NCT06700382 Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC
| NCT ID | NCT06700382 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shu Wang |
| Condition | Triple Negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,166 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,166 participants in total. It began in 2019-01-01 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06700382 clinical trial?
This trial is open to participants of all sexes, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06700382 currently recruiting?
Yes, NCT06700382 is actively recruiting participants. Contact the research team at 13671287670@163.com for enrollment information.
Where is the NCT06700382 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06700382 clinical trial?
NCT06700382 is sponsored by Shu Wang. The trial plans to enroll 1,166 participants.
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