Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Elacestrant · 1 trial · 4 indications
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...
Elacestrant is an investigational small molecule being studied for the treatment of ER-positive, HER2-negative breast cancer, specifically in patients with ctDNA relapse. It is currently in Phase 3 clinical development for this indication.
Elacestrant is a selective estrogen receptor degrader (SERD), a class of drugs that target the estrogen receptor. It is being studied in ER-positive breast cancer, where it aims to degrade the estrogen receptor to inhibit cancer cell growth.
Elacestrant is being developed by Natera, Inc. (NASDAQ: NTRA). The company is conducting a Phase 3 clinical trial of Elacestrant in patients with ER-positive, HER2-negative breast cancer.
Elacestrant is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is actively recruiting patients with ER-positive, HER2-negative breast cancer.
Elacestrant is being evaluated in the Phase 3 TREAT ctDNA trial (NCT05512364), which is recruiting 220 patients with ER-positive, HER2-negative breast cancer who have ctDNA relapse. The trial is active-controlled and enrolling participants across multiple European countries.