1B-14-3 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
DescriptionThis is a randomized, double-blind, placebo controlled clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who receive treatment with capecitabine in combination with ruxolitinib versus those who receive treatment with capecitabine alone.
PhasePhase 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 - Subjects with hormone-receptor positive tumors must have failed available appropriate lines of hormonal therapy - ≥ 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:
- mGPS of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
- mGPS of 2: CRP > 10 mg/L and albumin < 35 g/L
- Received prior treatment with capecitabine for metastatic disease
- Received more than 2 prior chemotherapy regimens for advanced or metastatic disease (not including neoadjuvant/adjuvant therapy)
- Unknown hormone-receptor status
- Ongoing radiation therapy, radiation therapy administered within 2 weeks of enrollment
- Inadequate renal, hepatic or bone marrow function
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.