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

Recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Drug: capecitabine

• Registration Number: NCT06700382
• Lead Sponsor: Shu Wang

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 popu...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-25
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1166

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
6-8 cycles full dose capecitabine	capecitabine	6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W)
1-year metronomic capecitabine	capecitabine	1-year capecitabine metronomic chemotherapy (650mg/m2,BID)

Primary Outcome Measures

Name	Time	Method
disease free survival	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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China