Brief Summary
This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine alone.
Brief Title
A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Breast Cancer
Eligibility Criteria
Inclusion 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
* Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
* ≥ 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:
1. modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
2. mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L
Exclusion Criteria:
* Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
* Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
* Unknown hormone-receptor status
* Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
* Concurrent anticancer therapy
* Inadequate renal, hepatic or bone marrow function
* Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
* 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
* Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
* ≥ 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:
1. modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
2. mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L
Exclusion Criteria:
* Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
* Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
* Unknown hormone-receptor status
* Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
* Concurrent anticancer therapy
* Inadequate renal, hepatic or bone marrow function
* Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Inclusion Criteria
Inclusion 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
* Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
* ≥ 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:
1. modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
2. mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L
* 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
* Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
* ≥ 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:
1. modified Glasgow prognostic score (mGPS) of 1: CRP \> 10 mg/L and albumin ≥ 35 g/L
2. mGPS of 2: C-reactive protein (CRP) \> 10 mg/L and albumin \< 35 g/L
Gender
Female
Gender Based
false
Keywords
Breast Cancer
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02120417
Org Class
Industry
Org Full Name
Incyte Corporation
Org Study Id
INCB 18424-268
Overall Status
Terminated
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Outcome Description
Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Outcome Measure
Median Survival
Outcome Time Frame
Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Outcome Description
Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Outcome Measure
Percentage of Participants Achieving Overall Survival
Outcome Time Frame
Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
Secondary Outcomes
Outcome Description
Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.
Outcome Time Frame
Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
Outcome Measure
Progression-free Survival (PFS)
Outcome Description
Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Outcome Time Frame
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Outcome Measure
Percentage of Participants Achieving Objective Response Rate
Outcome Description
The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Outcome Time Frame
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Outcome Measure
Duration of Response (DOR)
Outcome Description
Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.
Outcome Time Frame
Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Outcome Measure
Percentage of Participants Achieving Clinical Benefit Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Phone