Phase 2 Elacestrant for ER+ Breast Cancer with Circulating Tumor DNA
This study is looking at how well elacestrant works in people with ER+ (estrogen receptor positive) breast cancer that is HER2- (HER2 negative). You might be able to join if you have stage IIB or III ER+HER2- breast cancer, are at least 18 years old, and have circulating tumor DNA (ctDNA) in your blood. ctDNA is tiny pieces of cancer DNA that can be found in your bloodstream. The study will give elacestrant orally once a day for about a year. Researchers will check if elacestrant helps clear the ctDNA and how it affects your chance of staying cancer-free for 18 months. The study is currently unclear about its recruitment status.
- Study design
- This is a single-arm, Phase 2 study with 50 planned participants. This means everyone in the study will receive the same treatment.
- What's involved
- You would be screened for ctDNA. If positive, you would take elacestrant daily for 12 cycles (about a year), with ctDNA testing and CT scans every three months during treatment, and ctDNA testing every six months during follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for 12 months after treatment ends, with the option to continue for an additional 12 months if ctDNA positive.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Circulating Tumor DNA
At a glance
Conditions
Where it's being run
7 sites across 7 statesStudy leadership
- Mariya Rozenblit, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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What this trial measures
- Assessing Elacestrant's Impact on ctDNA Clearance in ER+HER2- Breast Cancer PatientsEvery 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 PatientsFrom 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.