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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT00544804
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Advanced or metastatic disease
* No effective curative therapy available
* Bone-only disease allowed
* Tumor HER2 overexpression
* HER2 3+ expression by immunohistochemistry OR \> 2-fold (HER2 2+) gene amplification by fluorescence in situ hybridization
* Evaluable disease
* Measurable disease is not required
* No progressive brain metastases
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Female
* Menopausal status not specified
* Absolute neutrophil count ≥ 1,000 cells/mm\^3
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 75,000 cells/mm\^3
* Total bilirubin normal
* AST and ALT ≤ 3 x upper limits of normal (ULN) (≤ 5 x ULN with liver metastases)
* Creatinine normal OR creatinine clearance ≥ 40 mL/min
* INR ≤ 1.5
* Potassium normal
* Magnesium normal
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception prior to and during study therapy
* Cardiac ejection fraction ≥ 50%
* Consents to 2 tumor fine needle aspiration biopsies for biomarker analysis
* Lung-only disease or sites otherwise deemed high-risk for biopsy, the requirement for biopsy will be waived
Exclusion criteria:
* History of significant cardiac disease including any of the following:
* Congestive heart failure
* Symptomatic cardiac arrhythmias
* Unstable angina
* Uncontrolled prior lapatinib ditosylate therapy toxicity ≥ grade 2
* Allergic reactions to IV contrast dye despite standard prophylaxis
* History of malabsorption syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism, or excretion of study drug
* Conditions that would impair the patient's ability to swallow and retain oral medication
* Concurrent disease or condition that would make the patient inappropriate for study participation or would interfere with the patient's safety
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
PRIOR CONCURRENT THERAPY:
* Prior lapatinib ditosylate or trastuzumab allowed
* At least 4 weeks since prior and no concurrent chemotherapy or investigational anticancer agents
* At least 2 weeks since prior and no concurrent hormonal therapy
* At least 2 weeks since prior and no concurrent lapatinib ditosylate prohibited medications, including CYP3A4 inhibitors or inducers, all herbal supplements, and gastric pH modifiers
* More than 4 weeks since prior radiotherapy
* No aspirin or plavix therapy within 7 days prior to tumor biopsy
* No concurrent coumadin
* Low molecular weight heparin allowed provided it can be held at least 24 hours prior to tumor biopsy
* Concurrent gonadal suppression agents (i.e., Zoladex or Lupron) or palliative bisphosphonates (i.e., Zometa) allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00544804
Study Brief:
Protocol Section:
NCT00544804