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 @ 6:57 PM
Ignite Modification Date:
2025-12-24 @ 6:57 PM
NCT ID:
NCT00086957
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Metastatic disease
* HER-2/neu overexpression (3+ by immunohistochemistry OR 2+ by fluorescence in situ hybridization)
* Measurable or evaluable disease
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST and ALT \< 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of liver metastases)
* Bilirubin \< 1.5 times ULN
* No unstable or uncompensated hepatic disease
Renal
* Creatinine \< 1.6 mg/dL
* No unstable or uncompensated renal disease
Cardiovascular
* LVEF \> 45% by echocardiogram or MUGA
* No prior New York Heart Association class I-IV heart disease
* No prolonged PR interval or atrioventricular block on ECG
* No unstable or uncompensated cardiac disease
Pulmonary
* No unstable or uncompensated respiratory disease
* No clinically active interstitial lung disease
* Patients who are asymptomatic and have chronic stable radiographic changes are allowed
Immunologic
* No autoimmune disorders
* No conditions of immunosuppression
* No severe hypersensitivity to taxane or gefitinib or any of its excipients
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other prior or concurrent malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
* No other severe or uncontrolled systemic disease
* No other acute or chronic medical condition that would preclude study participation
* No other significant clinical disorder or laboratory finding that would preclude study participation
* No psychiatric illness that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior adjuvant trastuzumab (Herceptin®) allowed if \> 6 months elapsed before disease recurrence
* No prior trastuzumab for metastatic breast cancer
* No prior monoclonal antibodies directed at the epidermal growth factor receptor (EGFR)
Chemotherapy
* Prior adjuvant chemotherapy (or as first-line therapy for metastatic breast cancer) allowed
* Prior adjuvant taxane allowed if completed \> 6 months before diagnosis of metastatic breast cancer
* No prior docetaxel for metastatic breast cancer
Endocrine therapy
* Prior adjuvant hormonal therapy (or as first-line therapy for metastatic breast cancer) allowed
* No concurrent hormonal therapy
* Concurrent steroids allowed provided dose is stable
Radiotherapy
* Not specified
Surgery
* Fully recovered from prior oncologic or other major surgery
* No concurrent surgery within 7 days of gefitinib administration
Other
* Recovered from prior anticancer therapy (alopecia allowed)
* More than 30 days since prior non-approved drug or investigational agent
* No other prior EGFR-directed therapy (i.e., tyrosine kinase inhibitors)
* No concurrent use of any of the following medications:
* Phenytoin
* Carbamazepine
* Barbiturates
* Rifampin
* Hypericum perforatum (St. John's wort)
* No other concurrent anticancer therapy
* No concurrent cardioprotective drugs
* No concurrent oral retinoids
* Concurrent participation in the City of Hope indium-labeled trastuzumab imaging study allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00086957
Study Brief:
Protocol Section:
NCT00086957