[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endocrine-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endocrine-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,75,97,125,150],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627064","evaluation-of-adherence-to-cell-cycle-inhibitors-used-as-adjuvant-therapy-in-patients-with-localized-breast-cancer-at-high-risk-of-recurrence-100627064",false,"NCT07443774","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence","AdheRA","Inclusion Criteria\n\n* Male or female patients aged ≥18 years.\n* Operable invasive breast carcinoma of no special type, hormone receptor-positive \u002F HER2-negative (estrogen receptor expression \\>10% with or without progesterone receptor expression \\>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified).\n* M0 disease according to the TNM 2018 classification.\n* Having undergone curative surgery of the primary breast tumor.\n* Having received adjuvant radiotherapy, if indicated.\n* Indication for combined adjuvant endocrine therapy and iCDK4\u002F6 therapy validated during a multidisciplinary tumor board meeting.\n* Initiation of adjuvant endocrine therapy combined with a CDK4\u002F6 inhibitor between June 2023 and June 2028.\n* No objection to participation in the study.\n* Affiliation with the national health insurance system.\n\nNon-Inclusion Criteria\n\n* Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition.\n* Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment","ALL","18 Years",{"count":20,"type":21},81,"ESTIMATED","OBSERVATIONAL","Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1). Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors (AIs), is an effective pharmacological treatment for improving the prognosis of HR+ breast cancer, reducing the risk of recurrence by up to 50% (2-3-4-6). Despite its proven prognostic benefit, the full potential of endocrine therapy is not realized due to patient non-adherence (i.e., failure to comply with prescribed treatment). Adjuvant endocrine therapy is generally prescribed for a duration of 5 to 10 years. However, up to 40% of patients discontinue treatment prematurely, and 30% take the medication less frequently than prescribed. Poor adherence and low treatment persistence carry a substantial mortality burden: non-adherence is associated with a 49% increase in all-cause mortality. A retrospective analysis of a large database including more than 8,700 patients showed a 10-year survival rate of 80.7% among women who continued treatment, compared with 73.6% among those who discontinued adjuvant therapy prematurely (p \\\u003C 0.001). Among patients who continued treatment, the survival rate was 82% in those who were fully adherent, versus 78% in those who were only partially adherent (7-16).\n\nThe literature has documented a wide range of risk factors associated with non-adherence to or discontinuation of long-term adjuvant endocrine therapy. Treatment-related adverse effects, including hot flashes, joint stiffness, and sexual dysfunction, are common and may lead to treatment discontinuation. Fear of side effects may also prevent some patients from initiating or maintaining endocrine therapy. Others may not be fully convinced of the necessity of adjuvant endocrine therapy, particularly in the absence of overt signs of cancer. In addition, supportive care required to manage side effects is often inadequately reimbursed, making low income-combined with broader socioeconomic factors-a potential barrier to optimal adherence. Some patients may also experience difficulties remembering to take their medication regularly. The relative importance and contribution of these factors to non-adherence may evolve over time. Other factors may also play a role, including sociodemographic characteristics (low income, living alone, or unemployment).\n\nNevertheless, a residual risk of recurrence persists after five years of well-conducted standard endocrine therapy, extending up to two decades after diagnosis, particularly in patients with early-stage breast cancer stages II and III. In this higher-risk population, two phase III trials, monarchE and NATALEE, have recently evaluated the addition of a cell cycle inhibitor (CDK4\u002F6 inhibitor) to standard adjuvant endocrine therapy and reported positive results with a reduction in the risk of relapse.\n\nIn the NATALEE trial, quality of life was assessed in all patients in the ribociclib plus aromatase inhibitor group (n = 2,549) versus the aromatase inhibitor alone group (n = 2,552). Mean scores did not differ significantly from baseline for any of the analyzed domains. Similarly, no significant change from baseline was observed in either treatment group.\n\nHowever, it is important to note that 33.8% of patients discontinued ribociclib and 20% discontinued both endocrine therapy and ribociclib in the NATALEE trial, which is consistent with data from the literature.\n\nIn the monarchE trial, 16.6% of patients discontinued abemaciclib, and 6% discontinued both abemaciclib and endocrine therapy, while only 0.8% discontinued endocrine therapy in the control group. These findings are not consistent with previously published data.\n\nTo our knowledge, no real-world study has evaluated CDK4\u002F6 inhibitors in combination with endocrine therapy in the adjuvant treatment of HR+\u002FHER2-negative breast cancer.\n\nAdheRA is a prospective multicenter cohort study of patients with early-stage HR+\u002FHER2-negative breast cancer at high risk of recurrence, eligible for a combination of endocrine therapy and a CDK4\u002F6 inhibitor such as abemaciclib or ribociclib in the adjuvant setting, aiming to assess treatment adherence and the reasons for non-adherence.",[25,26,27,28,29,30],"ER+ Breast Cancer","Breast Cancer","Early Breast Cancer","Endocrine Therapy","Abemaciclib","Ribociclib",[32,33,34,35],"early breast cancer","celle cycle inhibitors","endocrine therapy","adjuvant setting","NOT_YET_RECRUITING","2026-02-26",{"date":39,"type":40},"2026-03-02","ACTUAL",{"date":42,"type":21},"2026-04-01",{"date":44,"type":21},"2031-12",{"name":46,"class":47},"University Hospital, Grenoble","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100607583","phase-3-adjuvant-abemaciclib-for-locoregional-recurrence-of-hr-positive-her2-negative-breast-cancer-jcog2313-aura-100607583","NCT07190443","Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)","Randomized Phase III Trial for Evaluating the Efficacy of Adjuvant Abemaciclib in Patients With Locoregional Recurrence of Hormone Receptor-positive, HER2-negative Breast Cancer. JCOG2313, AURA Trial.","AURA","Inclusion criteria:\n\n1. The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following:\n\n   (i) Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence\n2. At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following:\n\n   (i) Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive).\n\n   (ii) Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative.\n\n   ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.\n3. No prior diagnosis of distant metastasis of breast cancer.\n4. Imaging assessment before registration confirms:\n\n   No lymph nodes ≥10 mm in short axis No evidence of distant metastasis\n5. Age ≥18 years at the time of registration.\n6. ECOG Performance Status of 0 or 1.\n7. Chemotherapy for LRR is allowed prior to enrollment.\n8. The patient does not have bilateral breast cancer.\n9. No prior history of treatment with CDK4\u002F6 inhibitors.\n10. Written informed consent has been obtained for participation in this clinical trial.\n\nExclusion Criteria:\n\n1. Presence of active double cancer (synchronous malignancy requiring treatment).\n2. Ongoing infectious disease requiring systemic therapy.\n3. Fever ≥38.0°C at the time of registration.\n4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.\n5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.\n6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg\u002Fday of prednisolone or other immunosuppressive agents.\n7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.\n8. Uncontrolled hypertension.\n9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.\n10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)\n11. Positive for HIV antibodies (HIV testing is not mandatory.)\n12. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.",{"count":58,"type":21},290,"INTERVENTIONAL",[61],"PHASE3","The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR).\n\nAlthough HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely.\n\nAbemaciclib, a CDK4\u002F6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR.\n\nEligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution.\n\nAdditionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response.\n\nThe JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.",[26,64,29,28],"Locoregional Recurrence","RECRUITING","2025-09-24",{"date":68,"type":40},"2025-09-29",{"date":70,"type":40},"2025-02-07",{"date":72,"type":21},"2035-02-06",{"name":74,"class":47},"Japanese Foundation for Cancer Research",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100518649","real-world-study-on-cdk46-inhibitors-combined-with-endocrine-therapy-and-subsequent-treatment-in-hrher2--mbc-100518649","NCT06033287","Real-World Study on CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- MBC.","Observational Real-World Study on the Efficacy, Safety, and Biomarker Exploration of CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- Metastatic Breast Cancer.","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  * Age ≥ 18 years, postmenopausal or pre\u002Fperimenopausal females, or male patients. Female patients must meet one of the following criteria:\n\n    1. Prior bilateral oophorectomy or age ≥ 60 years.\n    2. Age \\\u003C 60 with natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without any other pathological or physiological reasons), and estradiol (E2) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal range.\n    3. Pre\u002Fperimenopausal females may also be eligible but must be willing to receive LHRH agonist during the study.\n  * Pathologically confirmed HR-positive male\u002Ffemale breast cancer patients with evidence of localized recurrence or metastasis, who are not suitable for curative surgery or radiation therapy:\n\nER-positive and\u002For PR-positive defined as the proportion of positively stained tumor cells ≥ 1% of all tumor cells (as confirmed by the investigators at the participating center).\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* No prior systemic treatment or currently receiving CDK4\u002F6 inhibitors as first-line treatment for advanced disease.\n* Reproductive-age females must have a negative serum pregnancy test within 28 days before enrollment and male\u002Ffemale patients must be willing to use a medically approved highly effective contraceptive measure during the study period and up to 1 year after the last dose of investigational drug.\n* Non-pregnant or non-lactating females.\n* Not concurrently participating in any other ongoing study.\n* Patient or legally authorized representative has provided informed consent and is willing and able to comply with the planned visits, study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* 1\\. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled hypertension, active bleeding disorders, active infections including hepatitis B, hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney impairment, which, in the investigator's opinion, would greatly alter the risk\u002Fbenefit balance.\n* Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior treatment at the start of CDK4\u002F6 inhibitor therapy.\n* Known history of allergy to CDK4\u002F6 inhibitors, excipients, or drugs with a similar chemical structure or class as CDK4\u002F6 inhibitors.\n* Patients deemed unsuitable for enrollment by the investigator.",{"count":83,"type":21},300,"Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4\u002F6i Progression in the Real World has significant implications. This study is an observational, real-world study. It plans to include over 300 eligible HR+\u002FHER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4\u002F6 inhibitors. This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4\u002F6 inhibitors combined with endocrine therapy, based on clinical guideline consensus. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4\u002F6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be chosen by the physician, and the efficacy and safety of subsequent treatment will be evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some patients.",[26,28,86,87],"CDK4\u002F6 Inhibitors","Subsequent Treatment","2025-07-08",{"date":90,"type":40},"2025-07-11",{"date":92,"type":40},"2023-01-01",{"date":94,"type":21},"2025-12-31",{"name":96,"class":47},"Hunan Cancer Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":104,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":48},"100519942","the-benefits-of-continued-use-of-ovarian-function-suppression-after-5-years-100519942","NCT06050109","The Benefits of Continued Use of Ovarian Function Suppression After 5 Years","A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years","Inclusion Criteria:\n\n* Diagnosed with early primary breast cancer\n* Female aged 18-60 years (including 18 year and 60 year)\n* Hormone receptor (HR) positive HER2 negative\n* Receive 5 years of OFS treatment\n* ECOG score 0-1\n* Voluntarily join this study and sign the informed consent form;\n* The researcher believes that it can benefit.\n\nExclusion Criteria:\n\n* The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years\n* Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision\n* Invasive metastases with known obvious symptoms\n* Invasive metastases with known obvious symptoms\n* Doctors think it is not suitable for inclusion","FEMALE","60 Years",{"count":107,"type":21},1200,"To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.\n\nThis study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.",[110,28],"Breast Cancer Female",[112,113,114,32,115],"ovarian function suppression","Hormone receptor (HR) positive","HER2 negative","prolonged therapy","2025-03-14",{"date":118,"type":40},"2025-03-17",{"date":120,"type":40},"2023-09-01",{"date":122,"type":21},"2028-09-01",{"name":124,"class":47},"Hongmei Zheng, PhD",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":59,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":48},"100565497","ai-based-skeleton-recognition-system-for-rehabilitation-exercise-in-breast-cancer-survivors-a-randomized-controlled-trial-100565497","NCT06642948","AI-based Skeleton Recognition System for Rehabilitation Exercise in Breast Cancer Survivors: A Randomized Controlled Trial","Evaluating the Efficacy of Structured Exercise Interventions in Alleviating Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors: A Randomized Controlled Trial","AiRE-MS","Inclusion Criteria:\n\n* 1\\. Pathologically confirmed hormone receptor-positive breast cancer (stage I, II, III).\n\n  2\\. Initiation of treatment with aromatase inhibitors (e.g., anastrozole, letrozole, exemestane).\n\n  3\\. Postmenopausal women, including those with surgically induced menopause. 4. Clear consciousness, no cognitive or communication impairments, and able to comply with the intervention.\n\n  5\\. Informed consent obtained, with voluntary participation in the study. 6. Bone and joint symptoms with a Brief Pain Inventory (BPI) score of ≥3, or presence of at least one of the following risk factors: elevated bone turnover markers, reduced vitamin D levels, increased inflammatory cytokines, elevated C-reactive protein, or elevated rheumatoid factor.\n\n  7\\. Not participating in any physical therapy or exercise-based interventions that may interfere with this study.\n\nExclusion Criteria:\n\n\\- 1. Recurrence of breast cancer or distant metastasis. 2. Presence of other malignancies. 3. Diagnosed rheumatoid arthritis, bone and joint trauma, or other severe bone and joint diseases.\n\n4\\. Bone mineral density T-score \\\u003C-2.5. 5. Presence of absolute contraindications to exercise.",{"count":134,"type":21},80,[136],"NA","This study aims to develop and evaluate an artificial intelligence (AI)-based skeletal recognition system designed to support real-time, interactive rehabilitation exercise (RE programs. The goal is to mitigate musculoskeletal symptoms associated with endocrine therapy in breast cancer survivors.Endocrine therapy remains a cornerstone in the treatment of hormone receptor-positive breast cancer, typically extending over 5 to 10 years. While the therapeutic benefits of endocrine therapy are well established, agents such as aromatase inhibitors frequently induce musculoskeletal symptoms (MS), including joint pain, stiffness (particularly morning stiffness), carpal tunnel syndrome, tenosynovitis, myalgia, and muscle weakness. These symptoms, which may be continuous or intermittent, can affect both central (spine, hips, shoulders) and peripheral joints (elbows, wrists, knees, feet), severely compromising patients' quality of life (QoL). Although physical exercise has been demonstrated to alleviate these symptoms, adherence to adequate exercise regimens remains suboptimal among patients. Furthermore, there is no consensus on the optimal type, duration, or intensity of exercise interventions, and standardized protocols are lacking. Recognizing exercise as a long-term behavior, we are developing a home-based, AI-assisted rehabilitation program tailored to the specific needs of patients undergoing endocrine therapy.",[139,26,28,140],"Musculoskeletal Symptoms","Aromatase Inhibitors","2024-10-14",{"date":143,"type":40},"2024-10-15",{"date":145,"type":21},"2024-10-20",{"date":147,"type":21},"2025-01-01",{"name":149,"class":47},"Fudan University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":104,"minAge":4,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":48},"100462701","assessment-of-brain-cognitive-impairment-in-breast-cancer-100462701","NCT05305092","Assessment of Brain Cognitive Impairment in Breast Cancer","Integrated PET\u002FMRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy","Inclusion Criteria:\n\n* Patients with primary stage I-II breast cancer.\n* Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).\n* No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).\n* Eastern Cooperative Oncology Group score of 0-1 points.\n* Can understand and complete various scales.\n* Right handedness.\n* Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.\n* Sign the informed consent and voluntarily participate in this clinical observation.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.\n* Current or former epilepsy, dementia, or learning disabilities.\n* Past psychiatric history.\n* Past history of malignancy.\n* MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.",true,{"count":159,"type":21},90,"To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET\u002FMRI technology combined with psychobehavioral technology.",[26,162,28],"Chemo-brain",[164,165,166,167],"CRCI","psycho-behavioral technology","Integrated PET\u002FMRI technology","Biomarkers","2022-07-12",{"date":170,"type":40},"2022-07-13",{"date":172,"type":40},"2022-05-31",{"date":174,"type":21},"2027-05-30",{"name":176,"class":47},"Tang-Du Hospital"]