Study on Elacestrant for Patients with ER+ Breast Cancer and Circulating Tumor DNA
Sponsor: Yale University
ClinicalTrials ID:NCT06923527
This clinical trial is testing the use of the drug elacestrant for patients with ER+ breast cancer who show signs of circulating tumor DNA (ctDNA) in their blood. The study aims to see if elacestrant can help manage the cancer after initial treatment.
Patient Parameters
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Program Overview
The study is focused on patients with ER+ breast cancer who have completed their initial treatment but still show signs of cancer through circulating tumor DNA (ctDNA) in their blood. Participants will receive the drug elacestrant for one year and undergo regular testing to monitor their cancer status. The goal is to determine if elacestrant can help control the cancer after the main treatment has ended.
Description
This study involves patients with ER+ breast cancer who have completed their main treatment but still have circulating tumor DNA (ctDNA) in their blood, indicating potential cancer activity. Participants will take the drug elacestrant for one year and have regular CT scans and ctDNA tests every three months to monitor their condition. After the first year, patients will continue to have ctDNA tests every six months for another year. They may choose to continue taking elacestrant, return to standard hormone therapy, or follow regular cancer monitoring practices. The study aims to see if elacestrant can help manage cancer in patients who have completed their initial treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Previously diagnosed with ER+ HER2- breast cancer at stage IIB or III.
- Diagnosed with breast cancer at least five years ago and no more than 15 years ago.
- Completed initial hormone therapy and have been off it for at least six months before joining the study.
Exclusion Criteria
- Current metastatic breast cancer.
- Cannot take elacestrant due to medical reasons.
- Currently on hormone therapy.
- Previously treated with elacestrant or similar drugs.
- Have or had another invasive cancer, except for certain skin cancers or if cancer was treated successfully over five years ago.
- Cannot participate in another treatment trial while in this study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University | 06510 | New Haven | Connecticut |
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