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 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 1:02 AM
NCT ID:
NCT00182793
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
* Stage IIIB or IIIC disease, meeting both of the following criteria:
* Must have received prior neoadjuvant or adjuvant therapy
* Must have undergone lumpectomy or mastectomy
* Stage IV disease, meeting all of the following criteria:
* Only 1-3 organ sites with disease involvement after induction chemotherapy
* Achieved at least a partial response after induction chemotherapy
* No more than 3 lesions in the organ sites combined
* Inflammatory breast cancer allowed
* Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 65 and under
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Karnofsky 80-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT or SGPT ≤ 2 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.2 mg/dL
* Creatinine clearance ≥ 70 mL/min
Cardiovascular
* LVEF ≥ 55% by MUGA or echocardiogram
Pulmonary
* FEV\_1 ≥ 60% of predicted
* DLCO ≥ 60% of the lower limit of predicted value
* Oxygen saturation \> 92% on room air
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No autoimmune disorders
* No immunosuppressive condition
* No other malignancy within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy except trastuzumab (Herceptin®)
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy to adjacent or involved sites of disease that would preclude study radiotherapy
Surgery
* See Disease Characteristics
Other
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
65 Years
Study:
NCT00182793
Study Brief:
Protocol Section:
NCT00182793