Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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).
Surgical Resection Underwent complete surgical resection (R0) with pathologically confirmed negative margins.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Utidelone plus capecitabine
- Capecitabine
Treatment groups
440 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov