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Ruxolitinib in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT01562873
Recruitment Status : Terminated (Not enough responses to continue treatment.)
First Posted : March 26, 2012
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Ruxolitinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from October 2012 through June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients must have had sufficient archival specimen for central pStat3 testing to be eligible.

Reporting Groups
  Description
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).
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).

Participant Flow:   Overall Study
    Ruxolitinib-Cohort A   Ruxolitinib-Cohort B
STARTED   21   0 [1] 
COMPLETED   0   0 
NOT COMPLETED   21   0 
Disease Progression per RECIST                10                0 
Adverse Event                1                0 
Clinical Disease Progression                9                0 
Clinical PD and adverse event                1                0 
[1] The observed number of objective responses in Cohort A was not sufficient for Cohort B to open.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The analysis dataset is comprised of all treated patients.

Reporting Groups
  Description
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).

Baseline Measures
   Ruxolitinib-Cohort A 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Median (Full Range)
 51 
 (36 to 72) 
Gender 
[Units: Participants]
Count of Participants
 
Female      21 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   21 
pStat3 Positive Status 
[Units: Participants]
 
moderate to high positive   21 
low positive   0 


  Outcome Measures

1.  Primary:   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). ]

2.  Secondary:   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). ]

3.  Secondary:   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). ]

4.  Secondary:   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). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nancy Lin, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.2335
e-mail: Nancy_Lin@dfci.harvard.edu



Responsible Party: Nancy Lin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01562873     History of Changes
Other Study ID Numbers: 12-024
First Submitted: March 20, 2012
First Posted: March 26, 2012
Results First Submitted: October 5, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017