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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT00382018
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Clinical evidence of metastatic disease (stage IV disease)
* Newly metastatic disease OR progressive metastatic disease while on hormonal therapy
* Meets 1 of the following criteria:
* Measurable disease
* Bone-only disease\* NOTE: \*Patients with nonmeasurable disease that does not include bone are not eligible
* HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay
* HER-2 positivity is defined as IHC 3+ or FISH+
* If IHC is indeterminate (2+), FISH must be performed to classify disease
* Planning to undergo first-line chemotherapy for metastatic disease
* Patients with brain metastases must have stable disease for \> 90 days after completion of prior radiotherapy to the brain
* No leptomeningeal disease
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* Zubrod performance status 0-2
* Not pregnant or nursing
* Negative pregnancy test
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed
* Any number of exogenous hormonal therapies for metastatic disease and/or as adjuvant therapy allowed
* At least 1 year since prior adjuvant chemotherapy
* At least 2 weeks since prior minor surgery and recovered
* At least 4 weeks since prior major surgery and recovered
* No prior chemotherapy for metastatic disease
* Concurrent hormonal therapy and/or bisphosphonate therapy allowed
* Concurrent trastuzumab and/or bevacizumab allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00382018
Study Brief:
Protocol Section:
NCT00382018