Neratinib in Combination With Ruxolitinib in Patients With mTNBC

NCT06008275 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 023-340
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Triple-Negative Breast Carcinoma; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Calculate objective response rate (CR+PR) associated with neratinib in combination ruxolitinib. Objective response rate will be calculated by defining the proportion of patients who have a complete or partial response to the study therapy, as determined by the treating physician.

  18 months

Secondary Outcomes (1)

• Duration of Response

  18 months

Other Outcomes (1)

• Genetic Evaluation

  18 months

Study Arms (1)

neratinib + ruxolitinib

EXPERIMENTAL

There is only one arm

Drug: Neratinib Oral Tablet; Drug: Ruxolitinib Oral Tablet

Interventions

Neratinib Oral Tablet DRUG

240mg oral daily. Dosing will follow standard dose escalation procedures

neratinib + ruxolitinib

Ruxolitinib Oral Tablet DRUG

20mg oral twice daily. Dosing will follow standard initial dose recommendation procedure

Also known as: Jakafi

neratinib + ruxolitinib

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient will be considered for enrollment in this study if all the following criteria are met:
• Female patients ≥18 years of age
• Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required.
• Note. TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020.
• Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1.
• Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Have adequate hematologic function, defined by:
• Absolute neutrophil count (ANC) \>1500/µL
• Platelet count ≥100,000/ µL
• Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
• Have adequate liver function, defined by:
• AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases
• Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5 × ULN
• Have adequate renal function, defined by:

You may not qualify if:

• Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed.
• Has peripheral neuropathy ≥grade 2
• Has completed previous radiotherapy for metastatic disease \<2 weeks prior to study treatment initiation
• Has an active infection requiring systemic therapy
• Has significant cardiovascular disease, such as:
• History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the last 6 months
• Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.
• Has a known history of active tuberculosis
• Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
• severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air
• liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Treating Physician.
• Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment.
• Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

neratinib; ruxolitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joyce A O'Shaughnessy, MD

  Baylor Scott and White Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Page E Blas, MA

CONTACT

214-820-5424; page.blas@bswhealth.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: September 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)