Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Dawn L. Hershman
Study ID
NCT02066532
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ruxolitinib — DRUG
    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.
  • Trastuzumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2014
Status verified
Aug 2023
Primary completion
Oct 14, 2020
Completion
Oct 14, 2020

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib/Trastuzumab
    Jakafi (Ruxolitinib) and Trastuzumab (Herceptin) - 21 day cycle until disease progression

Primary Outcome Measure

Maximum Tolerated Dose of Ruxolitinib in Combination With Trastuzumab (Phase I) [ Time Frame: Up to 15 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-
Montefiore Medical CenterNew YorkNew York10461-
Mount Sinai Medical CenterNew YorkNew York10029-
New York Hospital-Weill Cornell Medical CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University Medical Center· New York, NYMontefiore Medical Center· New York, NYMount Sinai Medical Center· New York, NYNew York Hospital-Weill Cornell Medical Center· New York, NY

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