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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00376805
Eligibility Criteria:
Inclusion criteria:
* Diagnosis of metastatic breast cancer that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:
* Measureable metastatic disease per Response Evaluation Criteria In Solid Tumor (RECIST) - bone only not eligible.
* Disease progression while receiving prior therapy with a hormonal agent (if estrogen/progesterone receptor-positive) and/or trastuzumab (Herceptin®) (if HER2-neu positive)
* Brain metastases allowed provided they are stable for ≥ 3 months after prior treatment
* Related HLA-haploidentical natural killer cell donor available (by ≥ class I serologic typing)
* Male or female
* Performance status 50-100%
* Platelet count ≥ 80,000/mm³ (unsupported by transfusions)
* Hemoglobin ≥ 9 g/dL (unsupported by transfusions)
* Absolute neutrophil count ≥ 1,000/mm³ (unsupported by sargramostim \[GM-CSF\] or filgrastim \[G-CSF\])
* Creatinine ≤ 2.0 mg/dL
* Liver function tests \< 5 times normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* LVEF \> 40%\*
* Pulmonary function \> 50%\* (DLCO corrected AND FEV\_1)
* No active infection (i.e., afebrile, off antibiotics, and no uninvestigated radiologic lesions)
Exclusion Criteria:
* At least 3 days since prior prednisone or other immunosuppressive medications
* No other concurrent therapy for cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376805
Study Brief:
Protocol Section:
NCT00376805