Actively Recruiting

All Genders
NCT06700382

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

Led by Shu Wang · Updated on 2024-11-25

1166

Participants Needed

1

Research Sites

678 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with triple negative breast cancer diagnosed by biopsy at Peking University People's Hospital
  • Clinical stages before treatment were T1-T4, N0-N3, M0
  • Received treatment and surgery at Peking University People's Hospital with hospitalization records
  • Neoadjuvant chemotherapy is allowed without limit; immunotherapy allowed in neoadjuvant and/or adjuvant treatment
  • Postoperative pathology confirms residual invasive breast cancer in breast and/or axillary lymph nodes
  • Signed and agreed to participate in the PKUPH breast disease cohort study
Not Eligible

You will not qualify if you...

  • Missing clinical or pathological data such as imaging or pathology reports
  • Presence of metastatic or bilateral breast cancer
  • Failure to perform radical surgery
  • Pathogenic or possibly pathogenic BRCA mutations with postoperative intensive PARP inhibitor treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

Y

yuan peng, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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