Actively Recruiting
Circulating Tumor DNA
Led by Yale University · Updated on 2026-05-12
50
Participants Needed
7
Research Sites
100 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Circulating Tumor DNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with anatomic stage IIB or III ER+, HER2- breast cancer confirmed by pathology
- Diagnosis occurred at least five years ago and no more than 20 years ago
- Completed adjuvant endocrine therapy
- Off endocrine therapy for at least four weeks before screening
- Positive circulating tumor DNA (ctDNA) test by NEXT Personal assay
- No evidence of metastatic disease on staging scans
- Postmenopausal, premenopausal, or perimenopausal status at informed consent
- Premenopausal or perimenopausal participants agree to receive an LHRH agonist starting 3-4 weeks before elacestrant and continue during treatment
- Premenopausal or perimenopausal participants agree to use highly effective contraception during and for 120 days after treatment
- ECOG performance status of 0 or 1
- Adequate bone marrow and organ function as defined by laboratory values
You will not qualify if you...
- Known current metastatic disease
- Contraindication to elacestrant per FDA guidelines
- Current treatment with endocrine therapy
- Prior treatment with elacestrant or investigational SERDs
- Current or past invasive cancer other than breast cancer except treated basal or squamous cell carcinoma of the skin and cancer survivors with no recurrence for 5+ years and low risk
- Participation in another therapeutic clinical trial during screening or treatment phases
- Current use of strong or moderate CYP3A4 inducers/inhibitors or other prohibited medications unless discontinued appropriately
- Pregnancy
- Any severe uncontrolled medical condition posing safety risks
- Gastrointestinal conditions affecting oral medication absorption
- Females who are pregnant or breastfeeding
- Moderate to severe liver impairment (Child-Pugh Class B and C)
- Hypercholesterolemia or hypertriglyceridemia above grade 1
- Planning lactation or currently lactating during elacestrant treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
3
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
6
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
L
Laura Kane
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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