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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

Phase 1
18 Years
80 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

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

In an attempt to reverse the immune suppressive microenvironment and to enhance chemotherapy
effectiveness and decrease tumor metagenicity, 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 HER2-negative MBC and to define an anakinra-induced anti-IL-1 whole blood
transcriptional profile.

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.

- HER2-negative breast cancer. If HER2-, it is defined as follows:

1. FISH-negative (FISH ratio <2.0), or

2. IHC 0-1+, or

3. IHC 2+ AND FISH-negative (FISH ratio<2.0)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

- Adequate hematologic function, defined by:

1. Absolute neutrophil count (ANC) >1500/mm^3

2. Platelet count ≥100,000/mm^3

3. Hemoglobin >8 g/dL

- Adequate liver function, defined by:

1. AST and ALT ≤2.5 x the upper limit of normal (ULN) or ≤5 x ULN in presence of
liver metastases

2. 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

- Measurable or nonmeasurable disease by RECIST v1.1 criteria

- Life expectancy ≥24 weeks

- Adequate recovery from recent surgery

1. Major surgical procedure >28 days from study entry

2. 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 or untreated brain metastases or meningeal metastases are
ineligible. 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) patient has been off dexamethasone for >2 weeks; 2) no known
progression of brain metastasis.

- 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:

1. 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

2. uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN

3. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety - Adverse Events in participants

Outcome Description:

Patients will receive anakinra plus the physicians chemotherapy choice of nab paclitaxel, or capecitabine, or eribulin, or vinorelbine for metastatic breast cancer. Adverse events will be recorded throughout the trial, and regardless of the severity will be followed up by investigator until resolution is satisfactory. All adverse events and toxicities will be recorded and assessed for 30 days following the last dose of anakinra at a maximum of 6 months. Grading will be done using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Outcome Time Frame:

up to 7 months

Safety Issue:


Principal Investigator

Joyce O'Shaughnessy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System


United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

July 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Anakinra
  • Nab Paclitaxel
  • Capecitabine
  • Eribulin
  • Vinorelbin
  • Breast Neoplasms



Baylor University Medical CenterDallas, Texas  75246