Clinical trial NCT06700382: Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
Keywords: neoadjuvant chemotherapy
adjuvant chemotherapy
non-pCR
capecitabine
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 1166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Triple negative patients, non-PCR after neoadjuvant therapy

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

Primary outcomes:
measure: disease free survival
timeFrame: 5 years
Secondary outcomes:
measure: invasive disease free survival
timeFrame: 5 years
measure: distant disease free survival
timeFrame: 5 years
measure: breast cancer specific survival
timeFrame: 5 years
measure: overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: