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NCT Number: NCT06700382

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

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.

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

shu wang

PRINCIPAL_INVESTIGATOR

yuan peng, Dr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

different methods of treatment for capecitabine

Primary outcomes

  1. disease free survival

    Time frame: 5 years

    The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.

Secondary outcomes

  1. invasive disease free survival

    Time frame: 5 years

    The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.

  2. distant disease free survival

    Time frame: 5 years

    Time from study enrollment to distant recurrence and metastasis

  3. breast cancer specific survival

    Time frame: 5 years

    Time from study enrollment to death due to breast cancer

  4. overall survival

    Time frame: 5 years

    Time from study enrollment to death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

yuan peng, doctor

CONTACT

[email protected]

86+13671287670

Sponsors and collaborators

Lead sponsor

Shu Wang

Other

Registry information

Official study title

A Cohort Study of Different Methods of Adjuvant Capecitabine Regimens in Patients With Non-PCR After Neoadjuvant Therapy for Triple Negative Breast Cancer

Acronym: NeoTNBCX

Important dates

Study start
2019
Primary completion
2031
Study completion
2031
First posted
Nov 22, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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