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



Status:Terminated
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/15/2018
Start Date:May 2014
End Date:January 2017

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A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer

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.


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
We found this trial at
81
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