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Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra plus The Physician’s Chemotherapy Choice in Metastatic Breast Cancer Patients

Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra plus The Physician’s Chemotherapy Choice in Metastatic Breast Cancer Patients (IRB 012-099)

Study Description:

The objective of this protocol is to treat metastatic breast cancer patients with nab paclitaxel chemotherapy plus anakinra, to reverse the immunosuppressive microenvironment and to enhance chemotherapy effectiveness and decrease tumor progression. This study will also evaluate whether anakinra can improve the proinflammatory immune cell program present in patients with MBC.

Inclusion Criteria:

» Female or male patients ≥18 years of age.
» Histologically confirmed invasive breast cancer, locally unresectable or metastatic.
» No more than 2 prior chemotherapy regimens for metastatic disease.
» Prior hormonal therapy in the adjuvant or metastatic setting is permitted. Estrogen receptor positive patients should be considered candidates for chemotherapy.
» HER2-negative breast cancer. If HER2-, it is defined as follows: a. FISH-negative (FISH ratio <2.0), or b. IHC 0-1+, or c. IHC 2+ AND FISH-negative (FISH ratio<2.0)
» Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
» Adequate hematologic function, defined by: a. Absolute neutrophil count (ANC) >1500/mm3; b. Platelet count ≥100,000/mm3; c. Hemoglobin >8 g/dL
» Adequate liver function, defined by: a. AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of liver metastases; b. Total bilirubin ≤1.5 x ULN
» Adequate renal function, defined by: a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥40 ml/min
» International normalized ratio (INR) ≤1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy). Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin are eligible if the INR is stable and within the therapeutic range prior to study treatment initiation.
» Measurable or nonmeasurable disease by RECIST v1.1 criteria
» Life expectancy ≥24 weeks
» Adequate recovery from recent surgery: a. Major surgical procedure >28 days from study entry; b. Minor surgical procedure >7 days from study entry (Portacath placement accepted – patients can start treatment <7 days after portacath placement.)
» Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
» Patient must be accessible for treatment and follow-up.
» All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry

Exclusion Criteria:

» Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms <Grade 2; 2) no dexamethasone requirement; and 3) follow-up MRI shows decrease in the size the lesions after treatment and no new lesions appearing.
» Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.
» Patients who are currently receiving systemic cancer therapy or have received previous systemic therapy within 2 weeks of the start of study drug (eg, chemotherapy, antibody therapy, targeted agents).
» Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
» Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as: a. severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air; b. uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN; c. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
» History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.
» Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
» Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
» Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.


Baylor Charles A. Sammons Cancer Center
3410 Worth Street
Dallas , TX 75246

Lead Principal Investigator:

Dr. Joyce O'Shaughnessy

For further information regarding this study, please contact the Office of Clinical Oncology Research Coordination at 214-818-8472 or via email at

Last update: January 15, 2012