Phase I/II, Evaluate the Safety and Efficacy of BLEX 404 With Docetaxel in Patients With Advanced/Metastatic Triple Negative Breast Cancer.

Inclusion Criteria

• •1. Females aged 20 - 70 years old at the time of signing the ICF.
• •2. Patients with histologically or pathologically diagnosed with advanced/metastatic triple negative (ER-, PR-, and HER2-negative) breast cancer.
• •1. ER =\< 10% by immunohistochemistry (IHC) tumor staining;
• •2. PR =\< 10% by IHC tumor staining;
• •3. HER2-negative defined as one of the following: 0 or 1+ by IHC, or 2+ by IHC and fluorescence in situ hybridization (FISH)-negative (ratio \< 2.0).
• •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• •4. Adequate hematologic function defined as: absolute neutrophil count (ANC) greater than or equal to 2,000/μL; platelets count greater than or equal to 100,000/μL; hemoglobin must be greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion).
• •5. Adequate hepatic function defined as: serum bilirubin less than or equal to 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) less than or equal to 3-fold ULN.
• •6. Adequate renal function with: serum creatinine less than or equal to 1.3 mg/dL or calculated creatinine clearance greater than or equal to 60 mL/minute according to the Cockcroft and Gault formula.
• •7. Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), from time of Screening Visit until 30 days after study drug discontinuation.
• •8. Planning to receive Docetaxel monotherapy.
• •9. Willing and able to comply with all aspects of the treatment protocol.
• •10. Provide written informed consent.