[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634545":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":11,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":11,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":56,"whyStopped":11,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Giredestrant","EXPERIMENTAL",null,[13],"Drug: Giredestrant",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Participants will receive giredestrant at a dose of 30 mg orally once daily on Days 1-28 of each 28-day cycle for up to 4.5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).",[9],[20],{"name":21,"affiliation":5,"role":22},"Clinical Trials","STUDY_DIRECTOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Reference Study ID Number: GO46747 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":30,"role":26,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100634545","phase-3-a-study-evaluating-adherence-tolerability-and-patient-reported-outcomes-of-giredestrant-in-participants-with-erher2--early-breast-cancer-who-are-intolerant-to-adjuvant-aromatase-inhibitor-therapy-novera-breast-cancer-100634545",false,"NCT07541079","A Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes of Giredestrant in Participants With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy (novERA Breast Cancer)","A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+\u002FHER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy","Inclusion Criteria:\n\n* Considered appropriate for treatment with endocrine therapy (ET)\n* Histologically confirmed diagnosis of ER+\u002FHER2-, Stage I-III (low-\u002Fmedium-\u002Fhigh-risk) early breast cancer (eBC)\n* Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive\n* Documented HER2- tumor according to ASCO\u002FCAP\n* Postmenopausal females at the time of signing the Informed Consent Form\n* Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months\n* Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent\n* Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment\n* Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance\n* Participant and investigator planning the first switch from an AI\n* Has completed the following: (neo)adjuvant chemotherapy (if administered), definitive surgery of primary breast tumor(s) and\u002For axillary lymph nodes dissection (ALND) and\u002For sentinel lymph node biopsy (SLNB) and\u002For radiotherapy\n* Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1\n\nExclusion Criteria:\n\n* Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease\n* Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)\n* Have active cardiac disease or history of cardiac dysfunction\n* Have clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis\n* Treatment with strong CYP3A inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment\n* Have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study","FEMALE","18 Years",{"count":43,"type":44},300,"ESTIMATED","INTERVENTIONAL",[47],"PHASE3","The purpose of this study is to understand treatment adherence and patient-reported outcomes of switching to giredestrant due to prior aromatase inhibitor (AI) intolerance. Giredestrant will be administered as adjuvant endocrine therapy for participants with low-, medium-, and high-risk, Stage I-III, histologically confirmed, estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), early breast cancer (eBC), as defined by the investigator. Participants will enroll if considered to be intolerant to a prior adjuvant AI therapy.",[50],"Early Breast Cancer",[52,53,54,55],"Estrogen receptor positive","ER+","Human epidermal growth factor receptor 2 negative","HER2-","NOT_YET_RECRUITING","2026-06-18",{"date":59,"type":60},"2026-06-23","ACTUAL",{"date":62,"type":44},"2026-06-30",{"date":64,"type":44},"2034-06-30",{"name":5,"class":6}]