Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Metastatic Breast Cancer, sponsored by Side-Out Foundation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Establish baseline values in tumor tissue to use as predictive markers
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 |
What the finished NCT03195192 record still lists
NCT03195192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (86% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03195192's enrollment target sits among peer trials
28 110th of 139 higher than 29 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer
RECRUITING · NA
-
Adaptation of a Values Assessment Tool
RECRUITING · NA
-
Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
RECRUITING · NA
-
Targeted Palliative Care Intervention for Patients With Metastatic Breast Cancer
RECRUITING · NA
-
Feasibility of Symptom Management for Patients With Metastatic Breast Cancer to Increase Exercise
RECRUITING · NA
-
Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI