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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
ELCIN Trial 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.Check my eligibility
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.See study design
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.
ELCIN Trial 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.
ELCIN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival rate
Secondary outcome measures
Clinical benefit rate
Duration of response
Overall response rate
+2 moreELCIN 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
2015
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Stemline Therapeutics, Inc.Lead Sponsor
19 Previous Clinical Trials
2,045 Total Patients Enrolled
2 Trials studying Breast Cancer
878 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Elacestrant been granted regulatory clearance by the FDA?
"Our team has assigned Elacestrant a safety score of 2, as this Phase 2 trial provides evidence that the drug is safe but lacks any data confirming its efficacy."
Answered by AI
What is the ultimate goal of this clinical experiment?
"This clinical trial will assesses its primary outcome, Progression Free Survival Rate, over a 6 month period. Secondary endpoints of the study comprise Clinical Benefit Rate (the portion of patients achieving either confirmed complete response or partial response), and Progression-Free Survival, which is measured from date of first dose to onset of disease progression or death."
Answered by AI
Is the enrollment stage of this clinical trial still open?
"As recorded on clinicaltrials.gov, this trial is still taking in participants and was first posted on August 1st 2023 with its last update occurring June 27th 2023."
Answered by AI
How many individuals are currently taking part in this experiment?
"Affirmative. According to the information displayed on clinicaltrials.gov, this trial is actively seeking out participants since its initial posting on August 1st 2023 and latest update on June 27th 2023. In total they need 80 patients from a single site for completion of their research."
Answered by AI
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