Table 1.
Ongoing studies testing AR-directed therapies in breast cancer. Abi, abiraterone; Enza, enzalutamide; AR, androgen receptor; AE, adverse event; MTD, maximum tolerated dose; CR, complete response; PR, partial response; and SD, stable disease.
| Indication | Therapeutic Agent(s) | Disease State | Study Phase | Sample Size | Primary Endpoint | NCT Number |
|---|---|---|---|---|---|---|
| Breast cancer | Enza, enza + anastrozole, enza + exemestane, enza + fulvestrant | Advanced | Phase I | 101 | Safety | NCT01597193 |
| Breast cancer | Enza + exemestane | Advanced | Phase II | 247 | Progression free survival | NCT02007512 |
| Triple-negative breast cancer | Enza + paclitaxel vs. placebo + paclitaxel | Advanced | Phase III | 780 | Progression free survival | NCT02929576 |
| AR positive, triple-negative breast cancer | Enza + taselisib | Advanced | Phase I/II | 73 | MTD | NCT02457910 |
| AR positive, triple-negative breast cancer | Enza + paclitaxel | Localized (neoadjuvant) | Phase II | 37 | Pathologic complete response and minimal residual disease | NCT02689427 |
| HER2 positive and AR positive breast cancer | Enza + trastuzumab | Advanced | Phase II | 80 | Clinical benefit rate: combined CR, PR and SD | NCT02091960 |
| AR positive, triple-negative breast cancer | Enza | Localized (adjuvant) | Phase II | 200 | Treatment discontinuation rate | NCT02750358 |
| AR positive, triple-negative breast cancer | Enza | Advanced | Phase II | 118 | Clinical benefit rate: combined CR, PR and SD | NCT01889238 |
| Breast cancer | VT-464 | Advanced | Phase I/II | 110 | MTD | NCT02580448 |
| Breast cancer | Abi | Advanced | Phase I/II | 74 | MTD, causality of AEs, and clinical benefit rate: combined CR, PR and SD | NCT00755885 |
| ER positive HER2 negative breast cancer | Abi | Advanced | Phase II | 299 | Progression free survival | NCT01381874 |
| HER2 negative breast cancer | Abi | Advanced | Phase II | 31 | Clinical benefit rate: combined CR, PR and SD | NCT01842321 |
| ER positive HER2 negative breast cancer | Abi vs. anastrozole | Localized (neoadjuvant) | Phase II | -- | Gene expression differences | NCT01814865 |
| AR positive breast cancer | Orteronel | Advanced | Phase II | 86 | Response rate: complete and partial responses | NCT01990209 |
| Breast cancer | Orteronel | Advanced | Phase I | 8 | Safety, recommended Phase II dose, and decrease in estradiol levels | NCT01808040 |