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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT00450892
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer meeting the following criteria:
* Phase I
* Locally advanced or inflammatory disease, or specified subgroup of large operable disease for whom neoadjuvant chemotherapy is appropriate, defined as any 1 of the following:
* Clinical stage T4a-d, any N (inflammatory breast carcinoma: tumor mass, breast enlargement, oedema and warmth of the skin are often present but not mandatory for the diagnosis)
* Any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
* cT3cN0,1 any estrogen receptor (ER)
* cT2cN1 any ER
* cT2cN0 ER negative
* Presence of bilateral breast cancer is allowed
* No bone, liver, or other extensive metastases
* Minimal lung, skin, or nodal metastases may be allowed at the discretion of the investigator (phase I only)
* Phase II
* Locally advanced or inflammatory breast cancer, defined as any 1 of the following:
* Clinical T4a-d, any N (inflammatory breast carcinoma: tumor mass, breast enlargement, oedema and warmth of the skin are often present but not mandatory for the diagnosis)
* Any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
* And M0
* Bilateral breast cancer is allowed provided only 1 side is HER2-positive
* Any large resectable T2 or T3 breast cancers, M0
* HER2-positive disease by immunohistochemistry, fluorescent in situ hybridization, and/or chromogenic in situ hybridization
* No CNS involvement
* Two frozen trucuts for every core biopsy indicated by the translational research study
* Hormone receptor status:
* Estrogen receptor- and/or progesterone receptor-positive or negative tumor
PATIENT CHARACTERISTICS:
* Female
* WHO performance status 0-2
* Hemoglobin \> 10.0 g/dL
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Bilirubin \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 3 times ULN
* Creatinine \< 1.5 times ULN
* No other malignancies within the past 3 years except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix (phase II)
* LVEF normal by MUGA or ECHO
* ECG normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 2 weeks prior to, during, and for 1 month after completion of study treatment
* No current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease not requiring therapy as per investigator assessment)
* No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
* History of documented congestive heart failure
* High-risk uncontrolled arrhythmias
* Angina pectoris requiring antianginal medication
* Clinically significant valvular heart disease
* Evidence of transmural infarction on ECG
* Poorly controlled hypertension, defined as systolic blood pressure (BP) \> 180 mm Hg or diastolic BP \> 100 mm Hg
* Able to swallow and retain oral medication
* Accessible for repeat dosing and follow up
* No concurrent grapefruit juice
* No active or uncontrolled infection
* No other serious illness
* No malabsorption syndrome
* No other medical condition (i.e., history of chronic alcohol abuse, hepatitis, HIV, and/or cirrhosis)
* No psychological, familial, sociological, or geographical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
* No prior therapy for any cancer, including chemotherapy, radiotherapy, or hormonal therapy for breast cancer (phase I)
* No prior epidermal growth factor receptor- or HER2-targeted therapy or antibody therapy (phase I)
* More than 10 days since prior and no concurrent CYP3A4 inducers or inhibitors
* More than 14 days since prior and no concurrent herbal infusions or dietary supplements
* No antacids 1 hour before or after lapatinib ditosylate administration
* No other concurrent investigational therapy or anticancer therapy
* No concurrent prophylactic antibiotics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00450892
Study Brief:
Protocol Section:
NCT00450892