Safety and Blood Immune Cell Study of Anakinra Plus Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

January 4, 2017

Study Completion Date

January 4, 2017

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Anakinra plus Standard of Care

Patients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m\^2 Intravenous on day 1,8 \&15 of a 28 day cycle), or capecitabine (1000mg/m\^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m\^2 intravenous on day 1 \& 8 of a 21 day cycle), or vinorelbine (25mg/m\^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity.

Trial Locations (1)

75246

Baylor University Medical Center, Dallas

Sponsors
All Listed Sponsors
lead

Baylor Research Institute

OTHER