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

Exclusion Criteria

Inadequate renal, hepatic or bone marrow function
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)
...
Inadequate renal, hepatic or bone marrow function
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)
Concurrent anticancer therapy
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Unknown hormone-receptor status

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

Exclusion Criteria

Inadequate renal, hepatic or bone marrow function
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)
...
Inadequate renal, hepatic or bone marrow function
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)
Concurrent anticancer therapy
Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
Unknown hormone-receptor status

Tracking Information

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