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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00057993
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage IV or locally advanced disease
* Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks
* HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry
* Measurable disease defined by 1 of the following criteria:
* At least 1 dimension at least 1 cm by CT scan or other imaging scan
* At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions)
* Palpable lesion with both diameters at least 1 cm with caliper OR
* Evaluable disease defined by 1 of the following criteria:
* Positive bone scan
* Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm
* Bone scan and CA 27.29 if bone scan only evaluable disease
* Hormone receptor status:
* Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Postmenopausal by 1 of the following criteria:
* 60 years of age and over
* 45 years of age and over with amenorrhea more than 12 months and an intact uterus
* Follicle-stimulating hormone levels within postmenopausal range
* Undergone bilateral oophorectomy
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin less than 1.5 times upper limit of normal
Renal
* Creatinine less than 2 mg/dL
Cardiovascular
* Ejection fraction greater than 50%
Other
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior trastuzumab (Herceptin)
Chemotherapy
* Prior chemotherapy allowed
Endocrine therapy
* No prior exemestane
* No other prior hormonal agent (except tamoxifen)
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00057993
Study Brief:
Protocol Section:
NCT00057993