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.
This is a prospective, randomized, open-label phase III clinical study that aims to evaluate the efficacy and safety of the combination therapy involving the use of oral UTD2 capsule in conjunction with capecitabine, as compared to the efficacy and safety of capecitabine monotherapy. The study is specifically focused on patients diagnosed with triple-negative early breast cancer who, after undergoing neoadjuvant therapy, did not achieve a pathological complete response (pCR). The primary objective of this research is to assess whether the addition of UTD2 to capecitabine can provide a more effective adjuvant treatment option for this particular group of patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
440
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.
Capecitabine 1000 mg/m² twice daily on Days 1-14, repeated every 21 days for 8 cycles.
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 months
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 months
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
Time frame: 36 months
overall survival (OS)
the time from treatment to death, regardless of disease recurrence
Time frame: 60 months
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 months
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