Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT06008275
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neratinib Oral Tablet — DRUG
    240mg oral daily. Dosing will follow standard dose escalation procedures
  • Ruxolitinib Oral Tablet — DRUG
    20mg oral twice daily. Dosing will follow standard initial dose recommendation procedure

Study Details

The goal of this clinical trial is to assess the safety and efficacy of combined ruxolitinib and neratinib in patients with chemotherapy-pretreated metastatic triple negative breast cancer. This trial will evaluate one dosing schedule of neratinib in ruxolitinib in patients with metTNBC with locoregional recurrence.

Key Dates

Start date
Sep 16, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: neratinib + ruxolitinib
    There is only one arm

Primary Outcome Measure

Objective Response Rate [ Time Frame: 18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical Center, Baylor Charles A Sammons Cancer CenterDallasTexas75246
Page E Blas, MA
214-820-5424
Joyce A O'Shaughnessy, MD (PRINCIPAL_INVESTIGATOR)

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