A Study of Trifluridine/Tipiracil in Triple Negative Metastatic Breast Cancer

Inclusion Criteria

• •Age ≥ 18 years
• •Life expectancy of ≥ 3 months
• •Histologically or cytologically confirmed locally recurrent or metastatic breast cancer that is Estrogen receptor negative, Progesterone receptor negative, and HER2 normal on local testing
• •Up to three prior chemotherapy regimens for advanced and/or metastatic disease
• •Prior therapy with an anthracycline and a taxane in the adjuvant or metastatic setting or documented unsuitability
• •Patients who developed advanced or metastatic disease within 6 months of completing adjuvant therapy are eligible with no prior therapy for advanced disease.
• •Resolution of all chemotherapy- or radiation-related toxicities to ≤ grade 1 (except for stable sensory neuropathy ≤ grade 2 and alopecia) prior to commencement of study participation
• •Eastern Cooperative Oncology Group performance status of 0 to 2
• •Adequate renal function: creatinine clearance ≥ 40 mL/min Cockcroft and Gault formula
• •Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin \<10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count ≥ 100 x 10\^9/L
• •Adequate liver function: bilirubin ≤ 1.5 times the upper limits of normal (ULN), alanine aminotransferase (ALT ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN)
• •Measurable disease (RECIST 1.1)
• •Patients with known central nervous system (CNS) disease are eligible provided all of the following criteria are met:
• •* Measurable disease outside the CNS
• •* Metastases are limited solely to cerebellar and supratentorial lesions (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
• •* If corticosteroids are required, the patient must be on a stable dose or tapering dose of corticosteroids for 4 weeks prior to enrolment as therapy for CNS disease
• •* Anticonvulsants at a stable dose are allowed as long as the patient has been seizure free for 3 weeks prior to enrolment
• •* No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to randomization
• •* No evidence of progression or haemorrhage after completion of CNS directed therapy
• •* Note: Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible, if all other criteria above are met.
• •Women of child-bearing potential and males with female partners with child bearing potential must use highly effective contraceptive measures while taking Trifluridine/tipiracil and for 6 months after stopping treatment. Trifluridine/tipiracil may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier contraceptive method.
• •Ability to understand and the willingness to sign a written informed consent document.
• •Ability to take and retain oral medications