protocolSection identificationModule nctId: NCT06328387, orgStudyIdInfo id: SYSKY-2024-064-03, briefTitle: HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Advanced breast cancer is a special subtype of human breast cancer. Conventional guidelines recommend chemotherapy combined with other adjuvant therapies for this subtype of patients. However, the choice of treatment for these patients after treatment progress is a research hotspot in this field. Trastuzumab Deruxtecan (T-DXd) and Sacituzumab Govitecan (SG) are new ADC drugs targeting HER2 or TROP-2 with high efficacy and low toxicity after the progress of first-line treatment. The autophagy agents hydroxychloroquine or chloroquine has become the only FDA (Food and Drug Administration) approved autophagy inhibitor, and hydroxychloroquine and antibody-drug conjugate(ADC) may have synergistic effects based on the previous work results of our research group.Therefore,we envisage that Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the advantages of improving efficacy and survival.To this end, we intend to conduct a prospective,multi-center, phase I/II clinical trial to evaluate the efficacy and safety of T-DXd or SG in combination with HCQ in patients with advacned breast cancer., conditionsModule conditions: Advanced Breast Cancer, conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research model consists of four arms：1. arm A: SG.2. arm B: HCQ+SG.3. arm C: T-DXd .4. arm D: HCQ+T-DXd., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine, interventions name: Sacituzumab Govitecan, interventions name: Trastuzumab Deruxtecan, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity, DLT, primaryOutcomes measure: Adverse event, AE, primaryOutcomes measure: Objective Response Rate, ORR, secondaryOutcomes measure: Progression-Free Survival, PFS, secondaryOutcomes measure: Overall Survival, OS, secondaryOutcomes measure: Clinical Benefit Rate, CBR, secondaryOutcomes measure: Disease Control Rate, DCR, secondaryOutcomes measure: The rate of adverse events, secondaryOutcomes measure: Quality of life scale score, QoL, secondaryOutcomes measure: Exploration of biomarkers, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 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: Jianli J Zhao, doctorate, role: CONTACT, phone: 15920589334, email: zhaojli5@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False