Clinical trial Recruiting at 1 site Observational

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

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

Run by Peking University People's Hospital · NCT06700382 · Data updated 2026-11-12

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.

More Triple Negative Breast Cancer trials

Quick facts

Study typeObservational
SexAll
Enrollment1166 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedDecember 31, 2031
Study endsDecember 31, 2031
Registry record updatedNovember 25, 2024
Trial IDNCT06700382 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.