protocolSection identificationModule nctId: NCT06313463, orgStudyIdInfo id: SYSKY-2023-1282-02, briefTitle: Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2031-09, completionDateStruct date: 2035-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients.The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy., conditionsModule conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: Carrellizumab + Capecitabine, interventions name: Placebo + Capecitabine, outcomesModule primaryOutcomes measure: Disease-Free Survival, secondaryOutcomes measure: Invasive Disease-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Distant Recurrence-Free Interval, secondaryOutcomes measure: Patient-reported outcomes-Proportion of patients in each group experiencing clinically meaningful deterioration, secondaryOutcomes measure: Patient-reported outcomes-EORTC QLQ-C30 scores after treatment, secondaryOutcomes measure: Patient-reported outcomes-EORTC QLQ-C30 scores changes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Shicheng Su, M.D., Ph.D., role: CONTACT, phone: +86 13632394954, email: lnl_trial@126.com, contacts name: Erwei Song, M.D., Ph.D., role: CONTACT, phone: +86 13719237746, email: lnl_trial@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False