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:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01355393
Eligibility Criteria:
Inclusion Criteria:
* Patients with stage II, or III HER2+ breast cancer who have completed definitive standard treatment and are in complete remission - or -
* Patients with stage IV HER2+ breast cancer treated to:
* No evidence of disease, or
* Stable bone only disease after definitive therapy
* Patients must have demonstrated HER2 positive disease, by one of the following methods:
* Immunohistochemical (IHC) staining of 1+, 2+ or 3+ for the HER2 protein, or
* Amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
* Patients must be at least 14 days post cytotoxic chemotherapy prior to enrollment
* Patients must be at least 14 days post systemic steroids prior to enrollment
* Patients on bisphosphonates or continued hormone therapy are eligible
* Men and women of reproductive ability must agree to contraceptive use during the entire study period
* Patients must have Zubrod Performance Status Score of =\< 2
* 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
* White blood cell count (WBC) \>= 3000/mm\^3
* Hemoglobin (Hgb) \>= 10 mg/dl
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
* Total bilirubin =\< 1.5 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) =\< 2.5 times the upper limit of normal
* Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fractions (EF) on multi gated acquisition scan (MUGA) scan or echocardiogram performed within the last 3 months of eligibility sign off
Exclusion Criteria:
* Restrictive cardiomyopathy
* Unstable angina within 6 months prior to enrollment
* New York Heart Association functional class III-IV heart failure
* Symptomatic pericardial effusion
* Patients with any contraindication to receiving rhuGM-CSF based products
* Patients with any clinically significant autoimmune disease requiring active treatment
* Patients receiving any concurrent immunomodulators within 30 days of eligibility sign-off
* Patients who are pregnant or breast-feeding
* Patients who are simultaneously enrolled in any other treatment study
* Patients who have received a previous HER2 breast cancer vaccine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01355393
Study Brief:
Protocol Section:
NCT01355393