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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
Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)
Total bilirubin =< 1.5 x upper limit normal (ULN) (obtained =< 7 days prior to registration)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing the side effects and best dose of a drug when given with another drug to treat stage IV triple negative breast cancer.

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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have an advanced type of breast cancer that has spread to other parts of the body and has not responded to at least one round of chemotherapy, or you have chosen not to receive chemotherapy. The cancer can also be in your bones.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose
Secondary outcome measures
Best response
Other outcome measures
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
~2030
Ruxolitinib Phosphate
2011
Completed Phase 2
~380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,486 Previous Clinical Trials
41,265,925 Total Patients Enrolled
934 Trials studying Breast Cancer
1,540,727 Patients Enrolled for Breast Cancer
Mayo ClinicLead Sponsor
3,112 Previous Clinical Trials
3,502,888 Total Patients Enrolled
83 Trials studying Breast Cancer
14,089 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Ruxolitinib Phosphate for public consumption?

"With limited clinical evidence of efficacy and safety, our team at Power assigned Ruxolitinib Phosphate a score of 1 on the risk assessment scale."

Answered by AI

How many participants has this medical trial recruited thus far?

"Affirmative. According to the info available on clinicaltrials.gov, this trial is actively enrolling participants with its first posting being on December 6th 2017 and most recent update occurring on October 21st 2022. 18 patients from a single site are expected to join the study."

Answered by AI

What precedent has been set for Ruxolitinib Phosphate in clinical research?

"A comprehensive search of clinical trials.gov reveals 1058 registered studies researching Ruxolitinib Phosphate, with 134 in their late stages of development. The majority are based around Houston, Texas; however there are 38968 locations across the globe currently running these tests."

Answered by AI

Is this research study still welcoming new participants?

"According to the information made available on clinicaltrials.gov, this study is actively searching for participants. It was initially published in December of 2017 and underwent its most recent revision in October of 2022."

Answered by AI

What medical conditions is Ruxolitinib Phosphate prescribed to alleviate?

"Patients with unresectable melanoma, high microsatellite instability and a heightened risk of recurrence may benefit from Ruxolitinib Phosphate treatment."

Answered by AI
~2 spots leftby Nov 2024