Recruitment

Recruitment Status
Terminated
Estimated Enrollment
148

Inclusion Criteria

modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
...
modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
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
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria

Concurrent anticancer therapy
Inadequate renal, hepatic or bone marrow function
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
...
Concurrent anticancer therapy
Inadequate renal, hepatic or bone marrow function
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
Unknown hormone-receptor status
Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Inclusion Criteria

modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
...
modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
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
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

Exclusion Criteria

Concurrent anticancer therapy
Inadequate renal, hepatic or bone marrow function
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
...
Concurrent anticancer therapy
Inadequate renal, hepatic or bone marrow function
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
Unknown hormone-receptor status
Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment

Locations

Birmingham, Alabama
Hialeah, Florida
Kalamazoo, Michigan
Lecco
Middletown, Ohio
...
Birmingham, Alabama
Hialeah, Florida
Kalamazoo, Michigan
Lecco
Middletown, Ohio
La Roche Sur Yon
Kingston Upon Thames
Milwaukee, Wisconsin
Kansas City, Missouri
Jaén
Ogden, Utah
Oxnard, California
Cleveland, Ohio
Seattle, Washington
Canton, Ohio
New Haven, Connecticut
Louisville, Kentucky
Urbana, Illinois
La Jolla, California
A Coruña
Baltimore, Maryland
Barcelona
Taunton
Truro
Grand Island, Nebraska
Saint Petersburg, Florida
Fort Worth, Texas
Alba
Baton Rouge, Louisiana
Foggia
Yeovil
Hackensack, New Jersey
Santa Monica, California
Chattanooga, Tennessee
Houston, Texas
Paris Cedex 10
Naples
Fano
Saronno
Tyler, Texas
Fairfax, Virginia
Plantation, Florida
Plano, Texas
Minneapolis, Minnesota
Germantown, Tennessee
Bronx, New York
Philadelphia, Pennsylvania
Glasgow
Paris
Marietta, Georgia
Roma
Arlington, Texas
Quincy, Illinois
Cincinnati, Ohio
Omaha, Nebraska
Denver, Colorado
Wichita, Kansas
Albany, New York
McAllen, Texas
Sutton
Pittsburgh, Pennsylvania
Miami, Florida
Detroit, Michigan
Salem, Virginia
Nottingham
Cardiff
Green Bay, Wisconsin
Richmond, Virginia
Portland, Oregon
Charleston, South Carolina
Norfolk, Virginia
El Paso, Texas
San Diego, California
Lisbon
Nashville, Tennessee
Salt Lake City, Utah
Bedford, Texas
Lleida
Johnson City, New York
Farmington, New Mexico
Tampa, Florida
Milano
Greenville, South Carolina
Aurora, Colorado
Chicago, Illinois
Camden, New Jersey
Goldsboro, North Carolina
New York, New York
Columbus, Ohio
Fort Myers, Florida
Atlanta, Georgia
Bethlehem, Pennsylvania
Pontedera
Saint Louis, Missouri
Springfield, Illinois
London
Los Angeles, California
Pinehurst, North Carolina
Duluth, Minnesota
Sedona, Arizona
Chandler, Arizona
Ames, Iowa
Madrid
Dallas, Texas
Savannah, Georgia
San Francisco, California
Washington, District of Columbia

Tracking Information

NCT #
NCT02120417
Collaborators
Not Provided
Investigators
Study Director: Gerard Kennealey, MD Incyte Corporation