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 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT00003205
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Unequivocal diagnosis of metastatic breast cancer
* Bidimensionally measurable disease
* No uncontrolled CNS metastases
* No disease that is evaluable only, including blastic bone disease, malignant ascites, and malignant pleural effusion
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Menopausal status:
* Not specified
Performance status:
* SWOG 0-2 OR
* Karnofsky 60-100%
Life expectancy:
* At least 18 weeks
Hematopoietic:
* Platelet count at least 50,000/mm\^3
* PT and PTT within normal limits
* Neutrophil count at least 2,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.2 mg/dL
* Transaminases no greater than 3 times normal
Renal:
* Creatinine no greater than 1.6 mg/dL OR
* Creatinine clearance at least 70 mL/min
Other:
* No active infections requiring antibiotics
* No viral hepatitis allowed
* Seronegative for hepatitis B or C
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 2 months following study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* 2 prior chemotherapy regimens for metastatic disease allowed as adjuvant therapy or for advanced disease (may include high dose chemotherapy with stem cell support)
* At least 4 weeks since prior chemotherapy
* At least 6 weeks since prior nitrosourea or mitomycin therapy
* No other concurrent chemotherapy
Endocrine therapy:
* 2 prior hormonal therapy regimens for metastatic disease as adjuvant therapy or for advanced diseases allowed
* At least 2 weeks since prior hormonal therapy (at least 4 weeks in case of disease progression while receiving hormonal therapy after initial response)
* No concurrent hormonal therapy except oral contraceptives
* No concurrent use of steroids except for management of severe or life- threatening toxic effects arising from bryostatin 1
Radiotherapy:
* At least 2 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No concurrent use of drugs known to interfere with platelet function, such as aspirin or NSAIDs (including ibuprofen)
* No concurrent use of anticoagulants
* At least 2 weeks since prior use of aspirin
* At least 2 days since prior use of NSAIDS
* Concurrent use of acetaminophen to control pain is allowed
* If acetaminophen inadequate for pain control, concurrent use of oral narcotics such as codeine or oxycodone is allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003205
Study Brief:
Protocol Section:
NCT00003205