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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00068757
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Stage IIIB, IIIC, or IV
* HER2/neu overexpression
* 3+ by immunohistochemistry
* 2+ allowed if positive fluorescent in situ hybridization
* Disease meets the following treatment criteria:
* Paclitaxel/trastuzumab (Herceptin®) may be appropriate therapy
* Anthracycline therapy is not a suitable approach
* No clinical signs of CNS involvement
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* ECOG 0-2 OR
* WHO 0-2
Life expectancy
* Not specified
Hematopoietic
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL (6.2 mmol/L)
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 2.5 times ULN (5 times ULN if liver metastases are present)
* AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine clearance at least 40 mL/min
Cardiovascular
* Cardiac ejection fraction normal by MUGA
* QTc interval no greater than 440 msec
* No cardiac dysfunction
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 3 months after study participation
* No concurrent severe/unstable systemic disease
* No infection
* No circumstances that would preclude study participation (e.g., alcoholism or substance abuse)
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 1 year since prior trastuzumab
* No concurrent prophylactic growth factors
Chemotherapy
* More than 1 year since prior paclitaxel
* More than 4 weeks since other prior chemotherapy
Endocrine therapy
* More than 1 day since prior hormonal therapy
* More than 2 days since prior high-dose chronic steroids
* More than 2 days since prior ethinyl estradiol
* No concurrent high-dose chronic steroids
* No concurrent ethinyl estradiol
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 2 days since prior administration of and no concurrent CYP3A4 inducers or inhibitors, including any of the following:
* Gestodene
* Itraconazole
* Ketoconazole
* Cimetidine
* Erythromycin
* Carbamazepine
* Phenobarbital
* Phenytoin
* Rifampin
* Sulfinpyrazone
* No concurrent grapefruit juice
* No other concurrent anticancer agents
* No other concurrent investigational therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00068757
Study Brief:
Protocol Section:
NCT00068757