[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-positiveher2-low-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-positiveher2-low-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,76,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100643090","phase-2-neoadjuvant-dalpiciclib--ai--shr-a1811-for-hrher2-low-breast-cancer-100643090",false,"NCT07618923","Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+\u002FHER2-Low Breast Cancer","Dalpiciclib Combined With Aromatase Inhibitor (AI) Followed by SHR-A1811 as Neoadjuvant Therapy in Patients With Intermediate-to-High Risk HR+\u002FHER2-Low Breast Cancer: A Phase II Exploratory Study","TD-DASHER-01","Inclusion Criteria:\n\n1. Age ≥18 and ≤70 years\n2. Histologically confirmed invasive breast cancer, HR+ (ER ≥1% and\u002For PR ≥1%) and HER2-low (IHC 1+ or IHC 2+\u002FISH-)\n3. No prior systemic anti-tumor therapy for breast cancer\n4. Stage II-III (T1cN1-2M0, T2-4N0-2M0) per AJCC 8th edition\n5. At least one of the following intermediate-to-high risk factors:\n\n   * Axillary lymph node involvement ≥1\n   * Tumor size≥2 cm\n   * Grade 3 tumor\n   * Ki-67 ≥20%\n6. At least one measurable lesion per RECIST 1.1\n7. ECOG PS 0-1\n8. Adequate organ function (ANC ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, Hb ≥90 g\u002FL, TBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN, Cr ≤1.5×ULN or CrCl ≥60 mL\u002Fmin, LVEF ≥50%, QTcF ≤470 ms in females, DLCO ≥50% predicted\n9. Negative pregnancy test (for women of childbearing potential) and agreement to use adequate contraception during and for 6 months after treatment\n10. Willing and able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n1. Non-pathologically confirmed breast cancer\n2. Bilateral, inflammatory, or occult breast cancer\n3. Prior anticancer therapy (chemotherapy, radiotherapy, targeted therapy, endocrine therapy, etc.)\n4. Concurrent use of other anticancer treatments\n5. Other malignancy within 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)\n6. Participation in another interventional clinical trial within 4 weeks prior to first dose\n7. Use of immunosuppressive agents or systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to first dose\n8. Live or attenuated vaccine within 4 weeks prior to first dose\n9. Major surgery unrelated to breast cancer within 4 weeks prior to first dose\n10. Active or history of autoimmune disease requiring systemic treatment\n11. Known immunodeficiency (e.g., HIV positivity) or history of organ transplantation\n12. Uncontrolled or significant cardiovascular disease (e.g., NYHA class III\u002FIV heart failure, myocardial infarction, unstable angina, arrhythmia requiring treatment, QTcF \\>470 ms, uncontrolled hypertension)\n13. Known or suspected interstitial lung disease (ILD) or significant pre-existing pulmonary disease\n14. Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL) or hepatitis C (HCV RNA above ULN), cirrhosis, or uncontrolled severe infection\n15. Known bleeding or thrombotic tendency\n16. Allergy or contraindication to any study drug or excipient\n17. Pregnancy, breastfeeding, or positive pregnancy test at baseline\n18. Any concurrent condition that may compromise patient safety or study compliance (e.g., uncontrolled hypertension, severe diabetes, active infection)\n19. History of neurological or psychiatric disorders (e.g., epilepsy, dementia) or any condition deemed unsuitable by the investigator.","FEMALE","18 Years","70 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a phase II, single-arm, prospective exploratory study to evaluate the efficacy and safety of neoadjuvant dalpiciclib (a CDK4\u002F6 inhibitor) plus an aromatase inhibitor (AI) followed by SHR-A1811 (an anti-HER2 antibody-drug conjugate) in patients with intermediate-to-high risk, hormone receptor-positive (HR+), HER2-low breast cancer. Patients will receive dalpiciclib (125 mg orally once daily, days 1-21, every 4 weeks) plus AI (anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg once daily) for 4 cycles, followed by SHR-A1811 (4.8 mg\u002Fkg intravenously every 3 weeks) for 4 cycles. The primary endpoint is objective response rate (ORR) per RECIST 1.1. Secondary endpoints include pathological complete response (pCR), breast-conserving surgery rate, event-free survival (EFS), change in Ki-67 index, and safety. A total of 20 participants will be enrolled.",[28,29],"Breast Cancer","HR Positive\u002FHER2 Low Breast Cancer",[28,31,32,33,34,35],"HR-positive","HER2-low","Neoadjuvant Therapy","Dalpiciclib","SHR-A1811","NOT_YET_RECRUITING","2026-06-08",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":22},"2026-06",{"date":44,"type":22},"2029-01",{"name":46,"class":47},"Tang-Du Hospital","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100622453","phase-2-neoadjuvant-therapy-combined-with-trastuzumab-rezetecan-and-toripalimab-for-hrher2-low-breast-cancer-neotorch-breast-08-100622453","NCT07383818","Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+\u002FHER2-low Breast Cancer (NEOTORCH-BREAST 08)","A Prospective, Multigroup, Multi-center, Open-label Clinical Study of Trastuzumab Rezetecan as Neoadjuvant Therapy Combined With Toripalimab in HR+\u002FHER2-low Breast Cancer Patients (NEOTORCH-BREAST 08)","Inclusion Criteria:\n\n1. Female patients aged 18-70 years old;\n2. ECOG score is 0-1 points;\n3. Histologically or pathologically confirmed invasive breast cancer, meeting the following criteria simultaneously: Invasive breast cancer staged as T1cN1-2M0 or T2-3N0-2M0; All patients must be pathohistologically confirmed as HR-positive\u002FHER2-low. The interpretation of ER and PR status follows the 2020 ASCO\u002FCAP Guidelines: expression ≥1% is defined as positive, and HR positivity is confirmed if either ER or PR is positive. The interpretation of HER2 status follows the 2023 ASCO\u002FCAP Guidelines: HER2-low is defined as HER2 1+ or 2+ with negative FISH test results. Pathological testing for PD-L1 expression: The Combined Positive Score (CPS) is the percentage of PD-L1-positive cells (including tumor cells, lymphocytes, and macrophages) among the total number of tumor cells. The PD-L1 antibody clone used for detection at our center is 22C3. No prior anti-cancer treatment.\n4. Function levels of major organs must meet the required criteria\n5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.\n6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer.\n2. Inflammatory breast cancer.\n3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.\n4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.\n5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.\n6. Serious heart disease or discomfort.\n7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.\n8. Patients with chronic active hepatitis B or active hepatitis C\n9. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.\n10. Individuals with a known history of allergies to the components of this medication regimen.",{"count":56,"type":22},111,[25],"This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+\u002FHER2-low breast cancer with neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab , including the incidences and types of adverse events. The secondary endpoints include event-free survival (EFS), residual cancer burden (RCB), and objective response rate (ORR).",[29],[61,62,63,64,29],"Breast cancer","Toripalimab","Trastuzumab Rezetecan","Neoadjuvant therapy","RECRUITING","2026-01-26",{"date":68,"type":40},"2026-02-03",{"date":70,"type":22},"2026-02-01",{"date":72,"type":22},"2031-02-01",{"name":74,"class":47},"First Affiliated Hospital of Zhejiang University",5,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100617373","phase-2-chemotherapy-with-or-without-adebrelimab-and-t-dxh-as-neoadjuvant-therapy-for-hrher2-low-early-stage-breast-cancer-100617373","NCT07317778","Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+\u002FHER2 Low Early Stage Breast Cancer","Chemotherapy Combine With or Without Adebrelimab and Trastuzumab Rezetecan(SHR-A1811) as Neoadjuvant Therapy for Hormone Receptor Positive\u002FHER2 Low Early Stage Breast Cancer: A Randomized Phase II Trial","Inclusion Criteria:\n\n* ECOG score: 0-1;\n* Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2;\n* HR positive\u002FHER2 low expression(defined as HER2 IHC 1+\u002F2+, FISH negative);\n* Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing;\n* Sufficient organ function\n* Female patients who have not undergone menopause or sterilization, accept for abstain from sexual activity or use an effective contraceptive method during the treatment period and at least 7 months after the last administration of the study medication;\n* Voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer;\n* Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma);\n* Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy;\n* Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures;\n* Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period;\n* Had any cardiac diseases, including: (1) Severe \u002F unstable angina pectoris; (2) Requires drug treatment or has clinically significant arrhythmia; (3) Had a myocardial infarction within 6 months before enrollment; (4) Has symptomatic congestive heart failure with NYHA grade ≥ II; (5) Any other heart diseases judged by the researcher as not suitable for participation in this trial;\n* Known to have had an allergic history to the components of the drug in this protocol; have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation;\n* Had severe comorbidities or other conditions that would interfere with the planned treatment, or any other situation that the researcher considered the patient was not suitable for participation in this study.","75 Years",{"count":85,"type":22},249,[25],"The goal of this clinical trial is to learn if add SHR-A1811 and\u002For Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+\u002FHER2 low early stage breast cancer patients. It will also learn about the safety of these combination regimen. The main questions it aims to answer are:\n\nIs Adebrelimab plus chemotherapy better than T-EC chemotherapy alone in neoadjuvant setting of HR+\u002FHER2-low early stage population? Is SHR-A1811-EC plus Adebrelimab better than T-EC chemotherapy and\u002For Adebrelimab plus chemotherapy\n\nParticipants will:\n\nTake 8 cycles of standard chemotherapy at day1, every 3 weeks cycle(standard care), or take 8 cycles of adebrelimab plus standard chemotherapy at day 1, every 3 weeks cycle(experimental 2), or take 4 cycles of SHR-A1811 and Adebrelimab at day 1, every 3 weeks cycle, then 4 cycles of adebrelimab plus EC chemotherapy at day 1, every 3 weeks cycke(experimental 1).\n\nVisit the clinic once every 6 weeks at neoadjuvant period for tumor assessment. Take surgery after completion of 8 cycles of neoadjuvant therapy and assess the pathological response. Then, visit the clinic once every 12 weeks at first year and then every 6 months for tumor assessment.",[89,29],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[35,91,63,92,93],"adebrelimab","HR+\u002FHER2-low","early stage breast cancer","2025-12-24",{"date":96,"type":40},"2026-01-05",{"date":98,"type":22},"2026-02-15",{"date":100,"type":22},"2033-09-15",{"name":102,"class":47},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":103},"100542235","phase-2-shr-a1811-alone-or-in-combination-with-adebrelimab-as-neoadjuvant-treatment-in-hr-positiveher2-low-breast-cancer-100542235","NCT06340230","SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive\u002FHER2 Low Breast Cancer","A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive\u002FHER2 Low Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 but ≤ 75 years\n2. Histologically confirmed to be HR+\u002FHER2-Low invasive breast cancer\n3. Treatment-naive patients with stage II-III\n4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1\n5. Good level of organ function\n6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits\n\nExclusion Criteria:\n\n1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)\n2. Received any other anti-tumor therapy at the same time\n3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer\n4. Stage IV breast cancer\n5. Not confirmed by histopathology\n6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer\n7. Participated in other drug clinical trials within 4 weeks before enrollment\n8. Known allergic history of the drug components of this protocol\n9. History of immunodeficiency\n10. Clinically significant cardiovascular diseases\n11. Known or suspected interstitial lung disease\n12. Active hepatitis and liver cirrhosis\n13. Known hereditary or acquired bleeding thrombotic tendency\n14. History of neurological or psychiatric disorders",{"count":112,"type":22},93,[25],"This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive\u002FHER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.",[29],[35,117,118,29],"Adebrelimab","Neoadjuvant","2024-12-02",{"date":121,"type":40},"2024-12-04",{"date":123,"type":40},"2024-08-23",{"date":125,"type":22},"2031-02-28",{"name":127,"class":47},"Shengjing Hospital"]