Ruxolitinib in Patients With Breast Cancer

Objectives:

Primary

The primary objective of this two-stage, phase II study is to estimate the objective response rate to ruxolitinib in patients with metastatic or unresectable locally advanced breast cancer which is pStat3+ and which has progressed on at least one line of chemotherapy for advanced disease, and/or has recurred within 12 months of completion of neoadjuvant/adjuvant chemotherapy.

Secondary

To describe the toxicity profile
To evaluate clinical benefit rate (CR + PR + SD >/= 24 weeks)
To estimate progression-free and overall survival

Exploratory

To explore whether baseline hs-CRP level higher than the group median is associated with objective response
To explore whether baseline IL-6 level higher than the group median is associated with objective response
To describe hs-CRP level over time, and to describe the proportion of patients with a) hs-CRP > 3mg/L at baseline, on treatment, and at time of progression, and b) hs-CRP > 1mg/L at baseline, on treatment, and at time of progression
To describe IL-6 level over time, and to describe the proportion of patients with IL-6 level above the upper limit of normal at baseline, on treatment, and at time of progression
To describe pStat3 status by IHC in baseline metastatic biopsies
To describe pStat3 status by IHC in on-study biopsies
To describe pStat3 status by IHC in the time of progression biopsy samples
To characterize archival and metastatic biopsy samples using triple immunofluorescence for CD44, CD24, and pStat3
To characterize archival and metastatic biopsy samples using a previously characterized pStat3 gene signature
To characterize circulating tumor cells (CTCs) for CD44, CD24, and pStat3 at baseline and time of progression