protocolSection identificationModule nctId: NCT06278870, orgStudyIdInfo id: SYSKY-2023-431-02, briefTitle: Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-06, primaryCompletionDateStruct date: 2031-06-30, completionDateStruct date: 2031-06-30, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer., conditionsModule conditions: HER2-positive Metastatic Breast Cancer, conditions: First-line Treatment, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: disitamab vedotin, interventions name: Pyrotinib, interventions name: trastuzumab, interventions name: Pertuzumab, interventions name: taxane drug, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Clinical Benefit rate (CBR), secondaryOutcomes measure: Adverse Events (Based on CTCAE 5.0 standards), secondaryOutcomes measure: Quality of Life (QoL) by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B), secondaryOutcomes measure: Exploration of biomarkers, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 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: 510000, country: China, contacts name: Herui Yao, PhD, role: CONTACT, phone: +86 13500018020, email: yaoherui@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False