Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients

Prior treatment

• Radiotherapy within 2 weeks prior to the first dose of the study drug.
• Surgery within 2 weeks prior to the first dose of the study drug.
• Prior treatment with utidelone or capecitabine, known hypersensitivity to utidelone, capecitabine, or fluoropyrimidines, or confirmed dihydropyrimidine dehydrogenase (DPD) deficiency.
• Prior adverse reactions to anticancer therapy have not recovered to CTCAE v5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, such as alopecia).
• Concurrent participation in another interventional clinical study or receiving other investigational therapies.

Other illness

• Stage IV metastatic breast cancer.
• Bilateral breast cancer.
• History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.
• Gastrointestinal disorders (e.g., esophageal obstruction, pyloric obstruction, intestinal obstruction), post-gastrointestinal resection, or other factors causing dysphagia that may interfere with oral drug absorption.
• Severe comorbidities, including significant cardiac/cerebrovascular disease, uncontrolled diabetes/hypertension, active infections, or active peptic ulcer.
• Active hepatitis B virus (HBV) infection.
• History of immunodeficiency (e.g., HIV-positive status, congenital/acquired immunodeficiency disorders) or organ transplantation.
• Psychiatric disorders or poor compliance.
• Other conditions deemed unsuitable for study participation by the investigator.

Lab values

• Concomitant use of potent CYP3A4 inhibitors/inducers or QT-prolonging drugs within 14 days prior to the first dose or during the study.

Other

• Pregnancy (positive pregnancy test) or lactation.

• Informed Consent and Compliance The patient has fully understood this study and voluntarily signed the informed consent form, demonstrating the ability and willingness to comply with the study protocol-defined visits, treatment plans, laboratory tests, and other study procedures.
• Age and Gender Female patients aged 18 to 70 years old (inclusive) on the day of signing the informed consent.
• Prior Neoadjuvant Chemotherapy without pCR Received prior neoadjuvant chemotherapy containing anthracycline or taxane agents without achieving pathological complete response (pCR).
  • Neoadjuvant chemotherapy requirement: At least 4 completed cycles. Non-pCR definition: Residual invasive carcinoma confirmed by pathology after primary tumor resection.
• Surgical Resection Underwent complete surgical resection (R0) with pathologically confirmed negative margins.
• Triple-Negative Breast Cancer Confirmation
  • Post-resection tumor tissue confirmed as ER-negative, PR-negative, and HER2-negative breast cancer by immunohistochemistry (IHC):
  • ER-negative: \<1% expression by IHC. PR-negative: \<1% expression by IHC. HER2-negative: IHC score of 0 or 1+, or 2+ with negative in situ hybridization (ISH) results.
• Postoperative Treatment No prior systemic anticancer therapy (excluding radiotherapy) after breast cancer surgery.
• Performance Status ECOG performance status of 0 to 1.
• Hematological Criteria (within 1 week prior to enrollment)
  • Blood tests meet the following criteria (CTCAE v5.0 ≤ Grade 1, based on institutional laboratory standards):
  • White blood cell (WBC) count ≥ 3.0 × 10\^9/L. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L. Platelet (PLT) count ≥ 100 × 10\^9/L. Hemoglobin ≥ 9.0 g/dL. No administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF), blood products, or erythropoietin (EPO) within 14 days prior to enrollment.
• Biochemical Criteria (within 1 week prior to enrollment)
  • Normal blood biochemistry (CTCAE v5.0 ≤ Grade 1, based on institutional laboratory standards):
  • Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN). Alanine aminotransferase (ALT) ≤ 1.5 × ULN. Aspartate aminotransferase (AST) ≤ 1.5 × ULN. Alkaline phosphatase (ALP) ≤ 2.5 × ULN. Creatinine clearance (Ccr) ≥ 50 mL/min. Contraception Requirements Fertile patients must agree to use highly effective contraception (hormonal, barrier methods, or abstinence) with their partners during the trial and for at least 6 months after the last dose. Premenopausal female patients must have a negative blood or urine pregnancy test before enrollment.