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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT00074100
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Metastatic (stage IV) disease
* Relapsed after 1 of the following prior therapy regimens\*:
* Adjuvant therapy containing an anthracycline and a taxane
* Adjuvant anthracycline therapy followed by first-line metastatic treatment containing a taxane NOTE: \*No relapse within 12 months of initiation of prior therapy
* Measurable disease by CT scan or MRI
* No ascites, pleural effusions, or osteoblastic bone metastases as the only site of measurable disease
* Refractory to hormonal anticancer therapy completed more than 4 weeks before study therapy
* HER2/neu positive allowed provided patient received prior trastuzumab (Herceptin®)
* MUGA or echocardiogram normal while on trastuzumab
* No known history of or current brain or leptomeningeal metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Over 18
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* WBC at least 3,000/mm\^3
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
* No clinically significant abnormal hematological parameters
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
* AST or ALT no greater than 2.5 times ULN (5 times ULN in case of liver metastases)
Renal
* Creatinine no greater than 1.5 times ULN
Cardiovascular
* See Disease Characteristics
* No myocardial infarction within the past 3 months
* No unstable angina pectoris
* No New York Heart Association class III or IV heart disease
* No uncontrolled arrhythmia
* No cardiac insufficiency
* No uncontrolled hypertension
* LVEF at least 50% OR at least lower limit of normal
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 4 weeks before, during, and for at least 4 weeks after study participation
* No preexisting neuropathy (motor or sensory) greater than grade 2
* No clinically significant abnormal biochemical parameters
* No clinically significant active infection
* No other prior malignancy except cured nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
* No other serious illness or medical condition
* No psychological illness or condition that would preclude study participation
* No other known condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* More than 3 months since prior trastuzumab
* More than 2 weeks since prior growth factor therapy (i.e., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
* No concurrent systemic anticancer immune modulators
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* See Disease Characteristics
* More than 4 weeks since prior hormonal therapy
* No concurrent anticancer hormonal therapy
* No concurrent chronic systemic steroids
* Concurrent topical or inhaled steroids for dermatological or allergy/asthma conditions allowed provided therapy was initiated prior to study enrollment
* Concurrent hormone replacement therapy allowed provided therapy was initiated prior to study enrollment
Radiotherapy
* More than 30 days since prior radiotherapy
* No concurrent radiotherapy directed at target lesions
Surgery
* At least 4 weeks since prior major surgery and recovered
Other
* More than 30 days since prior investigational new drug
* More than 2 weeks since prior blood transfusion
* No other concurrent systemic anticancer agents, including immunosuppressive agents
* No other concurrent investigational agents
* Concurrent bisphosphonates allowed provided therapy was initiated prior to study enrollment
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00074100
Study Brief:
Protocol Section:
NCT00074100