Clinical trial NCT02120417: A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
measure: Median Survival
timeFrame: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
measure: Percentage of Participants Achieving Overall Survival
timeFrame: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.
measure: Percentage of Participants Achieving Objective Response Rate
timeFrame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
measure: Duration of Response (DOR)
timeFrame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
measure: Percentage of Participants Achieving Clinical Benefit Rate
timeFrame: Randomization through end of study up to 19 months or the data cutoff 08FEB2016.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Sedona
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oxnard
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Fort Myers
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Quincy
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Urbana
country: United States
state: Illinois
city: Ames
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Baton Rouge
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Grand Island
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: Hackensack
country: United States
state: New Jersey
city: Farmington
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Johnson City
country: United States
state: New York
city: New York
country: United States
state: New York
city: Goldsboro
country: United States
state: North Carolina
city: Pinehurst
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Green Bay
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: La Roche Sur Yon
country: France
city: Paris Cedex 10
country: France
city: Paris
country: France
city: Alba
country: Italy
city: Fano
country: Italy
city: Foggia
country: Italy
city: Lecco
country: Italy
city: Milano
country: Italy
city: Naples
country: Italy
city: Pontedera
country: Italy
city: Roma
country: Italy
city: Saronno
country: Italy
city: Lisbon
country: Portugal
city: A Coruña
country: Spain
city: Barcelona
country: Spain
city: Jaén
country: Spain
city: Lleida
country: Spain
city: Madrid
country: Spain
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Kingston Upon Thames
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sutton
country: United Kingdom
city: Taunton
country: United Kingdom
city: Truro
country: United Kingdom
city: Yeovil
country: United Kingdom
Study officials:
affiliation: Incyte Corporation
name: Gerard Kennealey, MD
role: STUDY_DIRECTOR
References: