Clinical trial · Observational
A Pilot Study Evaluating the Immunologic Status of Patients With HER2+ Breast Cancer
NCT00477139CI-TRIAL-00004674completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years of age * Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease. * HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions * Immunohistochemistry (IHC) 3+, or * FISH + (HER-2 gene signal to centromere 17 signal \>2) * No transfusion dependent patients and no transfusion within 30 days of leukopheresis * Documented labs within 7 days of donation consisting of: * WBC \> 4.0 K/ul \& \< 11.0 K/ul * platelet count \> 150,000/mm3 * hemoglobin \> 11.0 g/dl. * Hematocrit \> 33 % * Weight \> 110 lbs * No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable) * Patients must not have active or unresolved infection. * No cold or flu sympton at time of donation * No prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion) * All patients must give signed written informed consent. * ECOG Performance Score of 0 or 1. * Women of childbearing potential must have a negative serum or urine pregnancy test Exclusion Criteria: * The presence of another active malignancy * Pregnant, lactating, or nursing * Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)
References
Publications (0)
Data not yet available
No reference posted for this study.