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Selective Estrogen Receptor Degrader (SERD)
Elacestrant for Breast Cancer (ELCIN Trial)
Phase 2
Recruiting
Research Sponsored by Stemline Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documentation of histopathologically or cytologically confirmed ER+, HER2-breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020, Wolff et al, 2018). Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.
In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the patient has liver metastases, ALT and AST ≤5 × ULN
Must not have
Investigational anti-cancer therapy within 14 days (28 days in case of anticancer antibody-based treatments) or 5 half-lives, whichever is shorter.
Uncontrolled significant active infections.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how well a drug works and how safe it is for advanced breast cancer patients who haven't had prior treatment.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the trial information doesn't list specific side effects for Elacestrant, common ones for similar drugs include nausea, fatigue, hot flashes, joint pain, headache, increased risk of infections due to low white blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER+ and HER2- as confirmed by tests.
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My liver function tests are within the required range.
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I am 18 or older and understand the consent I am giving.
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My kidneys work well enough to clear waste from my blood.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken any experimental cancer treatments recently.
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I do not have any severe ongoing infections.
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My cancer has spread to my brain or spinal cord.
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I cannot take pills due to stomach or bowel issues that affect drug absorption.
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I haven't taken strong or moderate drugs affecting liver enzymes recently.
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I have received chemotherapy or specific cancer drugs for advanced cancer.
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My hepatitis B or C viral load is undetectable.
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My cancer has spread significantly and is causing severe symptoms.
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I received my last Fulvestrant injection less than 42 days ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Clinical benefit rate
Duration of response
Overall response rate
+1 moreSide effects data
From 2024 Phase 3 trial • 478 Patients • NCT0377893135%
Nausea
19%
Fatigue
19%
Vomiting
15%
Decreased appetite
14%
Diarrhoea
14%
Arthralgia
14%
Back pain
13%
Aspartate aminotransferase increased
12%
Constipation
12%
Headache
11%
Hot flush
10%
Dyspepsia
9%
Asthenia
9%
Anaemia
9%
Alanine aminotransferase increased
8%
Insomnia
8%
Dyspnoea
8%
Pain in extremity
7%
Urinary tract infection
7%
Blood cholesterol increased
6%
Blood alkaline phosphatase increased
6%
Abdominal pain
6%
Musculoskeletal chest pain
6%
Cough
6%
Bone pain
5%
Myalgia
5%
Musculoskeletal pain
5%
Lymphocyte count decreased
4%
Blood pressure Increased
3%
Blood glucose increased
1%
Spinal cord compression
1%
Small intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Elacestrant
Standard of Care (SoC)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elacestrant
2019
Completed Phase 3
~560
Find a Location
Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
6,447 Total Patients Enrolled
3 Trials studying Breast Cancer
5,098 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your absolute neutrophil count is 1.5 or more.I haven't taken hormone therapy in the last 14 days.I haven't taken any experimental cancer treatments recently.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).My cancer has spread to my brain or spinal cord.I agree to use effective birth control during and for 28 days after the study.I have a measurable cancer lesion or a bone lesion, and if I have brain metastases, they are stable.My blood tests show my organs and bone marrow are working well.I have had 1 or 2 hormone treatments for my advanced cancer.I do not have any severe ongoing infections.I have not taken any herbal supplements like St. John's wort or ginseng in the last week.I cannot take pills due to stomach or bowel issues that affect drug absorption.My breast cancer is ER+ and HER2- as confirmed by tests.My liver function tests are within the required range.Your total bilirubin level in the blood should be less than 1.5 times the upper limit of normal, except if you have Gilbert's syndrome, in which case it should be less than 3 times the upper limit of normal.I agree to use effective birth control or not donate sperm during and for 120 days after treatment.I haven't taken strong or moderate drugs affecting liver enzymes recently.I have not had major surgery or radiotherapy in the last 28 days.I have received chemotherapy or specific cancer drugs for advanced cancer.I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.I am 18 or older and understand the consent I am giving.I am premenopausal or perimenopausal and will start LHRH treatment 4 weeks before the trial.Perimenopausal women are not able to have children if their FSH levels are above 40 mIU/mL.Your platelet count is at least 100 billion per liter.My hepatitis B or C viral load is undetectable.My cancer has spread significantly and is causing severe symptoms.People with HIV can join if their virus level is not detectable.Your levels of potassium, sodium, calcium, and magnesium in your blood are within normal range.My kidneys work well enough to clear waste from my blood.I received my last Fulvestrant injection less than 42 days ago.You are currently abusing alcohol or drugs, as determined by the research team.I am fully active or can carry out light work.You are allergic to elacestrant or any of its ingredients.I have not used effective birth control in the last 28 days.I am currently taking or have taken specific medications before starting the trial therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Elacestrant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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