A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer

Summary

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.

Timeline

Start

2014-05

Primary completion

2016-02

Completion

2017-01

Outcome

Missed primary endpoint

Stopped: “The study was terminated as other related studies of ruxolitinib did not provide sufficient efficacy to warrant continuation.”

registry p = 0.762; Hazard Ratio (HR) 0.932 (80% CI 0.694 to 1.252); Log Rank NCT02120417 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	15 mg	Oral
Background	Capecitabine	Small molecule	1000 mg/m2	—

Indications