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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

Description

This 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.

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 - 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

Sites

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