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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00074269
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* Meets 1 of the following criteria:
* Chemotherapy-unresponsive disease defined as 1 of the following:
* Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession
* Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen
* Histologically confirmed tumor involvement on bone marrow biopsy
* Measurable or evaluable disease\* defined as the following:
* Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI
* Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only)
* Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: \*Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease
* Appropriate candidate for allogeneic stem cell transplantation
* No active CNS metastases
* Available HLA-identical sibling donor
* 6/6 antigen match
* Donor CD34 cells at least 2 times 10\^6/kg recipient weight
* Hormone receptor status:
* Estrogen receptor negative or positive
* Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Sex
* Female
Menopausal status
* Not specified
Performance status
* Karnofsky 70-100% OR
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 1,500/mm\^3
* Platelet count at least 30,000/mm\^3
Hepatic
* Bilirubin less than 3 times normal\*
* AST and ALT less than 3 times normal\* NOTE: \*Unless abnormality due to malignancy
Renal
* Creatinine no greater than 1.6 mg/dL
Cardiovascular
* LVEF greater than 40% by echocardiography or MUGA
* No myocardial infarction within the past 6 months
Pulmonary
* DLCO greater than 40% of predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No serious localized or systemic infection
* No hypersensitivity to E. coli-derived products
* No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix
* No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication
* No psychological condition or social situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* No concurrent glucocorticoids
Radiotherapy
* No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy
Surgery
* Not specified
Other
* No concurrent immunosuppressive medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00074269
Study Brief:
Protocol Section:
NCT00074269