Recruitment

Recruitment Status
Terminated
Estimated Enrollment
148

Inclusion Criterias

mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Radiographically measurable or evaluable disease
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
...
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Radiographically measurable or evaluable disease
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
≥ 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
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

Exclusion Criterias

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

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 Criterias

mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Radiographically measurable or evaluable disease
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
...
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
Radiographically measurable or evaluable disease
Locally advanced (Stage 3B) or metastatic (Stage 4) disease
modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
≥ 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
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

Exclusion Criterias

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

Locations

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

Tracking Information

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