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.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 1166 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2019 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT06700382 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
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pre-Treatment Breast DCE-MRI AI Model to Predict Benefit from Neoadjuvant Chemo in Locally Advanced Triple-Negative Breast Cancer
This study tests an AI model using pre-treatment breast MRI to see if it can identify which locally advanced triple-negative breast cancer patients will benefit most from neoadjuvant chemotherapy.
-
JS212-based therapy for recurrent/metastatic TNBC: as monotherapy or with partners
This phase 2 study tests JS212 alone or with JS207 or JS001 to see if it helps people with recurrent or metastatic triple-negative breast cancer.
-
Imaging study of [68Ga]Ga-DWJ155 in adults with solid tumors
This trial tests a new radioligand imaging agent, [68Ga]Ga-DWJ155, to see how well it images tumors and how safe it is in adults with advanced solid cancers.
-
Can older adults with breast cancer tolerate a dense CMF chemo schedule
This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.
-
Oral paclitaxel in triple-negative breast cancer before main chemotherapy
This trial tests whether giving an oral paclitaxel dose-6 in combination with standard epirubicin and cyclophosphamide can be tolerated in women with triple-negative breast cancer before surgery.
-
Granzyme B-PET to see if immunotherapy works in TNBC
This study will test whether a Granzyme B PET/CT scan can help predict how well immunotherapy will work for adults with locally advanced or metastatic triple-negative breast cancer receiving an immune checkpoint inhibitor.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.