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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This is a randomized, double-blind, placebo controlled clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who receive treatment with capecitabine in combination with ruxolitinib versus those who receive treatment with capecitabine alone.

Official Title

A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer

Keywords

Advanced or Metastatic HER2-negative Breast Cancer Breast Cancer Capecitabine

Eligibility

You can join if…

Open to females ages 18 years and up

  • Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
  • Locally advanced (Stage 3B) or metastatic (Stage 4) disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
  • Subjects with hormone-receptor positive tumors must have failed available appropriate lines of hormonal therapy
  • ≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
  • Radiographically measurable or evaluable disease
  • An mGPS of 1 or 2 as defined below:
  • Criteria:

    1. mGPS of 1: CRP> 10 mg/L and albumin ≥ 35 g/L
    2. mGPS of 2: CRP> 10 mg/L and albumin < 35 g/L

You CAN'T join if...

  • Received prior treatment with capecitabine for metastatic disease
  • Received more than 2 prior chemotherapy regimens for advanced or metastatic disease(not including neoadjuvant/adjuvant therapy)
  • Unknown hormone-receptor status
  • Ongoing radiation therapy, radiation therapy administered within 2 weeks of enrollment
  • Inadequate renal, hepatic or bone marrow function

Locations

  • San Francisco, California, United States
  • Oxnard, California, United States
  • Santa Monica, California, United States
  • Los Angeles, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02120417
Phase
Phase 2
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
September 1, 2016