A Study of Ruxolitinib in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-negative Breast Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 148
Inclusion Criteria
- Radiographically measurable or evaluable disease
- 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
- ...
- Radiographically measurable or evaluable disease
- 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
- Locally advanced (Stage 3B) or metastatic (Stage 4) 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- 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
Exclusion Criteria
- Inadequate renal, hepatic or bone marrow function
- Unknown hormone-receptor status
- Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
- ...
- Inadequate renal, hepatic or bone marrow function
- Unknown hormone-receptor status
- Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
- Concurrent anticancer therapy
- Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
- 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)
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
- Radiographically measurable or evaluable disease
- 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
- ...
- Radiographically measurable or evaluable disease
- 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
- Locally advanced (Stage 3B) or metastatic (Stage 4) 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- 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
Exclusion Criteria
- Inadequate renal, hepatic or bone marrow function
- Unknown hormone-receptor status
- Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
- ...
- Inadequate renal, hepatic or bone marrow function
- Unknown hormone-receptor status
- Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
- Concurrent anticancer therapy
- Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
- 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)
Tracking Information
- NCT #
- NCT02120417
- Collaborators
- Not Provided
- Investigators
- Study Director: Gerard Kennealey, MD Incyte Corporation
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