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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02028494
Eligibility Criteria:
Inclusion Criteria:
* 1 Subject Inclusion Criteria
* Informed consent has been obtained.
* Metastatic breast cancer.
* Measurable or non-measurable disease per RECIST criteria.
* Pathologic confirmation of breast cancer.
* No limit to the number of prior chemotherapy regimens permitted for metastatic disease.
* At least 3 weeks since prior chemotherapy. Patients should have recovered from all acute toxicity from such therapy (excluding alopecia).
* Age ≥18.
* ECOG 0-2
* Absolute Neutrophil Count (ANC )≥1.0; hemoglobin ≥9, platelets
≥75.000
* AST, ALT and Alkaline phosphatase \<2.5x upper limit of normal (or \<5x upper limit of normal in the case of liver metastases). Total bilirubin \<1.5x upper limit of normal.
* Estimated creatinine clearance \>50ml/min.
* If female of childbearing potential, pregnancy test is negative and the patient agrees to use an effective method to avoid pregnancy during the study.
Exclusion Criteria:
* HER2 over-expression and/or amplification as determined by immunohistochemistry (3+) or FISH (\>2.0).
* No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if \>12 months have elapsed since treatment.
* No restriction for prior hormonal therapy.
* GI malabsorption syndrome which could impair oral drug absorption.
* Concurrent use of warfarin is discouraged as drug interactions may make management of INR more difficult.
* Central nervous system metastases are permitted if previously treated or clinically stable for at least 3 months.
* Pregnant or nursing patients.
* Life expectancy \<3 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02028494
Study Brief:
Protocol Section:
NCT02028494