Recruitment

Recruitment Status
Terminated
Estimated Enrollment
148

Inclusion Criteria

mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
≥ 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
...
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
≥ 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
modified Glasgow prognostic score (mGPS) of 1: 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
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
Locally advanced (Stage 3B) or metastatic (Stage 4) disease

Exclusion Criteria

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
Inadequate renal, hepatic or bone marrow function
...
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
Inadequate renal, hepatic or bone marrow function
Concurrent anticancer therapy
Unknown hormone-receptor status
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease

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

mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
≥ 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
...
mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
≥ 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
modified Glasgow prognostic score (mGPS) of 1: 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
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
Locally advanced (Stage 3B) or metastatic (Stage 4) disease

Exclusion Criteria

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
Inadequate renal, hepatic or bone marrow function
...
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
Inadequate renal, hepatic or bone marrow function
Concurrent anticancer therapy
Unknown hormone-receptor status
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease

Tracking Information

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