RECRUITING

ctDNA Guided Adjuvant Treatment With Elacestrant: TBCRC-068

Conditions

ER+ Breast Cancer stage IIB stage III ctDNA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06923527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Women or men aged 18 years and older. 2. 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 who are PR positive but ER-negative are not eligible. 3. Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 15 years ago and must have completed adjuvant endocrine therapy. 4. Participants must be off endocrine therapy for at least six months prior to screening.	1. Known current metastatic disease. 2. Known contraindication to receiving elacestrant as per FDA package insert. 3. Current treatment with endocrine therapy. 4. Prior treatment with elacestrant or other investigational SERDs. 5. Current or past invasive cancer other than breast cancer, except: 1. Adequately treated basal or squamous cell carcinoma of the skin. 2. 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. 6. Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.

Inclusion Criteria

Exclusion Criteria

1. Women or men aged 18 years and older.
2. 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 who are PR positive but ER-negative are not eligible.
3. Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 15 years ago and must have completed adjuvant endocrine therapy.
4. Participants must be off endocrine therapy for at least six months prior to screening.

1. Known current metastatic disease.
2. Known contraindication to receiving elacestrant as per FDA package insert.
3. Current treatment with endocrine therapy.
4. Prior treatment with elacestrant or other investigational SERDs.
5. Current or past invasive cancer other than breast cancer, except:
1. Adequately treated basal or squamous cell carcinoma of the skin.
2. 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.
6. Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.

Contacts and Locations

Study Contact

Stephanie Ladd

CONTACT

954-895-0576

stephanie.ladd@yale.edu

Principal Investigator

Mariya Rozenblit, MD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06510

United States

Collaborators and Investigators

Sponsor: Yale University

Mariya Rozenblit, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

stage IIB
stage III
ctDNA

Additional Relevant MeSH Terms

ER+ Breast Cancer