Elacestrant for Breast Cancer (ELCIN Trial)
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Stemline Therapeutics, Inc.
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.
Is the drug Elacestrant a promising treatment for breast cancer?Yes, Elacestrant is a promising drug for breast cancer. It has been approved by the FDA for treating certain types of advanced breast cancer. It works by targeting and breaking down estrogen receptors, which are often involved in the growth of breast cancer cells. Studies have shown that Elacestrant can effectively reduce tumor growth, both on its own and when used with other cancer treatments.12579
What safety data is available for Elacestrant in breast cancer treatment?Elacestrant, also known as Orserdu, was approved by the FDA in January 2023 for treating ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. The approval was based on the phase 3 EMERALD trial, which showed improved median progression-free survival with elacestrant monotherapy compared to standard endocrine therapy. The safety profile includes treatment-related adverse reactions, and drug interactions with CYP3A4 inhibitors and inducers. Dose reduction is recommended for patients with moderate hepatic dysfunction. Ongoing studies are evaluating its safety in severe hepatic dysfunction and diverse racial and ethnic groups.56789
Do I need to stop my current medications to join the trial?Yes, you may need to stop certain medications. You cannot take investigational anti-cancer therapy within 14 days, fulvestrant within 42 days, or any other endocrine therapy within 14 days before starting the trial. Also, avoid strong or moderate inducers or inhibitors of CYP3A4 within 14 days and herbal preparations within 7 days before the trial.
What data supports the idea that Elacestrant for Breast Cancer is an effective drug?The available research shows that Elacestrant, also known as Orserdu, has been approved by the USFDA for treating certain types of breast cancer. It has shown anticancer activity in both lab and animal studies for ER-positive, HER2-negative breast cancer. A significant study, the EMERALD trial, compared Elacestrant to standard endocrine therapy and demonstrated its effectiveness in patients with advanced breast cancer who had already received other treatments. This suggests that Elacestrant can be a promising option for patients with this type of breast cancer.23457
Eligibility 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
My breast cancer is ER+ and HER2- as confirmed by tests.
My liver function tests are within the required range.
I am 18 or older and understand the consent I am giving.
My kidneys work well enough to clear waste from my blood.
I am fully active or can carry out light work.
Exclusion Criteria
I haven't taken any experimental cancer treatments recently.
I do not have any severe ongoing infections.
My cancer has spread to my brain or spinal cord.
I cannot take pills due to stomach or bowel issues that affect drug absorption.
I haven't taken strong or moderate drugs affecting liver enzymes recently.
I have received chemotherapy or specific cancer drugs for advanced cancer.
My hepatitis B or C viral load is undetectable.
My cancer has spread significantly and is causing severe symptoms.
I received my last Fulvestrant injection less than 42 days ago.
Treatment Details
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
References
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.
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.
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.
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.
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: 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.
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.