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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Elacestrant
DrugAdministration 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Single ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment2
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.
Time frame
From the start of treatment through 18 months post-initiation of treatmentSecondary outcomes
1
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.
Time frame
At baseline screening prior to treatment2
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.
Time frame
From baseline screening through the first positive ctDNA detection, up to 12 months3
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.
Time frame
From the first positive ctDNA detection through clinical recurrence, up to 24 months4
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
Time frame
From baseline through 36 months post-treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Johns Hopkins University
Collaborator
Stemline Therapeutics, Inc.
Collaborator
Personalis Inc.
Collaborator
Source ClinicalTrials.gov