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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT01868503
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically or cytologically confirmed locally advanced breast cancer that is refractory to chemotherapy or other therapeutic agents or with a history of breast cancer with new evidence of a local recurrence (defined as a chest wall or breast recurrence and/or nodal recurrence); the diagnosis will be made based on clinical and pathologic features
* Patients must be \>18 years of age.
* Karnofsky Performance Status (KPS) score \> 70
* Patts must have normal organ function as defined below:
* total bilirubin \< 1.5 x institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) \< 2.5 x institutional upper limit of normal
* creatinine \< 1.5 x institutional upper limit of normal
* Patients must have left-ventricular ejection fraction \> 50% at baseline.
Exclusion Criteria:
* Patients who have contraindications to radiotherapy, such as scleroderma, dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus (SLE)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or psychiatric illness/social situations that would limit compliance with study requirements
* Women who are pregnant or lactating, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01868503
Study Brief:
Protocol Section:
NCT01868503