Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05826964
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-04-12
Brief Title:
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic Stage IV Breast Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CDK46i 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None