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Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer

NCT02066532 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-08-24

Study results available
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Summary

The purpose of this study is to examine the safety and efficacy of Ruxolitinib in combination with Trastuzumab in treatment of HER2 positive metastatic breast cancer. Ruxolitinib (Jakafi) is an Food and Drug Administration (FDA) approved treatment for myelofibrosis (a disease of the bone marrow), but its safety and efficacy in breast cancer patients is not known. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer. The safety and efficacy of both treatments given in combination is not known. It is hypothesized that Ruxolitinib in combination with Trastuzumab will demonstrate efficacy in treating Metastatic HER2 Positive Breast Cancer subjects, and will have a tolerable safety profile in this patient population.

Conditions

Interventions

DRUG

Ruxolitinib

25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

Trastuzumab

6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab \> 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Dawn L. Hershman

    lead OTHER

Principal Investigators

  • Dawn Hershman, MD, MS · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2020-10-14
Completion
2020-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02066532 on ClinicalTrials.gov