Comparing capecitabine treatments for patients with residual triple negative breast cancer after initial therapy

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

This study is testing two different ways of giving capecitabine to people with triple negative breast cancer who didn't fully respond to their initial treatment to see which one works better and has fewer side effects.

Quick facts

• Study type: Observational
• Enrollment: 1166 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06700382 on ClinicalTrials.gov

What this trial studies

This observational study investigates the efficacy and safety of two different capecitabine treatment regimens in patients with triple negative breast cancer who have not achieved a pathological complete response after neoadjuvant therapy. It compares a standard intensive regimen of 6-8 cycles of full-dose capecitabine with a metronomic chemotherapy approach lasting one year. The study aims to determine if the standard regimen remains effective in the context of prior immunotherapy. Patients will be monitored for treatment outcomes and side effects.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with triple negative breast cancer who have undergone neoadjuvant chemotherapy and have residual invasive cancer post-surgery.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those with specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with triple negative breast cancer who have residual disease after initial therapy.

How similar studies have performed: Previous studies have shown that intensive adjuvant therapy can improve survival in similar patient populations, but this specific comparison of capecitabine regimens is novel.

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

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: yuan peng, doctor

Conditions Triple Negative Breast Cancer; neoadjuvant chemotherapy; adjuvant chemotherapy; non-pCR; capecitabine