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
Description
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.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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:
- 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Powered by
SC CTSI