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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Utidelone plus capecitabine
DrugUTD2 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.
Capecitabine
DrugCapecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Utidelone plus capecitabineExperimental treatment 1 intervention
Group B: CapecitabineActive comparator 1 intervention
Trial outcomes
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.
Time frame
36 monthsSecondary outcomes
1
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.
Time frame
60 months2
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
Time frame
36 months3
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
Time frame
60 months4
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Collect all participants' adverse event data and classify and assess them according to the CTCAE v4.0 criteria. This includes documenting the type of adverse event, severity (Grade 1-5), duration, and whether it is related to the study treatment. Data collection can be conducted through electronic health records, patient reports, or investigator reports, among other methods.
Time frame
24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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