:Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients With Metastatic Breast Cancer
This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients. This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.
• Voluntarily participate in this study, sign an informed consent form, have good compliance, and are willing to follow-up.
• Female, aged ≥ 18 and ≤ 70 years, with an ECOG score of 0-1 and an expected survival time of ≥ 12 weeks.
• The pathological and/or cytological diagnosis (based on the latest biopsy results) is HER2 negative recurrent or metastatic breast cancer, regardless of hormone receptor status (ER/PR positive or negative, but the hormone receptor status needs to be determined);
• All patients have received at least paclitaxel and/or anthracycline as a treatment option;
• All patients with prior treatment ≤ 3 lines (for those who progress during the neoadjuvant/adjuvant period or within 12 months after the end of the last treatment, it is considered as the first line, and no progress is counted as the number of lines); For HR+/HER2- breast cancer patients, they also need to have received the first line systemic CDK4/6 inhibitor+endocrine therapy before the disease progresses.
• According to RECIST 1.1 standard, there is at least one measurable extracranial lesion present.
• Within one week before enrollment, the blood routine examination was basically normal (no blood transfusion within two weeks, no use of drugs to increase white blood cells or platelets):
• Neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 90 × 109/L; Hemoglobin ≥ 9.0 g/dL.
• Within one week before enrollment, the blood biochemistry test was basically normal (based on the normal values of each research center laboratory): Total bilirubin (TBIL) ≤ 1.5 x Upper limit of normal value (ULN) SGPT/ALT ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); SGOT/AST ≤ 3 × ULN (liver metastasis patients ≤ 5 × ULN); The creatinine clearance rate (Ccr) is ≥ 50 ml/min (Cockcroft Gault formula).
• No major organ dysfunction
⁃ Women with fertility must agree to use effective contraceptive methods during the study period and within 6 months after the last study medication. Women with fertility must have a negative blood or urine pregnancy test before enrollment.