Breast Cancer
A Study of Ruxolitinib in Combination with Capecitabine in Subjects with Advanced or Metastatic HER2-negative Breast Cancer
Incyte Study ID:
INCB 18424-268
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
May 2014 - Feb 2016
TYPE
Interventional
PHASE
Phase 2
SEX
Female only
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
Birmingham, AL, US
Status
Recruiting
Location
Chandler, AZ, US
Status
Recruiting
Location
Sedona, Arizona, US
Status
Recruiting
Location
La Jolla, California, US
Status
Recruiting
Location
Los Angeles, CA, US
Status
Recruiting
Location
Oxnard, CA, US
Status
Recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
- Locally advanced (Stage 3B) or metastatic (Stage 4) disease
Exclusion Criteria
- Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
- Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
Protocol Summary
Incyte Study ID:
INCB 18424-268
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Interventions:
Drug
Enrollment:
149
Primary Outcome
Open
Secondary Outcome
Open