +/− EnzalutamidePFS
 NCT02463032 (Phase II) randomizedActive, not recruiting88ER+/AR+ ABC• GTx-024 (Enobosarm)
• SARM
• 9 vs. 18 mg.
CBR
 NCT01990209 (phase II) non- randomizedActive, not recruiting86HR+/AR+ or triple negative /AR+ MBC• TAK-700 (orteronel) a nonsteroidal inhibitor of CYP17A1RRb
DCRc
 NCT02067741 SAKK21/12
(Phase II) non- randomized
active, not recruiting90HR+/HER2- or triple negative/ AR+ ABC• transdermal CR1447 (4-OH-testosterone)DCR
 NCT02091960 (Phase II) non- randomizedActive, not recruiting103HER2 + /AR + ABC• Enzalutamide + trastuzumabCBR
  1. AR androgen receptor, ER oestrogen receptor, PR progesteron receptor, HR hormone receptor, HER2 human epidermal growth factor receptor 2:, CBR Clinical benefit rate, a defined as proportion of patients with stability, partial response and complete response assessed by RECIST v1.1 criteria, PFS progression free survival, ESBC early stage breast cancer, SARM selective androgen receptor modulator, ABC advanced breast cancer (metastatic or locally advanced), RR responder rate, b defined as the percentage of complete and partial responders (CR + PR) assessed by RECIST v1.1 criteria, DCR disease control rate, c defined as the percentage of patients who do not exhibit progression