Elacestrant for Breast Cancer
(ELCIN Trial)
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stemline Therapeutics, Inc.
Must be taking: LHRH agonists
Must not be taking: CDK4/6 inhibitors, Chemotherapy
Disqualifiers: CNS metastases, Visceral crisis, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.
Do I need to stop my current medications to join the trial?
The trial requires stopping certain medications before starting. You must stop any endocrine therapy at least 14 days before the first dose and avoid certain herbal preparations 7 days prior. If you're on fulvestrant, the last injection should be at least 42 days before starting the study drug.
What data supports the effectiveness of the drug Elacestrant for breast cancer?
Elacestrant, also known as Orserdu, has been approved by the FDA for treating certain types of advanced breast cancer, showing effectiveness in clinical trials for patients with estrogen receptor-positive, HER2-negative breast cancer. It has demonstrated anticancer activity in both laboratory and human studies, particularly for those who have not responded to other endocrine therapies.
12345Is Elacestrant safe for humans?
Elacestrant has been approved by the FDA for treating certain types of breast cancer, and its safety profile has been discussed in clinical trials. It may interact with other drugs and requires dose adjustments for people with liver issues, but ongoing studies are further evaluating its safety in different populations.
45678How is the drug Elacestrant unique for treating breast cancer?
Elacestrant is unique because it is an oral selective estrogen receptor degrader (SERD) that targets and degrades estrogen receptors, which are often involved in the growth of certain breast cancers. It is specifically approved for advanced or metastatic breast cancer in patients with certain mutations, offering a new option for those who have progressed after other endocrine therapies.
34589Eligibility Criteria
This trial is for men and women over 18 with ER+/HER2- advanced/metastatic breast cancer who haven't had CDK4/6 inhibitors before. Participants must have received up to two prior hormone therapies, have certain blood and organ function levels, possibly be on LHRH agonists if premenopausal or perimenopausal, and not be planning major surgery or other specific treatments.Inclusion Criteria
Your absolute neutrophil count is 1.5 or more.
Your hemoglobin level is at least 9.0 grams per deciliter.
Your blood albumin level is at least 3.0 g/dL (or 30 g/L).
+14 more
Exclusion Criteria
I haven't taken hormone therapy in the last 14 days.
I haven't taken any experimental cancer treatments recently.
My cancer has spread to my brain or spinal cord.
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
4 weeks
Treatment
Participants receive elacestrant starting at 400 mg daily until disease progression or treatment discontinuation
Up to 6 months
Survival Follow-Up
Participants are followed for survival approximately every 3 months
24 months
Adverse Events Follow-Up
Participants are monitored for adverse events for 28 days after the last treatment administration
4 weeks
Participant Groups
The study tests the effectiveness and safety of a drug called Elacestrant over six months in patients with a specific type of breast cancer that has spread. It aims to see how well this drug works when no previous CDK4/6 inhibitor therapy was given in the metastatic setting.
1Treatment groups
Experimental Treatment
Group I: ElacestrantExperimental Treatment1 Intervention
Subjects will take a starting dose of 400 mg of elacestrant dihydrochloride in tablet form once daily for up to 6 months.
Elacestrant is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Orserdu for:
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
🇪🇺 Approved in European Union as Orserdu for:
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Quality Cancer Care Alliance (QCCA) Northwest Medical SpecialtiesTacoma, WA
Toledo ClinicToledo, OH
Inventa Center for Cancer Research at Fort Wayne Medical Oncology and HematologyFort Wayne, IN
Highlands OncologySpringdale, AR
More Trial Locations
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Who Is Running the Clinical Trial?
Stemline Therapeutics, Inc.Lead Sponsor
Stemline Therapeutics, Inc.Lead Sponsor
References
Early Signs of Response to Elacestrant Seen in ER+ HER2- Breast Cancer. [2021]A phase I trial evaluated the selective estrogen receptor degrader elacestrant in breast cancer.
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. [2023]Patients with pretreated estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer have poor prognosis. Elacestrant is a novel, oral selective ER degrader that demonstrated activity in early studies.
Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. [2021]Advanced estrogen receptor-positive (ER+) breast cancer is currently treated with endocrine therapy. Elacestrant is a novel, nonsteroidal, selective estrogen receptor degrader with complex dose-related ER agonist/antagonist activity that is being developed as a treatment option for ER+ breast cancer.
Elacestrant: First Approval. [2023]Elacestrant (ORSERDU™) is an orally available selective estrogen receptor degrader (SERD) being developed by Stemline Therapeutics, a subsidiary of Menarini Group, for the treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. In January 2023, elacestrant received its first approval for the treatment of postmenopausal women or adult men with ER-positive, HER2-negative, estrogen receptor 1 (ESR1)-mutated (as determined by a US FDA-approved test) advanced or metastatic breast cancer with disease progression following ≥ 1 line of endocrine therapy in the USA. A regulatory assessment of elacestrant for the treatment of ER-positive, HER2-negative advanced or metastatic breast cancer is currently underway in the EU. Development of elacestrant for the treatment of vasomotor symptoms has been discontinued. This article summarizes the milestones in the development of elacestrant leading to this first approval for this indication.
Elacestrant: a new FDA-approved SERD for the treatment of breast cancer. [2023]Elacestrant (RAD-1901), a selective estrogen receptor degrader, was approved by USFDA on January 27, 2023, for the treatment of breast cancer. It has been developed by Menarini Group under the brand name Orserdu®. Elacestrant showed anticancer activity both in vitro and in vivo in ER+ HER2-positive breast cancer models. The present review delebrates the development stages of Elacestrant, with its medicinal chemistry, synthesis, mechanism of action, and pharmacokinetic studies. Clinical data and safety profile has also been discussed, including data from randomized trials.
Pharmacology and pharmacokinetics of elacestrant. [2023]Elacestrant, a novel oral selective estrogen receptor (ER) degrader (SERD), was approved by the Food and Drug Administration (FDA) on January 27, 2023, for use in patients with ER and/or progesterone receptor (PR)-positive and HER2-negative metastatic breast cancer whose tumors harbor an ESR1 missense mutation (ESR1-mut), after at least one line of endocrine therapy (ET). The FDA made its decision based on the randomized phase 3 EMERALD trial, which met its primary endpoint of improved median progression-free survival (mPFS) with elacestrant monotherapy versus standard-of-care endocrine monotherapy in the overall intention to treat population; however, this benefit was largely driven by the ESR1-mut cohort. Elacestrant is a dose-dependent mixed ER agonist/antagonist, which at high doses acts as a direct ER antagonist as well as selective downregulator of ER. It is 11% bioavailable, primarily metabolized by CYP3A4 in the liver and excreted in feces. This leads to drug-drug interactions with strong CYP3A4 inhibitors and inducers, such as itraconazole and rifampin, respectively. In accordance with its clearance route, dose reduction is recommended in patients with moderate hepatic dysfunction but not in renal dysfunction. Studies evaluating elacestrant in severe hepatic dysfunction as well as in patients from racial and ethnic minority groups are ongoing. Overall, elacestrant is the first orally bioavailable SERD approved by the FDA for use in patients with metastatic breast cancer. Current clinical trials are ongoing evaluating it in the adjuvant setting in patients with early stage ER-positive breast cancers.
First Approval of Elacestrant as a Selective Estrogen Receptor Degrader for the Treatment of Metastatic Breast Cancer. [2023]Elacestrant was approved by the US FDA on January 27, 2023, for treating postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression prior to using at least one line of endocrine therapy. In this short perspective, physicochemical properties, dosage and administration, mechanism of action, pharmacodynamics, pharmacokinetics, drug interaction, and treatment-related adverse reactions of elacestrant are summarized.
Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. [2023]This article aims to discuss elacestrant, an oral selective estrogen receptor downregulator approved by the Food and Drug Administration (FDA) in January 2023 for the treatment of hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Elacestrant (RAD1901), a Selective Estrogen Receptor Degrader (SERD), Has Antitumor Activity in Multiple ER+ Breast Cancer Patient-derived Xenograft Models. [2018]Purpose: Estrogen receptor-positive (ER+) breast cancers are typically treated with endocrine agents, and dependence on the ER pathway is often retained even after multiple rounds of antiestrogen therapy. Selective estrogen receptor degraders (SERD) are being developed as a strategy to more effectively target ER and exploit ER dependence in these cancers, which includes inhibiting both wild-type and mutant forms of ER. The purpose of this study was to evaluate the efficacy of a novel orally bioavailable SERD, elacestrant (RAD1901), in preclinical models of ER+ breast cancer.Experimental Design: Elacestrant was evaluated as a single agent and in combination with palbociclib or everolimus in multiple ER+ breast cancer models, including several patient-derived xenograft models.Results: Elacestrant induces the degradation of ER, inhibits ER-mediated signaling and growth of ER+ breast cancer cell lines in vitro and in vivo, and significantly inhibits tumor growth of multiple PDX models. Furthermore, we demonstrate that elacestrant in combination with palbociclib or everolimus can lead to greater efficacy in certain contexts. Finally, elacestrant exhibits significant antitumor activity both as a single agent and in combination with palbociclib in two patient-derived breast cancer xenograft models harboring ESR1 mutations.Conclusions: These data underscore the potential clinical utility of elacestrant as a single agent and as a combination therapy, for both early- and late-stage ER+ disease. Clin Cancer Res; 23(16); 4793-804. ©2017 AACR.