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CDK 4/6 Inhibitor

Single arm for Breast Cancer

N/A
Waitlist Available
Research Sponsored by Side-Out Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate baseline phosphorylated RB levels in tumor tissue as a predictive marker of response to palbociclib or ribociclib as first line treatment for ER+/HER2- metastatic breast cancer
Secondary study objectives
Determine frequency when "multi-omic" profiling: proteomic and genomic profiling analysis of patient's tumor yields a target against which there is an FDA-approved agent or therapeutic regimen.
Determine percent of time multiomic profiling based treatment recommendation is different than treatment selected by the patient's physician once a patient shows progression after first line treatment with palbociclib or ribociclib
Evaluate baseline biomarkers which are direct substrates of CDK 4/6 or controlled secondarily by CDK 4/6 kinase activity as qualifying predictive markers of response to CDK 4/6 inhibitors as first line treatment for ER+/HER2- metastatic breast cancer
+2 more
Other study objectives
Perform RPPA based batch analysis of all samples at the end of this study to measure 50-100 protein signaling targets. Protein activation will be correlated with clinical response.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
This is a biomarker study analyzing tissue for baseline biomarkers and collecting tissue at progression for further analysis of biomarkers changes after treatment with CDK 4/6 inhibitors and endocrine therapy

Find a Location

Who is running the clinical trial?

Side-Out FoundationLead Sponsor
2 Previous Clinical Trials
53 Total Patients Enrolled
Translational Drug DevelopmentOTHER
18 Previous Clinical Trials
976 Total Patients Enrolled
3 Trials studying Breast Cancer
216 Patients Enrolled for Breast Cancer
~3 spots leftby Nov 2025