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Checkpoint Inhibitor

Pembrolizumab for Breast Cancer

Phase 1
Waitlist Available
Led By Donald W Northfelt
Research Sponsored by Mayo Clinic
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 up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of two drugs for advanced breast cancer. It targets patients with a specific, hard-to-treat type of breast cancer. The drugs work by boosting the body's natural defenses against cancer and stopping cancer cell growth.

Eligible Conditions
  • Triple Negative Breast Cancer
  • Breast cancer
  • Bone Metastasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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
Incidence of adverse events
Maximum tolerated dose
Secondary study objectives
Best response
Other study objectives
Assessment of PDJ amplification, PD-L1, PD-L2, JAK2 expression and pSTAT3

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: Treatment (pembrolizumab, ruxolitinib phosphate)Experimental Treatment3 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1 and ruxolitinib phosphate PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Ruxolitinib Phosphate
2011
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,924 Previous Clinical Trials
41,017,939 Total Patients Enrolled
942 Trials studying Breast Cancer
1,443,237 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,061,162 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
Donald W NorthfeltPrincipal InvestigatorMayo Clinic

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03012230 — Phase 1
Breast Cancer Research Study Groups: Treatment (pembrolizumab, ruxolitinib phosphate)
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03012230 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03012230 — Phase 1
~2 spots leftby Nov 2025