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Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC

Study acronym: NeoTNBCX
StatusRecruiting
PhaseNot specified
SponsorShu Wang
Started2019-01-01
View on ClinicalTrials.gov ↗

Amendment history

2024-11-21
minor
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2024-11-20
minor
Original filing
The survival rate of patients with pathological complete response (pCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-pCR patients. Therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pCR after neoadjuvant chemotherapy can further improve the survival of this population. Previous studies have given capecitabine treatment to such patients as standard. However, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; Whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. This study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with T2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.
Trial Details
NCT Number NCT06700382
Lead Sponsor Shu Wang
Conditions Triple Negative Breast Cancer
Enrollment 1,166 participants
Start Date 2019-01-01
Primary Completion 2031-12-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-25