Circulating Tumor DNA
ConditionER+ Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Elacestrant
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
7Connecticut
Yale University06510, New Haven United States
District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center20007, Washington D.C. United States
Maryland
Sidney Kimmel Comprehensive Cancer Center at John Hopkins21287, Baltimore United States
Massachusetts
Dana-Farber Cancer Institute02215, Boston United States
Sponsors and collaborators
Yale University
Lead sponsor
Johns Hopkins University
Collaborator
Stemline Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov