Quadratic Phenotypic Optimisation Platform (QPOP) Utilisation to Enhance Selection of Patient Therapy Through Patient Derived Organoids in Breast Cancer
Based on proof-of-concept study, the investigators hypothesise that the QPOP prediction model can be further extended into use in solid tumors. Using breast cancer as a model, the investigators intend to investigate the feasibility of QPOP as a clinical decision support platform to identify patient-specific drug combinations across a range of breast cancer patients. The investigators propose a pilot phase I clinical study to test the feasibility of using QPOP to guide therapy in patients with advanced breast cancer.
• Age \>= 21 years.
• Histological confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and HER2 receptor status)
• ECOG 0-1.
• At least 1 tumour lesion (primary or metastatic) amenable to fresh biopsy
• At least 1 measurable tumour lesions based on RECIST 1.1 criteria
• Estimated life expectancy of at least 12 weeks.
• Has documented progressive disease from last line of therapy.
• Has received at least 1 line of palliative systemic therapy
• Expected adequate organ function (bone marrow, hepatic, renal) after recovering from treatment-induced acute toxicities at the time of study treatment.
• Signed informed consent from patient or legal representative.
• Able to comply with study-related procedures.
⁃ Patients may be included in the study only if they meet all of the following criteria:
⁃ • Adequate organ function including the following:
⁃ Bone marrow:
• Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L
• Platelets \>= 100 x 109/L
• Hemoglobin \>= 8 x 109/L
⁃ Hepatic:
• Bilirubin \<= 1.5 x upper limit of normal (ULN),
• ALT or AST \<= 2.5x ULN, (or \<=5 X with liver metastases)
⁃ Renal:
⁃ \- Creatinine \<= 1.5x ULN