Spots Global Cancer Trial Database for Ruxolitinib in Patients With Breast Cancer

Study Description

Brief Summary: Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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