Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05512364 | Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) | PHASE3 | RECRUITING | 220 | — | — | Dec 15, 2023 | Nov 1, 2035 | May 15, 2026 | 109 | Belgium, Cyprus +10 |
Distant metastasis free survival (DMFS) defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | elacestrant 400 mg/day orally once daily on a continuous dosing schedule |
| Control arm | ACTIVE_COMPARATOR | standard endocrine treatment - the same they were receiving at the time of ctDNA detection |
| Name | Type | Description |
|---|---|---|
| Elacestrant | DRUG | 400mg QD orally on a continuous dosing schedule |
| Tamoxifen | DRUG | 20 mg QD orally on a continuous dosing schedule |
| Letrozole 2.5mg | DRUG | 2.5 mg QD orally on a continuous dosing schedule |
| Anastrozole 1mg | DRUG | 1 mg QD orally on a continuous dosing schedule |
| Exemestane 25 MG | DRUG | 25 mg QD orally on a continuous dosing schedule |
Inclusion Criteria: 1. ctDNA screening phase: Main inclusion criteria: • Female (both pre- and postmenopausal) or male patients with histologically confirmed ER positive (regardless of PR), HER2 negative breast cancer, according to local pathologist: * ER-positive defined as ≥ 10% of...