Circulating Tumor DNA

NCT06923527 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2000039112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

ER+ Breast Cancer

Keywords

stage IIB; stage III; ctDNA

Outcome Measures

Primary Outcomes (2)

• 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.

  Every 3 months during the treatment phase and at 3-month intervals for 12 months following the end of treatment

• 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.

  From the start of treatment through 18 months post-initiation of treatment

Secondary Outcomes (8)

• Incidence of ctDNA Positivity in Screened ER+HER2- Breast Cancer Patients

  At baseline screening prior to treatment

• Proportion of Patients with Metastatic Disease at First Positive ctDNA Result

  From baseline screening through the first positive ctDNA detection, up to 12 months

• Time to Relapse Between First Positive ctDNA and Clinical Recurrence of Metastatic Disease

  From the first positive ctDNA detection through clinical recurrence, up to 24 months

• Association of ctDNA Clearance with Recurrence-Free Survival and Overall Survival

  From baseline through 36 months post-treatment initiation

• Safety, Tolerability, and Adherence to Elacestrant Treatment Protocol

  From baseline through the end of the treatment phase, up to 18 months

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Elacestrant

Interventions

Elacestrant DRUG

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men 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.

You may not qualify if:

• 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:
• 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.
• Current use of strong and moderate CYP3A4 inducers/inhibitors or other prohibited concomitant medication unless an acceptable substitute is available, and the prohibited medication is discontinued at least five half-lives prior to initiation of elacestrant (refer section 9.9 of the protocol for prohibited concomitant medications).
• Participants who are pregnant.
• ctDNA positivity by NEXT Personal assay.
• No evidence of metastatic disease on staging scans.
• a. If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed with enrollment. Patients with suspicious but inconclusive imaging results should undergo a diagnostic biopsy; if biopsy is negative patients are eligible for enrollment. Patients with positive imaging that is conclusive of metastatic disease, or biopsy proven metastatic disease, are not eligible.
• At the time of informed consent signature for treatment, participants may be either postmenopausal, premenopausal, or perimenopausal.
• a. Postmenopausal status is defined by: i. Age ≥60. ii. Age \<60 and amenorrhea for 12 or more months (without an alternative cause) and FSH and estradiol level within postmenopausal range per local laboratory reference.

Sponsors & Collaborators

• Yale University: lead
• Johns Hopkins University: collaborator
• Stemline Therapeutics, Inc.: collaborator

Study Sites (7)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Interventions

elacestrant

Study Officials

• Mariya Rozenblit, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Kane

CONTACT

773-369-6904; laura.kane@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 11, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-02

Locations

US (7)