[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brest-cancer-er-and-her2-negative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brest-cancer-er-and-her2-negative":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100659484","phase-2-de-escalation-of-aromatase-inhibitor-therapy-a-randomized-phase-ii-study-of-de-escalated-letrozole-in-hormone-receptor-positive-early-breast-cancer-100659484",false,"NCT07866430","De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer","De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer (DELTA Trial)","DELTA","Inclusion Criteria:\n\n* Participants must have histologically confirmed breast cancer, clinical stage I-III as per the AJCC 8th edition (Anatomic Prognostic Staging).\n\nTumors must be estrogen receptor-positive (ER expression ≥ 10%) and HER2 negative (IHC 0-1+, or IHC 2+ with negative FISH). Tumors can be progesterone receptor positive or negative.\n\nParticipants must be planned to undergo surgery upfront.\n\nAge ≥18 years.\n\nParticipants must be postmenopausal female.\n\nECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n\nParticipants must have an adequate organ and marrow function as defined below:\n\nabsolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN\n\nParticipants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nAbility to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nParticipants must not have received prior therapy for current breast cancer.\n\nParticipants must be postmenopausal defined as any of the following:\n\n* Age ≥60 years\n* Age \\\u003C60 years with ≥12 months of spontaneous amenorrhea without chemotherapy, endocrine therapy, ovarian suppression, pregnancy, or lactation\n* Prior bilateral oophorectomy\n* Age \\\u003C60 years with hysterectomy and laboratory values in the postmenopausal range (elevated FSH and low estradiol)\n\nExclusion Criteria:\n\nParticipants who are candidates for neoadjuvant therapy.\n\nParticipants who are receiving any other investigation agents.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to letrozole.\n\nParticipants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n\nMale participants at birth\n\nHistory of severe osteoporosis (T score \\\u003C -4 either spine or hip), or presence of vertebral fracture.","FEMALE","18 Years","59 Years",{"count":21,"type":22},144,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This study is a randomized, open-label, phase II trial designed to evaluate whether alternate-day dosing of letrozole preserves antiproliferative activity compared with standard daily dosing in postmenopausal women with estrogen receptor-positive, HER2-negative breast cancer.",[28],"Brest Cancer ER+ and HER2 Negative",[30,31],"Biomarkers","Patient Reported Outcomes","NOT_YET_RECRUITING","2026-10-05",{"date":35,"type":36},"2026-10-08","ACTUAL",{"date":38,"type":22},"2026-09",{"date":40,"type":22},"2032-12",{"name":42,"class":43},"Montefiore Medical Center","OTHER"]