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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00303992
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic breast carcinoma
* Received 1-3 prior chemotherapy regimens for metastatic disease
* Documented progressive disease
* Repeated courses of the same chemotherapy agent alone or in combination are considered a single regimen
* Prior trastuzumab (Herceptin®) alone or with chemotherapy allowed
* Other biologic agents are not considered a chemotherapy regimen
* Measurable disease
* Patients with bone-only disease who are evaluable by tumor markers (e.g., CA15-3, CEA, or CA27.29) are eligible
* Patients must have prior evidence of correlation of disease activity with changes in tumor marker level
* Confirmation of HER2/neu status by a positive test for gene amplification by fluorescence in situ hybridization or 3+ by immunohistochemistry
* Brain metastases allowed if the following criteria are met:
* Brain metastases were previously treated and are currently stable as documented by head CT scan with contrast or MRI within 4 weeks of study entry
* Patients with existing brain metastases should have stability documented by prior imaging ≥ 8 weeks before the baseline scan
* Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status ≤ 2
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Life expectancy ≥ 12 weeks
* No history of congestive heart failure
* Documented ejection fraction ≥ 45% by MUGA scan or echocardiogram within 1 month of study entry
* Total bilirubin \< 3 times upper limit of normal (ULN)
* AST \< 3 times ULN (5 times ULN if due to liver involvement)
* Creatinine \< 1.5 times ULN
* No history of serious adverse events related to trastuzumab
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe, concurrent illness that would prevent compliance with study protocol
* No chronic severe diarrheal illness
* No history of Gilbert's disease or known deficiency in glucuronidation
* No recent or current history of alcoholism or acute viral hepatitis
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No chemotherapy or hormonal therapy within the past 2 weeks
* Prior or concurrent bisphosphonates allowed
* No prior irinotecan (other camptothecins allowed)
* No concurrent radiotherapy
* No ongoing treatment with any other investigational agent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
120 Years
Study:
NCT00303992
Study Brief:
Protocol Section:
NCT00303992