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NCT03195192 · ClinicalTrials.gov registry record · NA
Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer
A NA study of Metastatic Breast Cancer, sponsored by Side-Out Foundation.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
- 8
- Study locations
NCT03195192 is a NA study of Metastatic Breast Cancer that has completed, run by Side-Out Foundation. The registered enrollment target is 28 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT03195192, a NA study of Metastatic Breast Cancer, has completed, sponsored by Side-Out Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is an open-label, multicenter study in patients with metastatic breast cancer who are candidates for standard first line treatment with palbociclib or ribociclib plus endocrine therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal regimen for metastatic disease. However, patients may still be considered eligible if they have already started treatment with endocrine therapy (an aromatase inhibitor or fulvestrant) plus palbociclib or ribociclib for no longer than 4 weeks prior to study enrollment, as long as they meet all other eligibility criteria. Eligible patients must have had a diagnostic biopsy of the metastatic lesion no more than 4 months prior to study enrollment and with sufficient tissue to complete the proposed biomarker analysis. Patients who develop disease progression within the first 12 months of starting palbociclib or ribociclib plus endocrine therapy will be eligible for an optional additional tissue biopsy at time of disease progression to repeat the analysis at time of disease progression and obtain real-time (10-14-day turn-around) multi-omic data produced under College of American Pathologist (CAP)/Clinical Laboratory Improvement Amendments (CLIA) development and/or compliant practices.
Conditions Studied
Interventions
- OTHER biomarker study
Study Locations (8)
Pennsylvania
- Abramson Cancer Center Perelman Center for Advanced Medicine - Philadelphia
- Thomas Jefferson University Sidney Kimmel Cancer Center - Philadelphia
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Cedars-Sinai Medical Center - Los Angeles
Florida
- UHealth/Sylvester Comprehensive Cancer Center - Miami
Rhode Island
- Women & Infants Hospital of Rhode Island - Providence
Virginia
- Virginia Cancer Specialists - Fairfax
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2020-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03195192
The ClinicalTrials.gov registry entry for NCT03195192 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (86% lower). The listed sponsor is Side-Out Foundation, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which biomarker study is the first listed.
NCT03195192 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT03195192 about?
NCT03195192 is a clinical study titled "Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer". This is an open-label, multicenter study in patients with metastatic breast cancer who are candidates for standard first line treatment with palbociclib or ribociclib plus endocrine therapy. To be eligible, patients must have received no prior chemotherapeutic or hormonal regimen for metastatic dise...
What is the current status of trial NCT03195192?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2017-03-09. Estimated completion is 2020-06-30.
What conditions does trial NCT03195192 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT03195192?
The interventions under investigation include: biomarker study (OTHER).
Who is sponsoring clinical trial NCT03195192?
This trial is sponsored by Side-Out Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03195192 being conducted?
This trial has 8 study locations across Alabama, California, Florida, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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