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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT00640861
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Clinical stage II or III disease
* No radiographic evidence of disease at the time of enrollment
* Has undergone surgery, adjuvant chemotherapy, and/or radiotherapy
* Completed "standard first-line therapy" only (including adjuvant therapy) for breast cancer within the past 3 months and currently with no evidence of disease
* Patients with stage I breast cancer with high-risk features are eligible provided 1 of the following criteria are met:
* HER2 over-expression or amplification
* Triple-negative (i.e., no expression of ER, PR, or over-expression of HER2 on routine immunohistochemical staining)
* .
* MUC1-positive breast cancer
* HLA-A2 positive
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-2
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 75,000/μL
* ANC ≥ 1,500/uL
* Creatinine ≤ 2 times upper limit of normal (ULN)
* AST ≤ 2 times ULN
* No uncontrolled infection
* No known HIV infection
* No other circumstances (e.g., concurrent use of systemic immunosuppressants or immunocompromising condition) that in the opinion of the physician would render the patient a poor candidate for this trial
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior invasive malignancies within the past 5 years (with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Fully recovered from acute, reversible effects of any prior breast cancer therapy
* No more than 3 years since prior surgery for primary breast cancer
* Concurrent anti-estrogen therapy is allowed
* No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)
* No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00640861
Study Brief:
Protocol Section:
NCT00640861