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Checkpoint Inhibitor
Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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
~3150
Ruxolitinib Phosphate
2011
Completed Phase 2
~390
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,158 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,011 Total Patients Enrolled
84 Trials studying Breast Cancer
14,796 Patients Enrolled for Breast Cancer
Donald W NorthfeltPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, ruxolitinib phosphate)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.