Metastatic Breast CancerPhase 2ELCINNCT05596409
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
A Phase 2 study testing Elacestrant in people with Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 22 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Elacestrant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 19 May 2023to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed the informed consent before all study specific activities are conducted.
- Women or men aged ≥18 years (or the minimum age of consent as per local law), at the time of informed consent signature. Female patients may be either postmenopausal or premenopausal/perimenopausal.
- Premenopausal or perimenopausal women and men must be concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planning to continue LHRH during the study.
- For perimenopausal women to be considered of non-childbearing potential, follicle-stimulating hormone (FSH) levels must be >40 milli-international units per milliliter (mIU/mL).
- 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. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.
- Radiological disease progression during or after the most recent therapy in the advanced/metastatic setting
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- Patient has received at least one (and up to two) prior hormonal therapy in the advanced/metastatic setting.
- Patients with disease relapse while on adjuvant endocrine therapy after the 2 first years, or with disease relapse within 12 months of completing adjuvant endocrine therapy are allowed (i.e., patients with secondary-resistant breast cancer according to the 5th European School of Oncology (ESO)-European Society for Medical Oncology (ESMO) international consensus guidelines for advanced breast cancer, Cardoso et al 2020). This therapy will be considered as first line treatment for eligibility purposes.
- At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or a mainly lytic bone lesion for bone only disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient has adequate bone marrow and organ function, as defined by the following laboratory values:
- Absolute neutrophil count (ANC) ≥1.5 × 10^9/liter(L)
- Platelets ≥100 × 10^9/L
- Hemoglobin ≥9.0 grams(g)/deciliter(dL)
- Potassium, sodium, calcium (corrected for serum albumin) and magnesium, Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≤1. Note: Corrected calcium for serum albumin must be calculated manually by the site using the Payne formula: Corrected calcium (milligrams [mg]/dL) = measured total calcium (mg/dL) + 0.8 (Normal albumin [g/dL] - serum albumin [g/dL]), where normal albumin is usually defaulted to 4.0 g/dL.
- Cockcroft-Gault based creatinine clearance ≥50 milliliters per minute (mL/min). Note: Creatinine clearance (male) = ([140-age in years] × weight in kilograms [kg])/ ([serum creatinine in mg/dL] × 72) Creatinine clearance (female) = (0.85 × [140-age in years] × weight in kg)/ ([serum creatinine in mg/dL] × 72)
- Serum albumin ≥3.0 g/dL (≥30 g/L)
- 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
- If the patient has liver metastases, ALT, and AST ≤5.0 × ULN
- Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN. Note: Laboratory assessments may be repeated during the Screening Phase after supplementation or transfusions (a single red blood cells transfusion is allowed once during the screening period).
Who cannot join
- Active or newly diagnosed central nervous system (CNS) metastases, including meningeal carcinomatosis.
- Patients with advanced, symptomatic visceral crisis who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial) and liver involvement of >50%.
- Prior chemotherapy, elacestrant, or CDK4/6i in the advanced/metastatic setting.
- Patients with only disease relapse while on the first 2 years of adjuvant endocrine therapy i.e., patients with primary endocrine resistance, are not eligible.
- Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative treatment.
- Uncontrolled significant active infections.
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- Patients with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection must have undetectable viral load during screening.
- Patients known to be human immunodeficiency virus (HIV)+ are allowed as long as they have undetectable viral load at baseline.
- Major surgery within 28 days before starting trial therapy.
- Systemic radiotherapy within 14 days before starting trial therapy, or central nervous system (CNS) radiotherapy within 28 days before starting trial therapy. Inability to take oral medication, refractory or chronic nausea, gastrointestinal condition (including significant gastric or bowel resection), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that may impact the absorption of study drug.
- Known intolerance to elacestrant or any of its excipients.
- Females of childbearing potential who do not agree to use a highly effective method of contraception and to abstain from donating/freezing ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal methods of contraception should be used.
- Men who do not agree to abstain from donating/freezing sperm, or to use a highly effective method of contraception within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. For subjects (who have not undergone vasectomy) with female partners of childbearing potential, the subject and his partner must use highly effective methods of contraception.
- Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.
- Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:
- Investigational anti-cancer therapy within 14 days (28 days in case of anticancer antibody-based treatments) or 5 half-lives, whichever is shorter.
- Fulvestrant treatment (last injection) <42 days before first dose of study drug.
- Any other endocrine therapy <14 days before first dose of study drug.
- Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter.
- Herbal preparations/medications within 7 days. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.
- Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the patient's participation in a clinical study
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
Brazil8 sites
Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Centro De Pesquisa Clinica DO Hospital Sirio-Libanes - UNIDADE Brasilia
Brasília, 70200-730
Centro de Pesquisas Clinicas em Oncologia (Center for Clinical Research in Oncology (CPCO)) - Hospital Evangélico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, 29308-014
Centro de Pesquisas Oncologicas
Florianópolis, Santa Catarina, 88034-000
Hospital São Lucas PUCRS - Centro de Pesquisa em Oncologia (CPO)
Porto Alegre, Rio Granda Do Sul, 70200-730
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Granda Do Sul, 90035
Centro de Estudos e Pesquisas de Hematologia e Oncologia- CEPHO
Santo André, São Paulo, 09060-650
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda
São Paulo, 01317-001
United States4 sites
Northwestern University, Northwestern Feinberg School of Medicine Prentice Women's Hospital
Chicago, Illinois, 60611
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128
UT Health San Antonio Mays Cancer Center
San Antonio, Texas, 78229
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Mexico4 sites
Torre Medica Hospital Dalinde
Mexico City, 06760
Fucam, Ac.
Mexico City, 4980
I CAN Oncology Center, Centro Medico AVE
Monterrey, Nuevo León, 64710
Unidad Médica Onco-Hematológica
Puebla City, 4515
Georgia3 sites
Innova Medical Center
Tbilisi, 179
LTD Simon Khechinashvili University Clinic
Tbilisi, 179
Institute of Clinical Oncology
Tbilisi
Bulgaria2 sites
Complex Oncology Center
Plovdiv, 4000
COMPLEX ONCOLOGICAL CENTER - Shumen
Shumen, 9700
Romania1 site
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, Cluj, 400150
About this study
Official title: ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)
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.
Read the detailed description
This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6i in the metastatic setting.
The study duration for each patient is estimated to be:
- Screening Phase: Up to 28 days prior to Cycle 1, Day 1 (C1D1);
- Treatment Phase: From C1D1 until the date of radiologically documented progression, or treatment discontinuation due to other reasons.
- Survival Follow-Up Phase: All patients will be followed for survival approximately every 3 months up to 24 months after enrollment of the last patient.
Patients will be followed for adverse events (AEs) for 28 days after the last treatment administration.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Elacestrant
- Keywords
- metastatic breast cancer, breast cancer, elacestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Starting dose 400 mg elacestrant dihydrochloride administered orally once daily for an estimated 6 months of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Elacestrant | Experimental | Subjects will take a starting dose of 400 mg of elacestrant dihydrochloride in tablet form once daily for up to 6 months. Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first.
Measured: 36 months
Secondary outcomes (4)
Overall response rate
Proportion of patients who achieve a best overall response of partial response or complete response
Measured: 24 months
Duration of response
Time from the date of first documented complete response or partial response until the first radiological documentation of disease progression or death, whichever comes first
Measured: 36 months
Clinical benefit rate
Proportion of patients who achieve a best overall response of confirmed complete response or partial response or durable stable disease (duration at least 24 weeks from date of first dose)
Measured: 36 months
Overall survival
Time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start19 May 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596409
- Sponsor's protocol ID
- STML-ELA-0322
- Acronym
- ELCIN
- Status last verified
- May 2026
- First submitted
- 24 Oct 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)
- ClinicalTrials.gov ID
- NCT05596409
- Acronym / sponsor ID
- ELCIN / STML-ELA-0322
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, breast cancer, elacestrant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6i in the metastatic setting.
The study duration for each patient is estimated to be:
- Screening Phase: Up to 28 days prior to Cycle 1, Day 1 (C1D1);
- Treatment Phase: From C1D1 until the date of radiologically documented progression, or treatment discontinuation due to other reasons.
- Survival Follow-Up Phase: All patients will be followed for survival approximately every 3 months up to 24 months after enrollment of the last patient.
Patients will be followed for adverse events (AEs) for 28 days after the last treatment administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elacestrant | Experimental | Drug: ElacestrantSubjects will take a starting dose of 400 mg of elacestrant dihydrochloride in tablet form once daily for up to 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient has signed the informed consent before all study specific activities are conducted.
- Women or men aged ≥18 years (or the minimum age of consent as per local law), at the time of informed consent signature. Female patients may be either postmenopausal or premenopausal/perimenopausal.
- 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. Note: In the context of this trial, ER status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.
- Radiological disease progression during or after the most recent therapy in the advanced/metastatic setting
- Patient has received at least one (and up to two) prior hormonal therapy in the advanced/metastatic setting.
Key exclusion criteria (21 listed)
- Active or newly diagnosed central nervous system (CNS) metastases, including meningeal carcinomatosis.
- Patients with advanced, symptomatic visceral crisis who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial) and liver involvement of >50%.
- Prior chemotherapy, elacestrant, or CDK4/6i in the advanced/metastatic setting.
- Patients with only disease relapse while on the first 2 years of adjuvant endocrine therapy i.e., patients with primary endocrine resistance, are not eligible.
- Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElacestrantStarting dose 400 mg elacestrant dihydrochloride administered orally once daily for an estimated 6 months of treatment. | Drug | Elacestrant |
Primary outcome
Progression-free survival (PFS)
Time frame: 36 months
PFS is defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first.
4 secondary outcomes
Overall response rate
Time frame: 24 months
Duration of response
Time frame: 36 months
Clinical benefit rate
Time frame: 36 months
Overall survival
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elacestrant in people with Metastatic Breast Cancer, run by Stemline Therapeutics, Inc. at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Brazil, United States, Mexico, Georgia, Bulgaria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.