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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT00436566
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of early-stage breast cancer
* HER2 positive by immunohistochemistry (IHC) (3+) or fluorescent in situ hybridization (FISH)
* Ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification
* No locally advanced tumors (i.e., T4) at diagnosis, including the following:
* Tumors fixed to chest wall
* Peau d'orange
* Skin ulcerations or nodules
* Clinical inflammatory changes (e.g., diffuse brawny cutaneous induration with an erysipeloid edge)
* Has undergone mastectomy or lumpectomy with axillary node or sentinel node dissection within the past 84 days
* Patients who have undergone a mastectomy must meet the following criteria:
* No evidence of gross or microscopic tumor (i.e., invasive DCIS) at the surgical resection margins noted in final surgery or pathology reports
* Patients with close margins are eligible
* Radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy
* Patients who have undergone a lumpectomy with axillary node or sentinel node dissection must meet the following criteria:
* No evidence of invasive cancer or DCIS at the surgical resection margins
* No gross residual adenopathy
* Planning to undergo radiation therapy to the breast with or without regional lymphatics after completion of chemotherapy
* No active hepatic or biliary disease
* Patients with liver metastases, stable chronic liver disease, Gilbert's syndrome, or asymptomatic gallstones are eligible
* Hormone receptor status:
* Estrogen receptor and progesterone receptor status known
PATIENT CHARACTERISTICS:
* Male or female
* Menopausal status not specified
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 10.0 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* LVEF ≥ 50% by MUGA scan or echocardiogram
* Able to complete questionnaire(s) by themselves or with assistance
* Able and willing to provide blood and tissue samples
* No known sensitivity to benzyl alcohol
* No sensory neuropathy ≥ grade 2
* No active cardiac disease, including any of the following:
* Myocardial infarction within the past 6 months
* Prior or concurrent congestive heart failure
* Prior or concurrent arrhythmia or cardiac valvular disease requiring medications or that is clinically significant
* Uncontrolled hypertension, defined as diastolic blood pressure (BP) \>100 mm Hg or systolic BP \> 200 mm Hg on 2 separate occasions ≥ 14 days apart
* Clinically significant pericardial effusion
* Prior or concurrent uncontrolled or symptomatic angina
* Other cardiac condition that, in the opinion of the treating physician, would put the patient at hazardous risk
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition as lapatinib ditosylate
* No uncontrolled intercurrent illness including, but not limited to, the following:
* Ongoing or active infection
* Psychiatric illness or social situations that would preclude study compliance
* Able to swallow and retain oral medication
* No history of gastrointestinal (GI) disease resulting in an inability to take oral medication, including any of the following:
* Malabsorption syndrome
* Requirement for IV alimentation
* Prior surgical procedures affecting absorption
* Uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for breast cancer
* No primary breast radiation therapy as part of breast-conserving treatment
* No prior anthracycline or taxane therapy for any malignancy
* No prior epidermal growth factor receptor-targeting therapies (e.g., gefitinib, cetuximab, erlotinib hydrochloride, rituximab, trastuzumab \[Herceptin®\], lapatinib ditosylate, panitumumab, or nimotuzumab)
* At least 14 days since prior and no concurrent CYP3A4 inducers, including the following:
* Rifamycin-class antibiotics (e.g., rifampin, rifabutin, or rifapentine)
* Anticonvulsants (e.g., phenytoin, carbamazepine, or barbiturates \[e.g., phenobarbital\])
* Antiretrovirals (e.g., efavirenz or nevirapine)
* Glucocorticoids (e.g., oral cortisone, hydrocortisone, prednisone, methylprednisolone, or dexamethasone)
* Daily oral dexamethasone ≤ 1.5 mg (or equivalent) allowed
* Modafinil
* Hypericum perforatum (St. John's wort)
* At least 7 days since prior and no concurrent CYP3A4 inhibitors, including the following:
* Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)
* Antifungals (e.g., itraconazole, ketoconazole, fluconazole \[\> 150 mg daily\], or voriconazole)
* Antiretrovirals and protease inhibitors (e.g., delaviridine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)
* Calcium channel blockers (e.g., verapamil or diltiazem)
* Antidepressants (e.g., nefazodone or fluvoxamine)
* Gastrointestinal agents (e.g., cimetidine or aprepitant)
* Grapefruit and grapefruit juice
* At least 6 months since prior and no concurrent amiodarone
* No herbal or alternative medicines or supplements ≥ 14 days before, during, and for 30 days after completion of study treatment
* No concurrent hormonal agents (e.g., birth control pills, ovarian hormonal replacement therapy, or raloxifene)
* Adjuvant hormonal agents (e.g., tamoxifen, aromatase inhibitors) allowed after completion of chemotherapy as part of treatment for breast cancer
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent digitalis or beta-blockers for congestive heart failure
* No concurrent arrhythmia or angina pectoris medication
* No other concurrent investigational agents or anticancer therapies, including cytotoxic agents or immunotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00436566
Study Brief:
Protocol Section:
NCT00436566