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

Incyte

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Ruxolitinib; Drug: Placebo; Drug: Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120417

INCB 18424-268

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups

Treatment A - Capecitabine and ruxolitinib

Experimental group

Treatment:

Drug: Capecitabine

Drug: Ruxolitinib

Treatment B - Capecitabine and placebo

Active Comparator group

Treatment:

Drug: Placebo

Drug: Capecitabine