[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07541079":3,"trial-entities:NCT07541079":123,"trial-summary:NCT07541079":127},{"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":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":38,"secondary_outcomes":45,"sex":68,"minimum_age":69,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":70,"std_ages":93,"locations":96,"central_contacts":106,"overall_officials":114,"references":118,"see_also_links":119},"NCT07541079","GO46747","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","RECRUITING","2034-06-30","2026-07","2026-07-20","2026-08-15","Genentech, Inc.","INDUSTRY",false,"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.",null,[19],"Early Breast Cancer",[21,22,23,24],"Estrogen receptor positive","ER+","Human epidermal growth factor receptor 2 negative","HER2-","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},300,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DRUG","Giredestrant","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).",[35],[39,42],{"measure":40,"timeFrame":41},"Incidence of Participants Who Have Discontinued Giredestrant for Any Reason at 12 Months","At 12 months",{"measure":43,"timeFrame":44},"Incidence and Severity of Adverse Events, with Severity Determined According to the National Cancer Institute Common Terminology Criteria of Adverse Events, version 6.0 (NCI CTCAE v6.0)","From baseline until 28 days after the final dose of study drug (up to 4 years, 7 months)",[46,50,53,56,59,62,65],{"measure":47,"description":48,"timeFrame":49},"Percentage of Participants Achieving an Improvement in Individual Endocrine Therapy-specific Symptoms at 6 and 12 Months, Using the FACT-ES Questionnaire","An improvement in individual endocrine therapy-specific symptoms (joint pain, hot flashes, vaginal dryness, and sexual dysfunction) is defined as ≥1-point\u002Fshift increase from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire items.","Baseline, 6 and 12 months",{"measure":51,"description":52,"timeFrame":49},"Percentage of Participants Categorized as Improved, Stable, or Worsening in Endocrine Therapy-specific Symptom Burden at 6 and 12 Months, Using the FACT-ES Questionnaire","Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire Additional Concerns subscale score using a minimal important difference (MID) threshold of ±3 points.",{"measure":54,"description":55,"timeFrame":49},"Percentage of Participants Categorized as Improved, Stable, or Worsened in Pain-related Burden at 6 and 12 Months, Using the BPI-SF Questionnaire","Categories are defined by a change from baseline in the Brief Pain Inventory-Short Form (BPI-SF) Pain Severity composite score (minimal important difference \\[MID\\] of ±2 points) and the BPI-SF Pain Interference composite score (MID of ±1 point).",{"measure":57,"description":58,"timeFrame":49},"Percentage of Participants Achieving an Improvement in Global Treatment Bother at 6 and 12 Months, Using the FACT-ES Questionnaire's GP5 Item","An improvement is defined as a ≥1-point increase from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) GP5 item ('I am bothered by side-effects of treatment').",{"measure":60,"description":61,"timeFrame":49},"Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Physical Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire","Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Physical Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points.",{"measure":63,"description":64,"timeFrame":49},"Percentage of Participants Categorized as Improved, Stable, or Worsened in Domain-specific Functional Well-Being at 6 and 12 Months, Using the FACT-ES Questionnaire","Categories are defined by a change from baseline in the respective Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Functional Well-Being subscale scores using a minimal important difference (MID) threshold of ±2 points.",{"measure":66,"description":67,"timeFrame":49},"Percentage of Participants Categorized as Improved, Stable, or Worsened in Global Health-Related Quality of Life (HRQoL) at 6 and 12 Months, Using the FACT-ES Questionnaire","Categories are defined by a change from baseline in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Total Score using a minimal important difference (MID) threshold of ±7 points.","FEMALE","18 Years",{"inclusion":71,"exclusion":84,"raw_text":92},[72,73,74,75,76,77,78,79,80,81,82,83],"Considered appropriate for treatment with endocrine therapy (ET)","Histologically confirmed diagnosis of ER+\u002FHER2-, Stage I-III (low-\u002Fmedium-\u002Fhigh-risk) early breast cancer (eBC)","Documented ER+ tumor according to American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP), defined as ≥1% of tumor cells stained positive","Documented HER2- tumor according to ASCO\u002FCAP","Postmenopausal females at the time of signing the Informed Consent Form","Documented use of a prior adjuvant aromatase inhibitor (AI) (i.e., anastrozole, exemestane, or letrozole) for a total of ≥6 months","Documented use of an adjuvant AI (i.e., anastrozole, exemestane, or letrozole) for the consecutive ≥3 months immediately prior to consent","Participant and investigator agree that current symptoms on AI are intolerable and warrant a switch in therapy to attempt sustained treatment","Documented Grade 2 or 3 adverse events, per NCI CTCAE v6.0, determined by the investigator to be associated with AI therapy's intolerance","Participant and investigator planning the first switch from an AI","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","Eastern Cooperative Oncology Group Performance (ECOG) Performance Status 0 or 1",[85,86,87,88,89,90,91],"Participation within 6 months before enrollment in any other clinical study involving an investigational adjuvant treatment including anti-cancer agents","Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory connective tissue disease","Any prior fulvestrant or any oral selective estrogen receptor degraders (SERDs)","Have active cardiac disease or history of cardiac dysfunction","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","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","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","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",[94,95],"ADULT","OLDER_ADULT",[97],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"geoPoint":103},"Orange Coast Medical Center","Fountain Valley","California","92708-6728","United States",{"lat":104,"lon":105},33.70918,-117.95367,[107,112],{"name":108,"role":109,"phone":110,"email":111},"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":113,"role":109},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[115],{"name":116,"affiliation":13,"role":117},"Clinical Trials","STUDY_DIRECTOR",[],[120],{"label":121,"url":122},"Please use this form to submit your questions for a faster response: https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.","https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"nct_id":4,"conditions":124,"biomarkers":126},[125],"Breast Carcinoma",[],{"nct_id":4,"found":128,"summary":129,"prompt_version":139},true,{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is an interventional study planning to enroll 300 participants. The phase of the study is not specified.","completed","Giredestrant for Early Breast Cancer After AI Intolerance","This study is looking at giredestrant, a medication for early breast cancer, in women who have estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer and could not tolerate previous aromatase inhibitor (AI) therapy. The study aims to understand how well patients stick to their giredestrant treatment and how they feel while taking it. You would take giredestrant daily for up to 4.5 years. To join, you must have ER+ and HER2- early breast cancer and have found previous AI therapy difficult to tolerate. The main goals are to see how many people stop taking giredestrant within 12 months and to track any side effects.","Side effects will be monitored from the start of the study until 28 days after your last dose of giredestrant, which could be up to 4 years and 7 months.",104,"You would take giredestrant orally once daily for up to 4.5 years, or until your disease returns or side effects become too much.","Not stated in the trial record.",[35],"v2"]