[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07483307":3,"trial-entities:NCT07483307":149,"trial-summary:NCT07483307":153},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":23,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":15,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":62,"locations":65,"central_contacts":134,"overall_officials":141,"references":145,"see_also_links":146},"NCT07483307","26-095","A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer","Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study","RECRUITING","2030-03-13","2026-06","2026-06-04","2026-03-13","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at the edges of tissue removed during surgery (positive margins).",[18,19,20,21,22],"Breast Cancer","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","ER+ Breast Cancer","Lobular Breast Carcinoma",[18,19,20,21,5,13,24],"Lobular Breast Cancer","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},176,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Neoadjuvant endocrine therapy","The endocrine therapy used for the NET in this study will be anastrozole, letrozole, exemestane, or tamoxifen.",[38],"Participants with ER+\u002FHER2- Breast Cancer",[40],"NET",[42],{"measure":43,"description":44,"timeFrame":45},"Rate of positive surgical margins after breast cancer surgery","To prospectively evaluate rates of positive surgical margins after initial breast cancer surgery\u002FBCS among postmenopausal women with cT2-3 N0-1 ER+\u002FHER2- ILC who have undergone a course of NET.","up to 3 months",[],"FEMALE","50 Years",false,{"inclusion":51,"exclusion":55,"raw_text":61},[52,53,54],"Written informed consent by participant or legally authorized representative","Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.","Tumors of the ER+\u002FHER2- subtype, defined as:",[56,57,58,59,60],"Patients with prior ipsilateral breast cancer.","Patients with advanced regional disease (cN2\u002FcN3) or stage 4 disease.","Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.","Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).","Patients with gadolinium allergy, precluding the use of breast MRI.","Inclusion Criteria:\n\n* Written informed consent by participant or legally authorized representative\n* Postmenopausal women aged ≥50 years with biopsy-proven cT2-T3 N0-1 ILC who opt to undergo and are medically fit to undergo BCS at enrollment.\n* Tumors of the ER+\u002FHER2- subtype, defined as:\n\n  1. ER+: Positive for ER staining as indicated by ≥10% immunoreactive tumor nuclei.\n  2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay.\n\nExclusion Criteria:\n\n* Patients with prior ipsilateral breast cancer.\n* Patients with advanced regional disease (cN2\u002FcN3) or stage 4 disease.\n* Patients who would benefit from neoadjuvant chemotherapy, per the treating medical oncologist.\n* Patients who are not candidates for definitive breast surgery (inoperable or stage 4 disease).\n* Patients with gadolinium allergy, precluding the use of breast MRI.",[63,64],"ADULT","OLDER_ADULT",[66,80,89,98,108,117,125],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":77},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[73],{"name":74,"role":75,"phone":76},"Anita Mamtani, MD","CONTACT","646-888-6864",{"lat":78,"lon":79},40.70621,-74.54932,{"facility":81,"status":8,"city":82,"state":69,"zip":83,"country":71,"contacts":84,"geoPoint":86},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[85],{"name":74,"role":75,"phone":76},{"lat":87,"lon":88},40.39428,-74.11709,{"facility":90,"status":8,"city":91,"state":69,"zip":92,"country":71,"contacts":93,"geoPoint":95},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[94],{"name":74,"role":75,"phone":76},{"lat":96,"lon":97},41.04676,-74.02292,{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":71,"contacts":103,"geoPoint":105},"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",[104],{"name":74,"role":75,"phone":76},{"lat":106,"lon":107},40.84288,-73.29289,{"facility":109,"status":8,"city":110,"state":101,"zip":111,"country":71,"contacts":112,"geoPoint":114},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[113],{"name":74,"role":75,"phone":76},{"lat":115,"lon":116},40.96899,-73.71263,{"facility":118,"status":8,"city":101,"state":101,"zip":119,"country":71,"contacts":120,"geoPoint":122},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[121],{"name":74,"role":75,"phone":76},{"lat":123,"lon":124},40.71427,-74.00597,{"facility":126,"status":8,"city":127,"state":101,"zip":128,"country":71,"contacts":129,"geoPoint":131},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",[130],{"name":74,"role":75,"phone":76},{"lat":132,"lon":133},40.70038,-73.59291,[135,137],{"name":74,"role":75,"phone":76,"email":136},"mamtana1@mskcc.org",{"name":138,"role":75,"phone":139,"email":140},"George Plitas, MD","646-888-5368","PlitasG@mskcc.org",[142],{"name":143,"affiliation":13,"role":144},"Anita SKCCSC(P Mamtani, MD","PRINCIPAL_INVESTIGATOR",[],[147],{"label":13,"url":148},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":150,"biomarkers":152},[151],"Invasive Breast Lobular Carcinoma",[],{"nct_id":4,"found":154,"summary":155,"prompt_version":165},true,{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 176 participants.","completed","Study of Endocrine Therapy for Lobular Breast Cancer","This study is looking at how well endocrine therapy, given before surgery, works for postmenopausal women with a specific type of breast cancer called invasive lobular carcinoma (ILC). The endocrine therapies being studied are anastrozole, letrozole, exemestane, or tamoxifen. You may be able to join if you are a woman aged 50 or older, have ILC that is HER2-negative and ER-positive (meaning your cancer cells have certain characteristics), and are planning to have breast-conserving surgery. The main goal is to see if this treatment reduces the chance of having cancer cells at the edges of the tissue removed during surgery. The study aims to enroll 176 participants, but its current status is unclear.","The primary endpoint, the rate of positive surgical margins, is measured at up to 3 months.",113,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]