Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT07021261
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.
Detailed Description:
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:
NCT07021261
Study Brief:
Protocol Section:
NCT07021261