Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy
This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.
• Signed informed consent;
• 18 Years and older;
• Female;
• Breast cancer confirmed by pathological histology, ER-negative (\<1% positive), PR-negative (\<1% positive), and HER2-negative (IHC: HER2 (0), HER2 (1+), or HER2 (2+) and FISH non-amplification;
• Patients must receive full course of neoadjuvant chemotherapy before surgery and did not achieve pathological complete response (i. e., pathologically confirmed residual lesion, maximum diameter of 1cm) or / lymph node positive (ypN+);
• Previous neoadjuvant chemotherapy regimen included anthracycline, taxane, or a combination of both.
• Patients who clinically require radiotherapy of the affected breast or chest wall and regional lymph node area should receive radiotherapy before or after study medication;
• All toxicities related to previous antitumor therapy must return to Grade 1 (CTCAE v5.0), except alopecia;
• Within 1 week before enrollment, the blood routine examination was basically normal (taking the normal value of each study center as the standard): 1) Blood routine: hemoglobin (Hb) \> 90g / L, White blood cell count (WBC) \> 3.5\*10\^9 / L, Number of neutrophils (ANC) \* 1.5\*10\^9 / L, Platelet count (PLT)\* 100\*10\^9 / L; 2) Renal function: upper limit of normal serum creatinine value; 3) Liver function: for patients without liver metastasis: glutamulate aminotransferase (AST), glutamate aminotransferase (ALT), alkaline phosphatase (ALP) are less than 2.5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value; for patients with liver metastasis, AST, ALT, ALP, ALT, ALP, are less than 5 times of the upper limit of normal value, and totle bilirubin is less than 1.25 times of the upper limit of normal value;
• The ECOG physical status score for patients must be 0 or 1;