Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-28 @ 4:32 AM
Study NCT ID:
NCT07021261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing UTD2 Combined With Capecitabine to Capecitabine as Adjuvant Therapy for Non-pCR TNBC Patients
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Randomized, Phase III Study Comparing UTD2 Combined With Capecitabine to Capecitabine Monotherapy as Adjuvant Therapy for Triple-Negative Breast Cancer Patients Who Did Not Achieve Pathological Complete Response
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: