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 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT00343759
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically-confirmed by either core or fine needle biopsy primary invasive carcinoma of the breast;
* AJCC T2-T3 disease (\>2.0 cm without chest wall or skin invasion) by at least one imaging modality (either mammogram, ultrasound, or MRI) - entry criteria is based on radiologic staging and not final pathologic staging;
* ECOG performance status 0-1 (Karnofsky ≥ 70%
* Any lymph node status, hormone receptor status, and level of erbB2 expression
* No prior chemotherapy, hormonal therapy or radiation therapy to the affected breast for current or previous malignancy;
* Cardiac ejection fraction \>50% or within the institutional range of normal;
* Patients must have normal organ and marrow function defined as: Leukocyte count \>3000/uL; Absolute neutrophil count (ANC) ≥ 1,500/mm3, platelets \> 100,000/mm3, and hemoglobin ≥ 8 gm/dl; Serum creatinine ≤ 1.5 times ULN, or 24-hour creatinine clearance ≥ 75 cc/min; Serum bilirubin ≤ 1.5 times ULN; SGOT ≤ 2.5 times ULN; alkaline phosphatase ≤ 2.5 ULN times ULN.
* The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and the willingness to sign written informed consent document.
Exclusion Criteria:
* AJCC T1, T4, or stage 4 disease;
* Patients may not have undergone incisional or excisional biopsy of their tumor;
* Patients may not be receiving any other investigational agents;
* Absolute contraindication to MRI imaging (cardiac pacemaker or any non-removable metallic foreign object in the body);
* On chronic therapy with any known inducer or inhibitor of CYP3A4
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or lactating women are excluded from this study because lapatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00343759
Study Brief:
Protocol Section:
NCT00343759