Spots Global Cancer Trial Database for Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
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Trial Identification
Brief Title: Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
Official Title: Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra Plus the Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients
Study ID: NCT01802970
Conditions
Interventions
Study Description
Brief Summary: To determine the safety of administering anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with metastatic breast cancer (MBC), as well as determining blood immune cell transcriptional signatures in patients who undergo IL-1 receptor blockade.
Detailed Description: In an attempt to reverse the immune suppressive microenvironment and to enhance chemotherapy effectiveness, decrease tumor metagenicity and decrease IL-1-induced fatigue, metastatic breast cancer (MBC) patients will be treated with chemotherapy plus anakinra. This is a pilot safety, single arm, open label trial. The objective is to determine the safety of anakinra plus the physician's chemotherapy choice (TPC) of nab paclitaxel, capecitabine, eribulin, or vinorelbine in patients with MBC and to define an anakinra-induced anti-IL-1 whole blood transcriptional profile.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Baylor University Medical Center, Dallas, Texas, United States
Contact Details
Name: Joyce O'Shaughnessy, MD
Affiliation: Baylor Health Care System
Role: PRINCIPAL_INVESTIGATOR
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