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Tyrosine Kinase Inhibitor

Neratinib + Ruxolitinib for Breast Cancer

Q: How can someone avail themselves of this clinical exploration?

<p>This research is no longer enrolling participants as per the clinicaltrials.gov website; it was initially posted on November 1st 2023 and last edited August 22nd 2023. However, there are currently 2717 other medical trials that require patients' participation.</p>

Phase < 1

Waitlist Available

Led By Joyce A O'Shaughnessy, MD

Research Sponsored by Baylor Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or 'ER Low Positive' as defined by the updated ASCO/CAP guidelines 2020

History of brain metastasis with specific criteria met

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will test if two drugs together can help treat metastatic triple negative breast cancer after chemotherapy.

Who is the study for?

This trial is for women over 18 with metastatic triple-negative breast cancer (mTNBC) previously treated with specific chemotherapies. Participants must have adequate organ function and cannot be pregnant or breastfeeding. They should not have had more than four prior chemotherapy regimens, though exceptions may apply based on physician discretion.Check my eligibility

What is being tested?

The trial tests the combination of two oral medications, ruxolitinib and neratinib, in patients with mTNBC who've had previous chemotherapy. It aims to determine the safety and effectiveness of this treatment regimen for those experiencing a recurrence of their cancer.See study design

What are the potential side effects?

Potential side effects from ruxolitinib include anemia, low platelet count, dizziness, headache, and increased risk of infection. Neratinib can cause diarrhea, liver enzyme elevation, rash, nausea and vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is triple-negative or has very low estrogen receptors.

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I have had brain metastasis but meet specific health criteria.

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My kidney function is within the required range.

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My liver is functioning within the required limits.

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I am a woman aged 18 or older.

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I am fully active or have some restrictions but can still care for myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate

Secondary outcome measures

Duration of Response

Other outcome measures

Genetic Evaluation

Trial Design

1Treatment groups

Experimental Treatment

Group I: neratinib + ruxolitinibExperimental Treatment2 Interventions

There is only one arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib Oral Tablet

2016

Completed Phase 2

~160

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor Research InstituteLead Sponsor

200 Previous Clinical Trials

203,401 Total Patients Enrolled

3 Trials studying Breast Cancer

230 Patients Enrolled for Breast Cancer

Joyce A O'Shaughnessy, MDPrincipal InvestigatorBaylor Scott and White Research Institute

4 Previous Clinical Trials

3,184 Total Patients Enrolled

1 Trials studying Breast Cancer

3,000 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

How can someone avail themselves of this clinical exploration?

"This research is no longer enrolling participants as per the clinicaltrials.gov website; it was initially posted on November 1st 2023 and last edited August 22nd 2023. However, there are currently 2717 other medical trials that require patients' participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

2023. "Neratinib in Combination With Ruxolitinib in Patients With mTNBC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008275.