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

NCT07021261 | Not Yet Recruiting Phase 3

• 1 other identifier: BG02-T2401
• Study Type: interventional
• Target: 440
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the IDFS rate, overall survival (OS) rate, and safety profile of UTD2 combined with capecitabine versus capecitabine monotherapy as adjuvant therapy for triple-negative early breast cancer patients who did not achieve pathological complete response (pCR) after neoadjuvant therapy.

Conditions

Breast Cancer; TNBC

Outcome Measures

Primary Outcomes (1)

• 3-year invasive disease-free survival(IDFS)

  defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.In-situ events are not included.

  36 months

Secondary Outcomes (4)

• invasive disease-free survival(IDFS)

  60 months

• overall survival (OS)

  36 months

• overall survival (OS)

  60 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  24 months

Study Arms (2)

Utidelone plus capecitabine

EXPERIMENTAL

UTD2 50 mg/m²/day orally on Days 1-5, repeated every 21 days for 2 years; Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

Drug: Utidelone plus capecitabine

Capecitabine

ACTIVE COMPARATOR

Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

Drug: Capecitabine

Interventions

Utidelone plus capecitabine DRUG

UTD2 50 mg/m²/day orally on Days 1-5, repeated every 21 days for 2 years; Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

Also known as: UTD2 plus capecitabine

Utidelone plus capecitabine

Capecitabine DRUG

Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.

Capecitabine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):

You may not qualify if:

• 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.
• 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).
• 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.
• Pregnancy (positive pregnancy test) or lactation.
• Concurrent participation in another interventional clinical study or receiving other investigational therapies.
• Concomitant use of potent CYP3A4 inhibitors/inducers or QT-prolonging drugs within 14 days prior to the first dose or during the study.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Breast Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 13, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 16, 2030
• Study Completion (Estimated): June 16, 2032
• Last Updated: June 13, 2025

Record last verified: 2025-06