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

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• 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

• Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate

• ≥ 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. modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L

2. mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

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)

• Unknown hormone-receptor status

• Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment

• Concurrent anticancer therapy

• Inadequate renal, hepatic or bone marrow function

• Another current or previous malignancy within 2 years of study entry unless approved by the sponsor