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Search / Trial NCT06700382

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

Launched by SHU WANG · Nov 20, 2024

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

Neoadjuvant Chemotherapy Adjuvant Chemotherapy Non P Cr Capecitabine

ClinConnect Summary

This clinical trial is investigating two different ways of administering a medication called capecitabine for patients with early-stage triple negative breast cancer who still have tumor cells present after their initial treatment. Researchers want to find out if giving a full dose of capecitabine for 6 to 8 cycles is more effective and safe compared to a lower, continuous dose of capecitabine given over one year. The goal is to see which method helps improve survival rates for patients who did not achieve a complete response to their previous treatments.

To participate, individuals must be diagnosed with triple negative breast cancer, have specific tumor characteristics, and show evidence of remaining invasive cancer after their initial treatment. Participants can expect to receive either the standard or metronomic (lower dose) capecitabine treatment, and they will be closely monitored for safety and effectiveness throughout the trial. Importantly, this study is currently recruiting participants, and it allows for those who have received immunotherapy during their earlier treatment stages.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1) Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
  • 2) The clinical stages before treatment were T1-T4, N0-N3, M0;
  • 3) Received treatment and operation in our hospital, and had hospitalization records;
  • 4) Neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment;
  • 5) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or axillary lymph nodes;
  • 6) Has signed and agreed to participate in the PKUPH breast disease cohort study.
  • Exclusion Criteria:
  • 1) Lack of clinical and pathological data (such as imaging data and pathological data);
  • 2) Patients with metastatic breast cancer or bilateral breast cancer;
  • 3) Failure to perform radical surgery;
  • 4) BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation

About Shu Wang

Shu Wang is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on developing cutting-edge treatments across various therapeutic areas, Shu Wang emphasizes rigorous scientific methodologies and ethical standards in all clinical trials. The organization is driven by a passion for enhancing healthcare through collaboration with researchers, healthcare professionals, and regulatory bodies, ensuring that each study is designed to meet the highest quality benchmarks while addressing unmet medical needs. Through its strategic approach and commitment to excellence, Shu Wang aims to contribute significantly to the future of medicine.

Locations

Beijing, Beijing, China

Beijing, Beijing. Pr, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported