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

NCT06700382 | Recruiting

• 1 other identifier: PKUPH2024Z167
• Study Type: observational
• Target: 1,166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Triple Negative Breast Cancer

Keywords

neoadjuvant chemotherapy; adjuvant chemotherapy; non-pCR; capecitabine

Outcome Measures

Primary Outcomes (1)

• disease free survival

  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.

  5 years

Secondary Outcomes (4)

• invasive disease free survival

  5 years

• distant disease free survival

  5 years

• breast cancer specific survival

  5 years

• overall survival

  5 years

Study Arms (3)

6-8 cycles full dose capecitabine

6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W)

Drug: capecitabine

1-year metronomic capecitabine

1-year capecitabine metronomic chemotherapy (650mg/m2,BID)

Drug: capecitabine

no other chemotherapy

no other chemotherapy besides neoadjuvant therapy

Interventions

capecitabine DRUG

different methods of treatment for capecitabine

1-year metronomic capecitabine; 6-8 cycles full dose capecitabine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Triple negative patients, non-PCR after neoadjuvant therapy

You may qualify if:

• \) Patients with triple negative breast cancer diagnosed by biopsy in Peking University People's Hospital;
• \) The clinical stages before treatment were T1-T4, N0-N3, M0;
• \) Received treatment and operation in our hospital, and had hospitalization records;
• \) Neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment;
• \) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or axillary lymph nodes;
• \) Has signed and agreed to participate in the PKUPH breast disease cohort study.

You may not qualify if:

• \) Lack of clinical and pathological data (such as imaging data and pathological data);
• \) Patients with metastatic breast cancer or bilateral breast cancer;
• \) Failure to perform radical surgery;
• \) BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation

Sponsors & Collaborators

• Shu Wang: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

yuan peng, doctor

CONTACT

86+13671287670; 13671287670@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of breast center

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)