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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02120417

Run by

Incyte Corporation

People needed

149

Starts

2014-05-01

Expected to finish

2017-01-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
• mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L

You may not qualify if…

• 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

Where it is running

• Study site — Chandler, Arizona, United States
• Study site — Sedona, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oxnard, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Monica, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Fort Myers, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Quincy, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.