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 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT00096057
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Locally advanced or metastatic disease
* No inflammatory breast cancer
* Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria)
* Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy
* Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®)
* No known CNS metastases
* No metastases accessible to complete surgical resection
* Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available
* Appropriate tumor block also acceptable
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* WHO 0-1
Life expectancy
* At least 4 months
Hematopoietic
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1,500/mm\^3
* WBC ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 1.5 mg/dL
* ALT or AST ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in patients with liver metastases) OR
* Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN in patients with liver metastases)
* Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases
Renal
* Creatinine ≤ 1.5 times ULN OR
* Creatinine clearance \> 60 mL/min
* Uric acid \< 1.25 times ULN (for patients with hyperuricemia only)
* Calcium (corrected for serum albumin) \< 11.5 mg/dL (for patients with hypercalcemia only)
Cardiovascular
* LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia
* No other uncontrolled illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* Prior biological therapy allowed
* More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery
* No other concurrent antitumor immunotherapy
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior cytotoxic chemotherapy
* No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy
* No concurrent antitumor chemotherapy
Endocrine therapy
* Prior hormonal therapy allowed
* No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions
* No concurrent antitumor hormonal therapy
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy (except for palliative radiotherapy)
* No concurrent antitumor radiotherapy, except for palliation to non-study lesions
* Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period
Surgery
* More than 4 weeks since prior major surgery
Other
* More than 30 days since prior investigational agents
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00096057
Study Brief:
Protocol Section:
NCT00096057