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

Launched by FUDAN UNIVERSITY · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with early-stage triple-negative breast cancer (TNBC) who did not achieve a complete response to previous chemotherapy. The researchers want to compare two treatment options: one group will receive a combination of UTD2 and capecitabine, while the other group will receive capecitabine alone. The goal is to see which option leads to better outcomes in terms of disease-free survival and overall survival, as well as to assess the safety of these treatments.

To participate in the trial, women aged 18 to 70 who have undergone previous chemotherapy without achieving a complete response are eligible, provided they have undergone surgery to remove the cancer and have confirmed triple-negative breast cancer. Participants will be closely monitored during the study, which is not yet recruiting. It's important to note that women who are pregnant, have certain health conditions, or who are currently receiving other treatments may not qualify for this trial. This study aims to find potentially more effective treatment options to improve the health and outcomes for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Age and Gender Female patients aged 18 to 70 years old (inclusive) on the day of signing the informed consent.
• • 3. 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.
• • 4. Surgical Resection Underwent complete surgical resection (R0) with pathologically confirmed negative margins.
• • 5. 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.
• • 6. Postoperative Treatment No prior systemic anticancer therapy (excluding radiotherapy) after breast cancer surgery.
• • 7. Performance Status ECOG performance status of 0 to 1.
• • 8. 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.
• • 9. 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.
• Exclusion Criteria:
• • 1. Stage IV metastatic breast cancer.
• • 2. Bilateral breast cancer.
• • 3. 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.
• • 4. Radiotherapy within 2 weeks prior to the first dose of the study drug.
• • 5. Surgery within 2 weeks prior to the first dose of the study drug.
• • 6. Prior treatment with utidelone or capecitabine, known hypersensitivity to utidelone, capecitabine, or fluoropyrimidines, or confirmed dihydropyrimidine dehydrogenase (DPD) deficiency.
• • 7. 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).
• • 8. 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.
• • 9. Severe comorbidities, including significant cardiac/cerebrovascular disease, uncontrolled diabetes/hypertension, active infections, or active peptic ulcer.
• • 10. Active hepatitis B virus (HBV) infection.
• • 11. History of immunodeficiency (e.g., HIV-positive status, congenital/acquired immunodeficiency disorders) or organ transplantation.
• • 12. Psychiatric disorders or poor compliance.
• • 13. Pregnancy (positive pregnancy test) or lactation.
• • 14. Concurrent participation in another interventional clinical study or receiving other investigational therapies.
• • 15. Concomitant use of potent CYP3A4 inhibitors/inducers or QT-prolonging drugs within 14 days prior to the first dose or during the study.
• • 16. Other conditions deemed unsuitable for study participation by the investigator.