We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ruxolitinib in Patients With Breast Cancer

This study has been terminated.
(Not enough responses to continue treatment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562873
First Posted: March 26, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute
March 20, 2012
March 26, 2012
October 5, 2016
February 23, 2017
February 23, 2017
June 2012
June 2015   (Final data collection date for primary outcome measure)
Objective Response Rate [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5). ]
The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Objective response by RECIST 1.1 [ Time Frame: 2 years ]
Objective response by RECIST 1.1
Complete list of historical versions of study NCT01562873 on ClinicalTrials.gov Archive Site
  • Clinical Benefit Rate [ Time Frame: Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5). ]
    Clinical benefit rate (CBR) was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.
  • Overall Survival [ Time Frame: In long-term follow-up, patients were followed for survival every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9). ]
    Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.
  • Progression-Free Survival [ Time Frame: Disease was evaluated radiologically every 8 weeks on treatment through 12 cycles and in long-term follow-up every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9). ]
    Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.
  • Toxicity Profile [ Time Frame: 2 years ]
    Describe the grade and frequency of adverse events according to CTCAE v4.0 in patients treated with ruxolitinib
  • Clinical Benefit Rate [ Time Frame: 2 years ]
    CR+PR+SD greater than or equal to 24 weeks
  • Progression-Free Survival [ Time Frame: 2 years ]
    Describe progression-free survival (time from study entry to progression or death, whichever comes first)
  • Overall Survival [ Time Frame: 2 years ]
    Describe overall survival (time from study entry to death due to any cause) in study participants
Not Provided
Not Provided
 
Ruxolitinib in Patients With Breast Cancer
Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer
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.

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
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: Ruxolitinib
Other Names:
  • INCB018424
  • Jakafi
  • Experimental: Ruxolitinib-Cohort A
    Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
    Intervention: Drug: Ruxolitinib
  • Experimental: Ruxolitinib-Cohort B
    Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
    Intervention: Drug: Ruxolitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
June 2016
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancer
  • Must have known ER, PR and HER2 status
  • Either, Triple Negative Metastatic Breast Cancer or
  • Inflammatory Breast Cancer with any ER, PR HER2 status
  • Availability of archival tissue specimen suitable for pStat3 testing
  • Life expectancy of greater than 3 months
  • Measurable disease by RECIST
  • At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
  • For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Active brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
  • Clinically significant malabsorption syndrome
  • Concurrent use of medications/substances that are strong inhibitors of CY3A4
  • No uncontrolled intercurrent illness
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01562873
12-024
Yes
Not Provided
Plan to Share IPD: No
Nancy Lin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Not Provided
Not Provided
Dana-Farber Cancer Institute
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP