Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02157051
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have:
* No evidence of disease (NED), or
* Stable bone only disease
* Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
* Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment
* Patients must be at least 28 days post systemic steroids prior to enrollment
* Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 1
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
* Estimated life expectancy of more than 6 months
* White blood cells (WBC) \>= 3000/mm\^3 (within 30 days of first vaccination)
* Lymphocyte count \>= 800/mm\^3 (within 30 days of first vaccination)
* Platelet count \>= 75,000/mm\^3 (within 30 days of first vaccination)
* Hemoglobin (Hgb) \>= 10 g/dl (within 30 days of first vaccination)
* Serum creatinine \<= 1.2 mg/dl or creatinine clearance \> 60 ml/min (within 30 days of first vaccination)
* Total bilirubin \<= 1.5 mg/dl (within 30 days of first vaccination)
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \<= 2 times upper limit of normal (ULN) (within 30 days of first vaccination)
* Blood glucose \< 1.5 ULN (within 30 days of first vaccination)
* All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study
Exclusion Criteria:
* Patients with any of the following cardiac conditions:
* Symptomatic restrictive cardiomyopathy
* Unstable angina within 4 months prior to enrollment
* New York Heart Association functional class III-IV heart failure on active treatment
* Symptomatic pericardial effusion
* Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
* Patients with any seizure disorder
* Patients with any contraindication to receiving rhuGM-CSF based products
* Patients with any clinically significant autoimmune disease uncontrolled with treatment
* Patients who are simultaneously enrolled in any other treatment study
* Patients who are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02157051
Study Brief:
Protocol Section:
NCT02157051