Circulating Tumor DNA (NCT06923527) | Clinical Trial Compass
RecruitingPhase 2
Circulating Tumor DNA
United States50 participantsStarted 2025-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer Patients
Timeframe: Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment
2
Investigating Elacestrant's Effect on 18-Month Invasive Disease-Free Survival in ER+HER2- Breast Cancer Patients
Timeframe: From the start of treatment through 18 months post-initiation of treatment
. Adequately treated basal or squamous cell carcinoma of the skin.
. 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.