Table 4.
Phase II and III oral SERD trials in early ER positive breast cancer
| Trial | SERD | Phase | N | Investigational Arm | Comparator Arm | Population | Randomization | Duration of Intervention | Primary Endpoint | Design | ClinicalTrials.gov |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Adjuvant | |||||||||||
| AMEERA-692 | Amcenestrant | III | 3738 | Amcenestrant 200mgb | Tamoxifenb | Stage IIB/III, toxicity after≥6 months of (neo)adjuvant AI; includes HER2+ patients | 1:1 | 5 years | Invasive breast cancer free survival | Double-blind, placebo controlled | NCT05128773 |
| lidERA | Giredestrant | III | 4100 | Giredestrant 30mgb | Physician’s choice ET (Tamoxifen/ anastrozole/ letrozole/ exemestane)b | Med-High risk stage I-IIIc | 1:1 | 5 years | Invasive disease free survival | Open-label | NCT04961996 |
| Window/ Neoadjuvant | |||||||||||
| AMEERA-478 | Amcenestrant | II | 105a | Amcenestrant 200mg/400mg | Letrozole | Stage I-III post-menopausal | 1:1:1 | 2 weeks | ΔKi67 | Open-label | NCT04191382 |
| Giredestrant | I | 75 a | Giredestrant 3 dose levels | - | Stage I-III post-menopausal | - | 2 weeks | ΔKi67 | Open-label, single-arm | NCT03916744 | |
| coopERA76 | Giredestrant | II | 221 a | Giredestrant 30mg + Palbociclib (window giredestrant only) | Anastrozole + Palbociclib (window anastrozole only) | Stage I-III post-menopausal | 1:1 | 2 weeks (window) 16 weeks (neoadjuvant) | ΔKi67 | Open-label | NCT04436744 |
| SERENA-3 | Camizestrant | II | 92 | Camizestrant 75/150mg | - | Stage I-III post-menopausal | 1:1 | 5–7 days | ΔER expression | Open-label | NCT04588298 |
| EMBER-2 | Imlunestrant | I | 90 | Imlunestrant 3 dose levels | - | Stage I-III post-menopausal | - | NR | ΔER expression | Open-label | NCT04647487 |
| I-SPY2 EOP93 | Amcenestrant | II | 120 | Amcenestrant 200mg vs amcenestrant 200mg + abemaciclib vs amcenestrant 200mg + letrozoleb | - | Stage II/III, ≥2.5cm primary tumour; MammaPrint low-risk, or high-risk and cN0 | 1:1:1 | 6 months | Feasibility:≥75% patients completing ≥75% study therapy | Open-label | NCT01042379 |
| ELIPSE | Elacestrant | 0 | 24 | Elacestrant 400mg | - | Tumor ≥1.5cm, cN0, and Ki67 ≥10% | - | 4 weeks | Rate of complete cell cycle arrest (Ki67≤ 2.7%) | Open-label, single-arm | NCT04797728 |
Notes: aRecruitment completed. bAlso with luteinizing hormone releasing hormone agonist if male/premenopausal/peri-menopausal. cMedium-High risk defined as T4 and any pN stage; any T stage with ≥ pN1; pN0 with primary tumor >1cm and at least one of the following: grade 3, Ki67 ≥ 20%, Oncotype Dx® ≥ 26, High-Risk MammaPrint; patients who have had neoadjuvant chemotherapy must have residual disease in lymph nodes to be eligible.
Abbreviations: AI, aromatase inhibitor; ET, endocrine therapy; N, target enrolment; NR, not reported; SERD, selective estrogen receptor degrader.