Recruitment

Recruitment Status
Terminated
Estimated Enrollment
148

Inclusion Criteria

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

Exclusion Criteria

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

Exclusion Criteria

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
...
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
Unknown hormone-receptor status
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
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