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Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer | Clinical Trials | Clareo Health

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Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study

NCT05826964•University of Miami

View on ClinicalTrials.gov

Summary

The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC). Currently frontline therapy for pts with HR+ ABC is antihormonal therapy with an aromatase inhibitor or selective estrogen receptor degrader plus a CDK4/6i. The proposed trial is a randomized study to further evaluate the potential benefit of switching a frontline regimen at the time that a molecular signal, ctDNA, suggests progression prior to detection of clinical progression using standard methods. The purpose of this study is to determine whether switching treatment earlier in the disease process, based on molecular progression, will increase the amount of time that a patient's metastatic breast cancer is controlled compared to patients with metastatic breast cancer who receive treatment later based on diagnostic imaging results or other methods currently used in medical practice.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men or women age ≥ 18 years.
•2. Patients with a diagnosis of ER+, human epidermal growth factor receptor 2 negative (HER2-) metastatic (Stage IV) breast cancer. Positivity status is defined as \>10% staining for ER and immunohistochemistry (IHC) 0+ or IHC 1 or 2+ staining for HER-2, and fluorescence in situ hybridization (FISH) negative with standard pathology staining methods.
•3. Patients with de novo metastatic disease at the Screening Visit must undergo a SOC diagnostic biopsy.
•4. Archived tumor tissue available.
•5. Women and men with proven locally advanced, locoregionally recurrent or metastatic disease adenocarcinoma of the breast not amenable to curative therapy. Note: patients relapsing while on adjuvant tamoxifen or AI are eligible for this study.
•6. No prior systemic anticancer therapy for metastatic or advanced disease (chemotherapy targeted therapy or endocrine therapy (ET)).
•Note 1: prior endocrine therapy in the metastatic setting is not allowed unless initiated \<30 days from study initiation or Cycle 1, Day 1 (C1D1).
•Note 2: prior initiation of luteinizing hormone-releasing hormone (LHRH) agonist or bone-directed agents, however, is allowed.
•7. No visceral crisis. Visceral crisis is defined as advanced, symptomatic, visceral spread that is at risk of life-threatening complication in the short term and that requires chemotherapy.
•8. Adequate organ and marrow function as defined below:
+30 more criteria

Exclusion Criteria

•1. Patients who are currently receiving or have received treatment for a secondary cancer other than resected non-melanoma skin cancer lesions or in situ cancer within the past 24 months.
•2. Prior exposure to CDK4/6i ≤12 months prior to enrollment.
•3. Use of investigational drugs ≤28 days prior to study enrollment and during the study.
•4. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the Investigator.
•5. Locally advanced breast cancer or locoregional relapse amenable for any treatment with curative intent.
•6. HER2+ or equivocal tumor status either on the primary or on the recurrent tumor defined as IHC 3+, FISH/chromogenic in situ hybridization (CISH) amplified or FISH/CISH equivocal according to the American Society of Clinical Oncologists (ASCO) 2015 criteria.
•7. Prior endocrine therapy in the metastatic setting is not allowed unless initiated \< 30 days from study initiation or Cycle 1, Day 1 (C1D1).
•8. Prior treatment with any CDK 4/6 inhibitor in the metastatic setting is not allowed.
•9. Any major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of treatment; however, surgical diagnostic procedure is allowed (even if under general anesthesia).
•10. Known active, bleeding diathesis.
+3 more criteria

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

June 12, 2023

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2029

Last Updated

January 13, 2026

Enrollment

ESTIMATED participants

Conditions

Breast CancerER-positive Breast CancerHER2-negative Breast CancerMetastatic Breast Cancer

Interventions

AI+CDK4/6i

DRUG

SERD+CDK4/6i

DRUG

mTOR inhibitor + AI

DRUG

mTOR inhibitor + SERD

DRUG

mTOR inhibitor + Selective estrogen receptor modulator

DRUG

PI3K inhibitor + SERD

DRUG

PI3K inhibitor + AI

DRUG

Chemotherapy

DRUG

Oral SERD

DRUG

PARPi

DRUG

AKT inhibitor

DRUG

Step 3 Arm 2

OTHER

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

NCT05245812

Breast CancerHigh Risk of Breast Cancer

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Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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