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NCT05826964 · ClinicalTrials.gov registry record · Phase 2
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 study of Breast Cancer and Metastatic Breast Cancer, sponsored by University of Miami.
- Active
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05826964 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is active but no longer recruiting, run by University of Miami. The registered enrollment target is 24 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05826964, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is active but no longer recruiting, sponsored by University of Miami.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG AI+CDK4/6i
- DRUG SERD+CDK4/6i
- DRUG mTOR inhibitor + AI
- DRUG mTOR inhibitor + SERD
- DRUG mTOR inhibitor + Selective estrogen receptor modulator
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-06-12 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05826964
The ClinicalTrials.gov registry entry for NCT05826964 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which AI+CDK4/6i is the first listed.
NCT05826964 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05826964 about?
NCT05826964 is a clinical study titled "Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer". 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 ...
What is the current status of trial NCT05826964?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-06-12. Estimated completion is 2029-07-31.
What conditions does trial NCT05826964 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, HER2-Negative Breast Cancer, ER Positive Breast Cancer.
What interventions are being tested in trial NCT05826964?
The interventions under investigation include: AI+CDK4/6i (DRUG), SERD+CDK4/6i (DRUG), mTOR inhibitor + AI (DRUG), mTOR inhibitor + SERD (DRUG), mTOR inhibitor + Selective estrogen receptor modulator (DRUG).
Who is sponsoring clinical trial NCT05826964?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05826964 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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