[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605092":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":87,"collaborators":40,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":40,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":40,"enrollmentInfo":98,"targetDuration":40,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":40,"overallStatus":70,"whyStopped":40,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Michigan Rogel Cancer Center","OTHER",[8,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (leuprolide)","EXPERIMENTAL","Leuprolide 3.75 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.",[13,14,15,16],"Procedure: Biospecimen Collection","Other: Electronic Health Record Review","Drug: Leuprolide","Other: Questionnaire Administration",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm II (leuprolide)","Leuprolide 7.5 mg q4weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Arm III (goserelin)","Goserelin 3.6 mg q4 weeks. Cycles repeat every 28 days for up to 24 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study.",[13,14,25,16],"Drug: Goserelin",[27,36,41,48,54],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,18,22],[33,34,35],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Electronic Health Record Review","Ancillary studies",[9,18,22],null,{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Goserelin","Given SC",[22],[47],"ICI-118630",{"type":42,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Leuprolide","Given IM",[9,18],[53],"Leuprorelin",{"type":6,"name":55,"description":38,"armGroupLabels":56,"otherNames":40},"Questionnaire Administration",[9,18,22],[58],{"name":59,"affiliation":5,"role":60},"Norah L Henry","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":40,"email":66},"Cancer AnswerLine","CONTACT","1-800-865-1125","CancerAnswerLine@med.umich.edu",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"University of Michigan Comprehensive Cancer Center","RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":77,"coordinates":78},"Point",[79,80],-83.74088,42.27756,{"lat":80,"lon":79},[83,85],{"name":63,"role":64,"phone":84,"phoneExt":40,"email":66},"800-865-1125",{"name":86,"role":60,"phone":40,"phoneExt":40,"email":40},"Norah L. Henry",{"type":88,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100605092","phase-2-leuprolide-and-goserelin-for-ovarian-function-suppression-in-pre--or-peri-menopausal-women-with-breast-cancer-ofs-trial-100605092",false,"NCT07158021","Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial","Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)","Inclusion Criteria:\n\n* Female subject aged ≥ 18 years\n* Pre- or peri-menopausal patient, who had (1) menses either within the 12 months prior to or since breast cancer diagnosis or (2) estradiol concentration above the postmenopausal range per institutional laboratory guidance either within the 12 months prior to or since breast cancer diagnosis.\n* Planning to take GnRHa therapy in combination with oral endocrine therapy (tamoxifen, anastrozole, exemestane, or letrozole) for adjuvant treatment of stage 1-3 breast cancer or for treatment of metastatic breast cancer. Prior treatment with GnRHa therapy for treatment of non-oncologic conditions or during chemotherapy is permitted.\n* Not planning bilateral salpingo-oophorectomy during the 6-month study duration\n* Completion of chemotherapy, if given. Concurrent use of trastuzumab, pertuzumab, bisphosphonate therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor therapy, cyclin D kinase 4\u002F6 (CDK4\u002F6) inhibitor, and\u002For phosphoinositide 3-kinase (PI3K) inhibitor therapy is permitted\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines\n\nExclusion Criteria:\n\n* Prior bilateral salpingo-oophorectomy\n* Known to be pregnant or breastfeeding (negative pregnancy test will be confirmed prior to study treatment initiation)\n* Concomitant use of systemic or transdermal estrogen products\n* Known allergy or hypersensitivity to goserelin or leuprolide, or any of the excipients in the medications\n* Unable to take oral medications\n* Any medical condition that would interfere with the absorption of endocrine therapy. Prior gastric bypass is permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment, in the opinion of the treating investigator, has the potential to interfere with the safety or efficacy assessment of the investigational regimen","FEMALE","18 Years",{"count":99,"type":100},75,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","This phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and\u002For effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.",[106,107,108,109,110],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Metastatic Breast Carcinoma","2026-06-18",{"date":113,"type":114},"2026-06-23","ACTUAL",{"date":116,"type":114},"2026-01-22",{"date":118,"type":100},"2028-01-01",{"name":5,"class":6},1]