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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT00079118
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* Previously treated with chemotherapy in the adjuvant setting and/or for metastatic disease
* At least one unidimensionally measurable lesion
* At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan
* Superficial clinical lesions (e.g., skin nodules or palpable lymph nodes) are allowed
* Lesions on chest x-ray are allowed provided they are clearly defined and surrounded by aerated lung
* The following are not considered measurable:
* Bone lesions
* Ascites
* Leptomeningeal disease
* Pleural/pericardial effusion
* Inflammatory breast disease
* Lymphangitis cutis/pulmonis
* Cystic lesions
* No known CNS metastases unless controlled by prior surgery and/or radiotherapy
* Hormone receptor status:
* Estrogen receptor (ER) and/or progesterone receptor (PR) status known
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ upper limit of normal (ULN)
* Meets 1 of the following criteria:
* AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
* Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN
* AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No myocardial infarction within the past 180 days
* No congestive heart failure
* No unstable angina
* No clinically significant pericardial effusion or arrhythmias
Other
* No active, unresolved infection
* No prior severe hypersensitivity reaction to docetaxel, irinotecan, or any drug formulated with polysorbate 80
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No grade 1 or greater sensory or motor neuropathy
* No other concurrent severe condition that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior trastuzumab (Herceptin®) required for HER-2-positive patients (unless contraindicated)
Chemotherapy
* See Disease Characteristics
* More than 14 days since prior chemotherapy
* No more than 2 prior chemotherapy regimens for metastatic disease
* No prior irinotecan or docetaxel for metastatic disease
* Docetaxel as adjuvant therapy allowed
* No other concurrent chemotherapy
Endocrine therapy
* Prior hormonal therapy required for patients with ER- and/or PR-positive tumors (unless contraindicated)
Radiotherapy
* See Disease Characteristics
* At least 30 days since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* At least 3 weeks since prior major surgery and recovered
Other
* More than 7 days since prior parenteral antibiotic therapy
* No other concurrent experimental drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00079118
Study Brief:
Protocol Section:
NCT00079118