Table 3.
Completed and ongoing trials in ER+/HER2-negative metastatic breast cancer with a focus on ESR1 mutational status and new selective estrogen receptor down-regulator (ClinicalTrials.gov accessed on 21 October 2019).
| Agent | Study Design | Estimated Enrollment | Primary Endpoint(s) | Status |
|---|---|---|---|---|
| AZD9496 (NCT02248090) | Phase I, open-label |
45 | Activity, tolerability, and safety of treatment | Completed |
| Tamoxifen (NCT030045653) | Phase I, open-label |
32 | CBR at 16 weeks | Completed |
| Basedoxifene (NCT02448771) | Phase Ib/II, open-label |
36 | CBR at 24 weeks | Active, not recruiting |
| Palbociclib plus AI/fulvestrant (NCT03079011) | Phase III, open-label |
800 | Safety until randomization/efficacy from randomization | Active, not recruiting |
| Elacestrant (NCT02338349) | Phase I, open-label |
57 | Dose-limiting toxicity | Active not recruiting |
| Elacestrant (NCT02650817) | Phase Ib, open-label |
16 | Effect of ER binding after elacestrant treatment | Active not recruiting |
| Elacestrant versus endocrine therapy (NCT03778931) | Phase III, open-label |
466 | PFS in patients with ESR1 mutations | Recruiting |
| SAR439859 as monotherapy or plus palbociclib (NCT03284957) | Phase I/II, open-label, non randomized |
224 | Safety and efficacy of SAR439859 as monotherapy and in combination with palbociciclib | Recruiting |
| SAR439859 (NCT04059484) | Phase II, open-label randomized |
282 | PFS | Recruiting |
Abbreviations: CBR, clinical benefit rate; PFS, progression free survival.