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

NCT ID: NCT06700382

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2031-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

6-8 cycles full dose capecitabine

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

capecitabine

Intervention Type: DRUG

different methods of treatment for capecitabine

1-year metronomic capecitabine

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

capecitabine

Intervention Type: DRUG

different methods of treatment for capecitabine

no other chemotherapy

no other chemotherapy besides neoadjuvant therapy

No interventions assigned to this group

Interventions

capecitabine

different methods of treatment for capecitabine

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shu Wang

OTHER

Sponsor Role: lead

Responsible Party

Shu Wang

director of breast center

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

yuan peng, doctor

Role: CONTACT

13671287670@163.com

86+13671287670

Facility Contacts

yuan peng, Dr

Role: primary

Other Identifiers

PKUPH2024Z167

Identifier Type: -

Identifier Source: org_study_id