Conditions: Breast Cancer
Keywords: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 149
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ruxolitinib intervention 2: Capecitabine intervention 3: Placebo
Intervention descriptions: intervention 1: 5 mg tablets to be administered by mouth

Ruxolitinib 15 mg BID (starting dose) intervention 2: Capecitabine 2000 mg/m\^2 daily given as 1000 mg/m\^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle intervention 3: 5 mg matching placebo tablets to be administered by mouth

Protocol document: