NCT06923527

Circulating Tumor DNA

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients with ER+ breast cancer anatomic stage IIB or III at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctDNA testing. Patients who test positive for ctDNA during the screening phase will receive treatment with elacestrant for one year and continue ctDNA testing and imaging with CT scans every three months. During the follow-up period, patients in the study will continue to be ctDNA tested every six months and monitored for one year. If patients remain ctDNA positive at the completion of 12 months of study treatment, since they remain at increased risk of recurrence, they can choose to continue for an additional 12 months for a maximum of 24 months, they may also resume standard endocrine therapy or continue with standard of care surveillance during follow up.

Conditions

• ER+ Breast Cancer

Interventions

Type	Name	Description
DRUG	Elacestrant	Administration 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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-04-11
• Last updated: 2026-03-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study