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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT00082667
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR mammogram highly suspicious for DCIS
* No invasive disease
* Not completely excised
* Epidermal growth factor receptor (EGFR) positive (\> 10% of cells stained)
* Planned lumpectomy or mastectomy within the next 2-4 weeks
* Hormone receptor status:
* Estrogen receptor status known
PATIENT CHARACTERISTICS:
Age
* 35 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin \< 1.5 mg/dL
* SGOT ≤ 2 times upper limit of normal (ULN)
* SGPT \< 1.5 times ULN
* PT and PTT ≤ 1.5 times ULN
* INR ≤ 1.5 times ULN
Renal
* Creatinine \< 1.5 mg/dL
Cardiovascular
* No New York Heart Association class I-IV heart disease
Pulmonary
* No acute asthma
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Random blood sugar \< 2.5 times ULN
* No known hypersensitivity to study drug or its excipients
* No nonhealing wound or fracture
* No active infection
* No other malignancy within the past 5 years except basal cell carcinoma, breast carcinoma, or carcinoma in situ of the cervix
* No psychosis or severe depression
* No other concurrent uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior trastuzumab (Herceptin®)
Chemotherapy
* At least 1 year since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* At least 1 year since prior aromatase inhibitors
* At least 1 year since prior antiestrogens or luteinizing hormone-releasing hormone agonists or antagonists
* No concurrent glucocorticoids
* Concurrent oral contraceptives allowed
* Concurrent hormone replacement therapy allowed
Radiotherapy
* At least 1 year since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior oncologic or other major surgery
* No prior organ allograft
Other
* Recovered from all prior therapy (except alopecia)
* More than 30 days since prior non-approved or investigational drugs
* No prior definitive local therapy
* No prior immunosuppressive therapy
* No prior gefitinib
* No other prior EGFR inhibitors
* No other concurrent cytotoxic drugs
* No concurrent warfarin for anticoagulation
* No concurrent CYP3A4 inducers, including any of the following:
* Phenytoin
* Carbamazepine
* Barbiturates
* Rifampin
* Phenobarbital
* Hypericum perforatum (St. John's wort)
* Ethosuximide
* Griseofulvin
* Nafcillin
* Nelfinavir
* Nevirapine
* Oxcarbazepine
* Phenylbutazone
* Primidone
* Rifabutin
* Rofecoxib
* Sulfamethazine
* Sulfinpyrazone
* Troglitazone
* No concurrent antiretroviral treatment for HIV-positive patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT00082667
Study Brief:
Protocol Section:
NCT00082667