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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT00317603
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed Stage IV breast cancer
* Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan
* Must have received at least one prior regimen of chemotherapy for metastatic disease
* Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently
* Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study
* ECOG performance status 0 or 1
* Estimated life expectancy of greater than or equal to 6 months
* 18 years of age or older
* Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
* Adequate recovery from drug-related toxicities from prior systemic therapies
* Adequate recovery from recent surgery and radiation therapy
* Greater than 6 months since bone marrow or peripheral blood stem cell transplant
Exclusion Criteria:
* Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days
* Uncontrolled active infection or illness
* Psychiatric illness/social situation that would limit study compliance
* Pregnant or nursing mothers
* Evidence of HIV infection
* Previous participation in an adenovirus-based trial
* Concurrent invasive malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00317603
Study Brief:
Protocol Section:
NCT00317603