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Association details:
| Biomarker: | ER positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | Orserdu (elacestrant) (Selective estrogen receptor degrader) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: Updated results by duration of prior CDK4/6i in metastatic setting
Published date:
11/22/2022
Excerpt:
EMERALD (NCT03778931) is a randomized, open-label, phase 3 trial that enrolled pts with ER+/HER2- MBC ....Patients were randomized 1:1 to elacestrant (400 mg orally daily) or SoC....Updated PFS results show statistically significant results in favor of elacestrant, both in all pts and in pts with ESR1-mut....Elacestrant demonstrated longer PFS versus SOC that was positively associated with the duration of prior treatment with CDK4/6i, which was more pronounced in pts with ESR1-mut MBC. In this 2nd and 3rd line setting, elacestrant was well tolerated with significantly longer PFS versus SoC, highlighting its potential role as a therapeutic option for pts with ER+/HER2- MBC.
Trial ID:
Source:
Title:
220P - Elacestrant vs fulvestrant or aromatase inhibitor (AI) in phase III trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), vs standard of care (SOC) endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC): Subgroup analysis from EMERALD
Published date:
09/05/2022
Excerpt:
Treatment with elacestrant was associated with prolonged PFS at 6, 12, 15, and 18 months compared to fulvestrant or AI in both the overall population and pts with mESR1...Among pts with ER+/HER2− mBC, elacestrant prolonged PFS compared to both fulvestrant as well as AI, highlighting superior efficacy regardless of type of endocrine therapy.
Trial ID:
Source:
Title:
Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
Published date:
08/11/2022
Excerpt:
The Menarini Group...and Stemline Therapeutics (“Stemline”)...announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. The FDA has granted the application Priority Review...EMERALD met both of its pre-specified primary endpoints of progression-free survival (PFS) in the overall population and in patients with the ESR1 mutation (mESR1)...
Trial ID:
Source:
Title:
Subgroup analysis of patients with no prior chemotherapy in EMERALD: A phase 3 trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), versus investigator’s choice of endocrine monotherapy for ER+/HER2-advanced/metastatic breast cancer (mBC)
Published date:
05/26/2022
Excerpt:
Among patients without prior chemotherapy, treatment with elacestrant was associated with significantly prolonged PFS compared to SOC in both the overall population (hazard ratio [HR] = 0.68 [95% CI, 0.52-0.89] P = 0.004; median PFS 3.7 vs 2.0; 6-mo PFS 38% vs 23%; 12-mo PFS 27% vs 12%), and patients with mESR1 (HR = 0.54 [95% CI, 0.36-0.80] P = 0.002; median PFS 5.3 vs 1.9; 6-mo PFS 44% vs 24%; 12-mo PFS 31% vs 12%). Among patients with ER+/HER2− mBC without prior chemotherapy, elacestrant significantly prolonged PFS compared to SOC endocrine therapy and showed favorable outcomes in this subgroup.
DOI:
10.1200/JCO.2022.40.16_suppl.1100
Trial ID:
Source:
Title:
Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial
Published date:
05/18/2022
Excerpt:
PFS was prolonged in all patients (hazard ratio = 0.70; 95% CI, 0.55 to 0.88; P = .002) and patients with ESR1 mutation (hazard ratio = 0.55; 95% CI, 0.39 to 0.77; P = .0005)....Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer.
DOI:
10.1200/JCO.22.00338
Trial ID:
Source:
Title:
Novel SERD Has PFS Edge against Breast Cancer
Published date:
12/14/2021
Excerpt:
In the phase III EMERALD trial, the investigational oral selective estrogen receptor degrader elacestrant offered a modest but statistically significant improvement in progression-free survival in patients with ER-positive/HER2-negative breast cancer previously treated with endocrine therapy and a CDK4/6 inhibitor.
DOI:
10.1158/2159-8290.CD-NB2021-0406
Trial ID:
Source:
Title:
Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer
Published date:
10/20/2021
Excerpt:
The study was designed to evaluate elacestrant as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC)…EMERALD met both primary endpoints, showing statistically significant PFS in the overall population...
Trial ID:
Source:
Title:
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
Excerpt:
...- Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer....
Trial ID:
Source:
Title:
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer
Excerpt:
...ER-positive with expression higher than 10% and HER2-negative tumor...
Trial ID:
More C2 evidence
Source:
Title:
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
Excerpt:
...- Female or male patients with histologically confirmed ER positive (regardless of PR), HER2 negative breast cancer, according to local pathologist:...
Trial ID:
Source:
Title:
This study has 2 phases: a Phase 1b evaluation of elacestrant in combination with abemaciclib followed by a randomized Phase 2 evaluation of elacestrant alone or in combination with abemaciclib in women and men with brain metastases from ER positive, HER-2 negative breast cancer. Este estudio tiene 2 fases: una evaluación de Fase 1b de elacestrant en combinación con abemaciclib seguida de una evaluación randomizada de Fase 2 de elacestrant solo o en combinación con abemaciclib en mujeres y hombres con metástasis cerebrales causadas por un cáncer de mama con receptores de estrógeno y HER-2 negativo.
Excerpt:
...Patient must have ER positive, HER-2 negative tumor status as confirmed by local laboratory testing either from a fresh biopsy or from an archival tissue obtained no more than 2 years prior to signing of the informed consent form. ...
Trial ID:
Source:
Title:
Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer
Excerpt:
...Patient must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing either from a fresh biopsy or from an archival tissue obtained...
Trial ID:
Less C2 evidence
Source:
Title:
PD13-01 Elacestrant in postmenopausal women with estrogen receptor positive and HER2-negative early breast cancer: primary efficacy and safety analysis of the preoperative, window of opportunity SOLTI-1905-ELIPSE trial
Published date:
11/22/2022
Excerpt:
In untreated ER+/HER2-negative early BC a short-course preoperative treatment with elacestrant was associated with relevant biological and molecular response and with manageable safety profile.
Trial ID:
