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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT01434303
Eligibility Criteria:
Inclusion Criteria:
* Patients have histological confirmation of invasive breast carcinoma
* Patients have locally recurrent or distant relapsed metastatic disease
* Patients have positive HER2 expression by immunohistochemistry (IHC) (3+) or fluorescence in situ hybridization (FISH) testing (\> 2.0 ratio)
* Patients are able to swallow and retain oral medication (i.e., no uncontrolled vomiting, inability to swallow, or diagnosis of chronic malabsorption)
* Patients have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients must have received prior trastuzumab for \> 2 month period before disease recurrence or recurrence or progression while on trastuzumab-based therapy
* Patients have ability and willingness to sign written informed consent
* Female patients of childbearing potential (a female not free from menses \> 2 years or not surgically sterilized) must be willing to use an adequate barrier method of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study; male patients who are able to father children must use an adequate barrier method of contraception
* Female patients of childbearing potential must have negative serum pregnancy test within 14 days of starting protocol therapy
* Patients with brain metastasis have no signs of progressive disease 4 months after the completion of brain metastasis treatment (radiation therapy, surgery, etc.) do not require anticonvulsants or corticosteroids, and have been off such drugs for at least 7 days
* Both men and women and members of all races and ethnic groups are eligible for this trial
Exclusion Criteria:
* Patients are receiving concurrent anti-cancer therapy (chemotherapy, immunotherapy, biological therapy and hormonal therapy) while taking study medication
* Serum bilirubin \>= 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>= 3 x ULN (with or without liver metastasis \[mets\])
* Absolute neutrophil count (ANC) \< 1.5
* Hemoglobin =\< 9
* Platelet =\< 140,000
* Patients have an active infection and require intravenous (IV) or oral antibiotics
* Cardiac arrhythmia requiring maintenance medication
* History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
* Patients have a concurrent disease or condition that would make them inappropriate for study participation, or any serious medical disorder that would interfere with patients' safety
* Serum creatinine \> 2.0 mg/dL
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01434303
Study Brief:
Protocol Section:
NCT01434303