NCT06700382Recruiting
Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC
A Cohort Study of Different Methods of Adjuvant Capecitabine Regimens in Patients With Non-PCR After Neoadjuvant Therapy for Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1166 (estimated)
- First submitted
- 20 Nov 2024
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Shu Wang
- NCT number
- NCT06700382
What you commit to
- Study type: Observational
- Planned participants: 1166
- From 1 Jan 2019 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 4\) BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation
Other illness
- 2\) Patients with metastatic breast cancer or bilateral breast cancer;
- 3\) Failure to perform radical surgery;
Other
- 1\) Lack of clinical and pathological data (such as imaging data and pathological data);
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.