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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: capecitabine

• Study Type: Observational
• Enrollment (Estimated): 1166

Contacts and Locations

• Study Contact: Name: yuan peng, doctor; Phone Number: 86+13671287670; Email: 13671287670@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Principal Investigator: Shu Wang
      • Contact: yuan peng, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Triple negative patients, non-PCR after neoadjuvant therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
6-8 cycles full dose capecitabine; 6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W)	Drug: capecitabine; different methods of treatment for capecitabine
1-year metronomic capecitabine; 1-year capecitabine metronomic chemotherapy (650mg/m2,BID)	Drug: capecitabine; different methods of treatment for capecitabine
no other chemotherapy; no other chemotherapy besides neoadjuvant therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease free survival	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.	5 years
distant disease free survival	Time from study enrollment to distant recurrence and metastasis	5 years
breast cancer specific survival	Time from study enrollment to death due to breast cancer	5 years
overall survival	Time from study enrollment to death from any cause	5 years

Collaborators and Investigators

• Sponsor: Shu Wang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: capecitabine; neoadjuvant chemotherapy; adjuvant chemotherapy; non-pCR
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Capecitabine
• Other Study ID Numbers: PKUPH2024Z167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No