ER+ Breast CancerPhase 2NCT06923527
Circulating Tumor DNA
A Phase 2 study testing Elacestrant in people with ER+ Breast Cancer, run by Yale University at 7 sites in United States.
Trial summary
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ER+ 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
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2025to Sep 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
- Adults aged 18 years and older.
- Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO/CAP guidelines. In the context of this trial, ER status will be considered positive if >10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. Patients with PR positive but ER-negative are not eligible.
- Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed adjuvant endocrine therapy.
- Participants must be off endocrine therapy for at least four weeks prior to screening.
- ctDNA positivity by NEXT Personal assay.
- No evidence of metastatic disease on staging scans.
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- If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed with enrollment. Patients with suspicious but inconclusive imaging results should undergo a diagnostic biopsy; if biopsy is negative patients are eligible for enrollment. Patients with positive imaging that is conclusive of metastatic disease, or biopsy proven metastatic disease, are not eligible.
- At the time of informed consent signature for treatment, participants may be either postmenopausal, premenopausal, or perimenopausal.
- Postmenopausal status is defined by: i. Age ≥60. ii. Age <60 and amenorrhea for 12 or more months (without an alternative cause) and FSH and estradiol level within postmenopausal range per local laboratory reference.
- Documentation of bilateral oophorectomy, at least one month before first dose of trial therapy.
- Premenopausal and perimenopausal participants must be willing to concurrently receive an LHRH agonist, and the LHRH agonist must be initiated at least three to four weeks before the start of elacestrant and are planning to continue LHRH agonist treatment during treatment with elacestrant. This is based on the current FDA approval of elacestrant in the metastatic setting which is limited to postmenopausal participants.
- Premenopausal or perimenopausal participants must be willing to use a highly effective method of contraception for the duration of trial treatment and for 120 days after the last dose of elacestrant OR if using barrier method of contraception must be willing to use a second form of contraception like occlusive cap with spermicidal foam / gel / film / cream / suppository.
- Highly effective methods of contraception are non-hormonal (cooper) intrauterine device (IUD), surgical sterilization (bilateral tubal occlusion/ligation, partner who has had a vasectomy), and sexual abstinence.
- 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) >1.0 x 109/L.
- Platelets >100 x 109/L.
- Hemoglobin > 8.0 g/dL.
- Potassium, sodium, calcium, and magnesium CTCAE v5.0 grade <1.
- Cockcroft-Gault based creatinine clearance >50 mL/min.
- ALT and AST <3 x ULN and total serum bilirubin <1.5 x ULN.
- Hypercholesterolemia and hypertriglyceridemia CTCAE v5.0 grade <1.
Who cannot join
- Known current metastatic disease.
- Known contraindication to receiving elacestrant as per FDA package insert.
- Current treatment with endocrine therapy.
- Prior treatment with elacestrant or other investigational SERDs.
- Current or past invasive cancer other than breast cancer, except:
- Adequately treated basal or squamous cell carcinoma of the skin.
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- Cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the treating physician.
- Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.
- Current use of strong and moderate CYP3A4 inducers/inhibitors or other prohibited concomitant medication unless an acceptable substitute is available, and the prohibited medication is discontinued at least five half-lives prior to initiation of elacestrant.
- Participants who are pregnant.
- Any concurrent severe and uncontrolled medical condition that would, in the sponsor-investigator's opinion, cause unacceptable safety risks or compromise compliance with the protocol including but not limited to:
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (uncontrolled Crohn's disease or ulcerative colitis, uncontrolled chronic nausea, vomiting, diarrhea, malabsorption, or small bowel resection).
- Females who are pregnant or breastfeeding.
- Moderate to severe liver impairment (Child-Pugh Class B and C).
- Hypercholesterolemia or hypertriglyceridemia > CTCAE v5.0 grade 1.
- Participants who are currently or are planning lactation during elacestrant treatment. Lactation during and at least one week following the last dose of elacestrant is not allowed
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21287
Sharon White, 410-614-1361, HopkinsBreastTrials@jhmi.edu
Jenna Canzoniero, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Ilana Schlam Camhi, MD MPH, 8773387425, ilana_schlam@dfci.harvard.edu
Ilana M Schlam Camhi, MD MPH
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Pamela Lewis, 713-563-4527, plewis@mdanderson.org
Carlos H Barcenas, MD MSc
- Recruiting
Yale University
New Haven, Connecticut, 06510
Carl Brown, 2037854095, carl.brown@yale.edu
Mariya Rozenblit, MD
- Not yet recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Joshua Plassmeyer, 412-648-6417, plassmeyerjm@upmc.edu
Julia Foldi, MD PhD
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
Fernando Gonterman, 718-405-8126, fgonterman@montefiore.org
Jesus Anampa, MD
- Recruiting
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Lana Kheir, 202-444-2223, lk814@georgetown.edu
Katia Khoury, MD
About this study
Official title: A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.
Read the detailed description
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing via the NEXT Personal MRD Detection test from Personalis. Patients who test positive for ctDNA during the screening phase will receive treatment with elacestrant for one year and continue ctDNA testing and imaging with CT scans every three months. During the follow-up period, patients in the study will continue to be ctDNA tested every six months and monitored for one year. If patients remain ctDNA positive at the completion of 12 months of study treatment, since they remain at increased risk of recurrence, they can choose to continue for an additional 12 months for a maximum of 24 months, they may also resume standard endocrine therapy or continue with standard of care surveillance during follow up.
- Conditions
- ER+ Breast Cancer
- Being tested
- Elacestrant
- Keywords
- stage IIB, stage III, ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Administration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity. The pills shall be administered with food (to reduce nausea and vomiting) at approximately the same time each day, and the prescription will be provided with the standard "Swallow tablets whole; do not chew, crush, or split" warning label.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Administration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer Patients
This study evaluates whether treatment with elacestrant improves the clearance of circulating tumor DNA (ctDNA) in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Patients included in the study have detectable ctDNA in their plasma but show no evidence of metastatic disease on imaging, and the results will be compared against historical control data.
Measured: Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment
Investigating Elacestrant's Effect on 18-Month Invasive Disease-Free Survival in ER+HER2- Breast Cancer Patients
To determine whether treatment with elacestrant improves the 18-month invasive disease-free survival rate in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The study focuses on patients with detectable circulating tumor DNA (ctDNA) in their plasma but who have no observable metastatic disease on imaging, comparing the outcomes to historical controls.
Measured: From the start of treatment through 18 months post-initiation of treatment
Secondary outcomes (8)
Incidence of ctDNA Positivity in Screened ER+HER2- Breast Cancer Patients
To estimate the incidence rate of circulating tumor DNA (ctDNA) positivity among patients screened for the study who have estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.
Measured: At baseline screening prior to treatment
Proportion of Patients with Metastatic Disease at First Positive ctDNA Result
This secondary outcome measure estimates the proportion of patients who present with clinically apparent metastatic disease (evident on imaging) at the time of their first positive ctDNA result.
Measured: From baseline screening through the first positive ctDNA detection, up to 12 months
Time to Relapse Between First Positive ctDNA and Clinical Recurrence of Metastatic Disease
To assess the duration between the first detection of positive ctDNA and the clinical recurrence of metastatic disease, as confirmed by imaging.
Measured: From the first positive ctDNA detection through clinical recurrence, up to 24 months
Association of ctDNA Clearance with Recurrence-Free Survival and Overall Survival
To evaluate whether clearance of ctDNA is associated with improved recurrence-free survival (RFS) and overall survival (OS) in ER+HER2- breast cancer patients
Measured: From baseline through 36 months post-treatment initiation
Safety, Tolerability, and Adherence to Elacestrant Treatment Protocol
To assess the safety and tolerability of the elacestrant treatment, as well as patients' adherence to the treatment protocol.
Measured: From baseline through the end of the treatment phase, up to 18 months
Patient-Reported Outcomes, Fear of Recurrence and Anxiety Levels During Elacestrant Treatment
To evaluate global patient-reported outcomes , fear of recurrence and anxiety levels during the elacestrant treatment phase.
Measured: From baseline through the end of the treatment phase, assessed every 3 months up to 18 months
Assessing AmDTx-MBCS' Impact on Decreasing Fear of Recurrence Scores
AmDTx-MBCS is a mobile health platform that combines psychoeducation, mindfulness/meditation, and cognitive based therapy practices. Investigators will evaluate the effect of AmDTx-MBCS on global patient-reported outcomes , fear of recurrence and anxiety levels during the elacestrant treatment phase.
Measured: Participation in the application will be offered at the first screening visit. Fear of recurrence will be assessed from baseline through the end of the treatment phase, assessed every 3 months up to 18 months.
Diet and Physical Activity Levels in Breast Cancer Patients
To assess self reported diet and physical activity levels among screened participants via Behavioral Risk Factor Surveillance System (BRFSS) and International Physical Activity Questionnaires (IPAQ) questionnaires.
Measured: At the first screening visit only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER+ Breast CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Stemline Therapeutics, Inc., Personalis Inc.
- Responsible party
- Principal investigator, Mariya Rozenblit, Yale University
- Investigators
- Mariya Rozenblit, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923527
- Sponsor's protocol ID
- 2000039112
- Status last verified
- May 2026
- First submitted
- 27 Mar 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)
- ClinicalTrials.gov ID
- NCT06923527
- Acronym / sponsor ID
- 2000039112
- Conditions
- ER+ Breast Cancer
- Keywords
- stage IIB, stage III, ctDNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Stemline Therapeutics, Inc., Personalis Inc.
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Apr 2025 (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.
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.
Detailed description
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing via the NEXT Personal MRD Detection test from Personalis. Patients who test positive for ctDNA during the screening phase will receive treatment with elacestrant for one year and continue ctDNA testing and imaging with CT scans every three months. During the follow-up period, patients in the study will continue to be ctDNA tested every six months and monitored for one year. If patients remain ctDNA positive at the completion of 12 months of study treatment, since they remain at increased risk of recurrence, they can choose to continue for an additional 12 months for a maximum of 24 months, they may also resume standard endocrine therapy or continue with standard of care surveillance during follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: ElacestrantAdministration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults aged 18 years and older.
- Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO/CAP guidelines. In the context of this trial, ER status will be considered positive if >10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. Patients with PR positive but ER-negative are not eligible.
- Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed adjuvant endocrine therapy.
- Participants must be off endocrine therapy for at least four weeks prior to screening.
- ctDNA positivity by NEXT Personal assay.
Key exclusion criteria (16 listed)
- Known current metastatic disease.
- Known contraindication to receiving elacestrant as per FDA package insert.
- Current treatment with endocrine therapy.
- Prior treatment with elacestrant or other investigational SERDs.
- Current or past invasive cancer other than breast cancer, except:
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 |
|---|---|---|
| ElacestrantAdministration of elacestrant will follow the FDA approved dose and schedule for patients with ER+ metastatic breast cancer. Elacestrant 345 mg will be administered orally once daily for 12 cycles or until disease progression or unacceptable toxicity. The pills shall be administered with food (to reduce nausea and vomiting) at approximately the same time each day, and the prescription will be provided with the standard "Swallow tablets whole; do not chew, crush, or split" warning label. | Drug | Single Arm |
Primary outcome
Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer Patients
Time frame: Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment
This study evaluates whether treatment with elacestrant improves the clearance of circulating tumor DNA (ctDNA) in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Patients included in the study have detectable ctDNA in their plasma but show no evidence of metastatic disease on imaging, and the results will be compared against historical control data.
Investigating Elacestrant's Effect on 18-Month Invasive Disease-Free Survival in ER+HER2- Breast Cancer Patients
Time frame: From the start of treatment through 18 months post-initiation of treatment
To determine whether treatment with elacestrant improves the 18-month invasive disease-free survival rate in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The study focuses on patients with detectable circulating tumor DNA (ctDNA) in their plasma but who have no observable metastatic disease on imaging, comparing the outcomes to historical controls.
8 secondary outcomes
Incidence of ctDNA Positivity in Screened ER+HER2- Breast Cancer Patients
Time frame: At baseline screening prior to treatment
Proportion of Patients with Metastatic Disease at First Positive ctDNA Result
Time frame: From baseline screening through the first positive ctDNA detection, up to 12 months
Time to Relapse Between First Positive ctDNA and Clinical Recurrence of Metastatic Disease
Time frame: From the first positive ctDNA detection through clinical recurrence, up to 24 months
Association of ctDNA Clearance with Recurrence-Free Survival and Overall Survival
Time frame: From baseline through 36 months post-treatment initiation
Safety, Tolerability, and Adherence to Elacestrant Treatment Protocol
Time frame: From baseline through the end of the treatment phase, up to 18 months
Patient-Reported Outcomes, Fear of Recurrence and Anxiety Levels During Elacestrant Treatment
Time frame: From baseline through the end of the treatment phase, assessed every 3 months up to 18 months
Assessing AmDTx-MBCS' Impact on Decreasing Fear of Recurrence Scores
Time frame: Participation in the application will be offered at the first screening visit. Fear of recurrence will be assessed from baseline through the end of the treatment phase, assessed every 3 months up to 18 months.
Diet and Physical Activity Levels in Breast Cancer Patients
Time frame: At the first screening visit only
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Mariya Rozenblit, MD principal investigator
Yale University
7 sites in 1 country: 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 ER+ Breast Cancer, run by Yale University at 7 sites in United States.
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 22 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Contact Laura Kane (773-369-6904, laura.kane@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer Patients (time frame: Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment). The study lists 2 primary outcomes in all. 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 21 Sep 2026.