[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esr1-gene-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esr1-gene-mutation":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,89,114,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100610025","phase-2-phii-randomized-capecitabine--elacestrant-vs-capecitabine-alone-in-er-breast-cancer-capela-100610025",false,"NCT07222215","PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)","CAPELA","Inclusion Criteria:\n\n* Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer. ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved setting. ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed. Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.\n* Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status. In patients without ESR1 mutation, this result must be from within 3 months.\n\n  * ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G\n  * TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory\n* Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \\\u003C18 years of age are excluded from this study\n* Women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery\n* Must have measurable or evaluable disease by RECIST 1.1. Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy\n* Unrestricted number of prior endocrine therapies (with or without targeted treatment) are allowed in the advanced disease setting. If a patient recurred on or within one year of adjuvant endocrine therapy, it would be counted as one line of treatment.\n* Prior CDK4\u002F6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4\u002F6 inhibitor is contraindicated (CDK4\u002F6 inhibitor in combination with endocrine treatment is considered as one line of endocrine treatment).\n* Participants must have remained on a prior endocrine treatment alone or in combination with a CDK4\u002F6 inhibitor in the metastatic setting without progression for at least 6 months prior to study entry. This regimen does not need to be the most recent regimen prior to study entry. If patients have progressed on adjuvant endocrine treatment and have not received treatment in the metastatic setting, they must have progressed after at least two years of adjuvant endocrine treatments.\n* Prior alpelisib with endocrine treatment is allowed (considered as a line of endocrine treatment).\n* Prior everolimus with endocrine treatment is allowed (considered a line of endocrine treatment).\n* Prior capivasertib with endocrine treatment is allowed (considered a line of endocrine treatment)\n* Prior fulvestrant is permitted. Prior SERM (tamoxifen, lasofoxifene) is permitted. Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted.\n* No prior chemotherapy regimen or ADC is allowed in the metastatic setting.\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing grade \\>1 treatment-related toxicities at study entry and must have completed treatment \\> 14 days prior to registration.\n* ECOG PS 0-1\n* Adequate hematological, liver, and kidney function, as defined below:\n\n  * Absolute neutrophil count \\> 1,500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin \\> 9 g\u002FdL (transfusion is allowed to meet this criterion) Total bilirubin \\\u003C 1.5 x institutional upper limit or normal (ULN) or \\\u003C 3 institutional ULN in the presence of documented Gilbert's syndrome\n  * AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver\n  * Creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2\n* Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of capecitabine.\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:\n\n  * Age \\> 60 years; or\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) and FSH levels are within postmenopausal range; or\n  * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates.\n\nNote: No HIV testing is required at screening unless mandated by local health Authority.\n\n* Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.Hepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before allocation.\n\nHepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\nExclusion Criteria:\n\n* Participants who have had endocrine and\u002For biologic therapy \\\u003C 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.\n* History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.\n* Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of symptoms are allowed if they have received SRS (7-day washout) or WBRT (14-day washout) or asymptomatic untreated brain metastases measuring \\\u003C1cm. Patients with leptomeningeal disease are not eligible. It is unlikely that these patients will benefit from this regimen.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. This could increase risk of toxicity from treatment and potentially decrease adherence to study protocol.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * (1) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. These cases should be discussed with the sponsor-investigator prior to enrollment.\n  * (2) Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. History of prior malignancy puts patients at risk of recurrence from their prior malignancy or progression of a second malignancy which would complicate interpretation of the end points of this trial.\n* Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (dabigatran, digoxin, fexofenadine) or BRCP (rosuvastatin, sulfasalazine). These drugs have potential drug-drug interactions with the study agents.\n* Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced.\n* Medical conditions requiring concomitant administration of medications with a narrow therapeutic window metabolized by CYP3A and for which a dose reduction cannot be considered. See Appendix D for a list of medications that are CYP3A substrates. These drugs have potential drug-drug interactions with the study agents.\n* Female participants lactating or nursing. The safety of these medications in pregnancy or breast feeding patients is unknown.\n\nBoth men and women of all races and ethnic groups are eligible for this trial.","ALL","18 Years",{"count":20,"type":21},297,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4\u002F6 inhibitors, including palbociclib, ribociclib, or abemaciclb.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Capecitabine (a type of fluoropyrimidine antimetabolite)",[27,28,29,30,31,32,33,34,35],"Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","HER2- Breast Cancer","ESR1 Gene Mutation","ER Wildtype","Breast Neoplasms",[37,28,38,39,40,32,41,42],"Advanced Estrogen Receptor-Positive Breast Cancer","Breast cancer","Hormone receptor positive breast cancer","Advanced Human Epidermal Growth Factor Receptor 2 negative breast cancer","ESR1 gene mutation","ER wildtype","RECRUITING","2026-06-10",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2026-01-16",{"date":51,"type":21},"2030-10-01",{"name":53,"class":54},"Kristina A. Fanucci","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100545518","phase-3-elacestrant--everolimus-in-patients-erher2--esr1mut-advanced-breast-cancer-progressing-to-et-and-cdk46i-100545518","NCT06382948","Elacestrant + Everolimus in Patients ER+\u002FHER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4\u002F6i.","A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+\u002FHER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4\u002F6 Inhibitors","ADELA","Inclusion Criteria:\n\nPatients will be included in the study only if they meet ALL of the following criteria:\n\n1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status (defined in continuation) and men must be concurrently receiving a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to study randomization and are planning to continue LHRH agonist treatment during the study.\n\n   Post-menopausal women as defined by any of the following criteria:\n   1. Age ≥ 60 years;\n   2. Age \\\u003C 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and\u002For FSH levels within the laboratory's reference range for post-menopausal females;\n   3. Documented bilateral surgical oophorectomy.\n4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n5. Documentation of ER\\[+\\] (≥10% positive stained cells) and HER2\\[-\\] (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment. ER\\[+\\]\u002FHER2\\[-\\] status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease.\n6. Patients with ESR1 mutational status will be determined before patient randomization using Guardant360 CDx (Guardant Health) test.\n\n   Note: Patients with previously determined ESR1 mutation using appropriately validated tests (Guardant360 CDx \\[Guardant Health\\], FoundationOne CDx, FoundationOne Liquid \\[Foundation Medicine Inc\\]) will be eligible for inclusion. This local determination can be performed either in blood or tumor samples.\n7. Radiological or objective evidence of disease progression on prior treatment with a CDK4\u002F6 inhibitor in combination with endocrine therapy for advanced disease after at least 6 months of treatment. Patients receiving CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after at least 12 months of treatment but no more than 12 months following CDK4\u002F6 inhibitor treatment completion in this scenario.\n8. Patients must have previously received at least one and no more than two lines of endocrine therapy for ABC. Progression during or within 12 months of adjuvant endocrine therapy is considered as a line of endocrine therapy for advanced disease.\n9. No prior elacestrant or other investigational SERDs, proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), or novel SERM, and\u002For PI3K\u002FAKT\u002FmTOR inhibitors, including everolimus, for advanced disease are permitted.\n\n   Note: Fulvestrant is permitted if treatment was completed administered at least 28 days before randomization.\n10. No prior chemotherapy for advanced disease is allowed.\n11. Evidence of measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion.\n12. Willingness and ability to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue or block. If a newly obtained baseline biopsy of an accessible tumor lesion is not possible to be obtained prior randomization, an archival tissue sample will be accepted.\n13. Fasting serum cholesterol ≤ 300 mg\u002FdL or 7.75 mmol\u002FL and fasting triglycerides ≤ 2.5 times the upper limit of normal (x ULN).\n14. Adequate bone marrow and organ function:\n\n    1. Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within seven days before randomization): absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; platelet count ≥ 100.0 x109\u002FL; and hemoglobin ≥ 9.0 g\u002FdL.\n    2. Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total serum bilirubin \\\u003C 1.5 x ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN; alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 3 x ULN in patients with liver and\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x ULN (≤ 3 x ULN in patients with liver metastases).\n    3. Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL\u002Fmin as calculated by Cockcroft- Gault equation.\n    4. Coagulation: International normalized ratio (INR) ≤ 1.5 x ULN, unless that the patient meets the exception described in the exclusion criteria 16.\n15. Resolution of all acute toxic effects of prior anti-cancer therapy to grade ≤ 1 as determined by the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).\n\n    Note: Patients with grade 2 alopecia are allowed.\n16. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before randomization. In addition, they agree to use one highly effective method of birth control 28 days prior to start of treatment until 120 days after the last dose of study treatments. Female patients must refrain from egg cell donation and breastfeeding during this same time period.\n17. Male participants with a female partner of childbearing potential must be surgically sterile or using a highly effective method of contraception 28 days prior to treatment until 120 days after the last dose of study treatments to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period. Not engaging in heterosexual activity (sexual abstinence) for the duration of the study and 120 days after the last dose of study treatments is an acceptable practice if this is the preferred usual lifestyle of the participant.\n18. ECOG performance status of 0-1.\n19. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\nAny patient meeting ANY of the following criteria will be excluded from the study:\n\n1. Inability to comply with study and follow-up procedures.\n2. Formal contraindication to endocrine therapy defined as visceral crisis and\u002For rapidly or symptomatic progressive visceral disease.\n3. Current participation in another therapeutic clinical trial.\n4. Treatment with approved or investigational cancer therapy within 14 days prior to randomization except for fulvestrant that must be administered completed at least 28 days before randomization.\n5. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth. Patients with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before randomization.\n6. Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).\n7. Concurrent malignancy or malignancy within three years before randomization with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.\n8. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances.\n9. History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass) or results in the inability or unwillingness to swallow pills.\n10. Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or to more than 30% of the bone marrow within four weeks prior to randomization.\n11. Major surgical procedure or significant traumatic injury within 14 days before randomization or anticipation of need for major surgery within the course of the study treatment.\n12. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    a. Symptomatic pericarditis, unstable angina pectoris, documented myocardial infarction, coronary\u002Fperipheral artery bypass graft, symptomatic cardiac heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II-IV), or cerebrovascular accident including transient ischemic attack within six months before study randomization.\n13. Concurrent uncontrolled atrial fibrillation, other ongoing cardiac dysrhythmias grade ≥ 2 as determined by NCI-CTCAE v.5.0, or prolonged QT Interval Corrected by Fridericia's formula (\\[QTcF\\] \\> 480 msec).\n14. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited, to any of the following:\n\n    1. Massive lung metastatic involvement (e.g., pleural effusion, lymphangitic carcinomatosis, etc.).\n    2. Any underlying pulmonary disorder (e.g., severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, post Coronavirus disease (COVID-19) pulmonary fibrosis, etc.).\n    3. Any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.).\n    4. Prior pneumonectomy.\n15. History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n16. Coagulopathy or any history of coagulopathy within six months before study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, patients with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to randomization.\n    2. Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than six months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to randomization.\n17. Concomitant treatment with immunosuppressive agents or chronic corticosteroids use before randomization with the following exceptions: topical applications, inhaled sprays, eye drops, mouthwash, or local injections are allowed. Patients on stable low dose of corticosteroids ( ≤ 10 mg\u002Fday of prednisone or equivalent) for at least two weeks before randomization are also permitted.\n18. Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary\u002Fherbal supplements (e.g., St. John's wort), and\u002For foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, and\u002For foods are discontinued for at least five half-lives or 14 days (whichever is shorter) prior to randomization and for the duration of the study.\n19. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n20. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Any other active uncontrolled infection at the time of screening is not allowed.\n21. Known substance abuse or any other concurrent severe and\u002For uncontrolled psychiatric or medical condition that would, in the Investigator's judgment, contraindicate patient participation.",{"count":65,"type":21},240,[67],"PHASE3","This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive\u002Fhuman epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.\n\nThe main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive\u002FHER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.\n\nRigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.",[70,71,72,33],"Advanced Breast Cancer","ER-positive Breast Cancer","HER2-negative Breast Cancer",[74,75,76,77,78],"ER-positive","HER22-negative","ESR1-mutation","CDK4\u002F6-inhibitor","Selective endocrine receptor degrader (SERD)","2026-03-30",{"date":81,"type":47},"2026-04-03",{"date":83,"type":47},"2024-12-05",{"date":85,"type":21},"2028-04",{"name":87,"class":54},"MedSIR",99,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100375887","early-phase-1-fes-imaging-to-optimize-tamoxifen-for-metastatic-breast-cancer-100375887","NCT04174352","FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer","A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations","Inclusion Criteria:\n\n* Participants must have histologically confirmed breast cancer that is metastatic or unresectable with the following:\n\n  * Estrogen receptor expression by immunohistochemistry greater than or equal to 10%\n  * ESR1 mutation identified using a Clinical Laboratory Improvement Amendments (CLIA) certified assay via tumor biopsy tissue or circulating free DNA (cfDNA)\n  * human epidermal growth factor receptor 2 (HER2) negative\n* Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone disease with at least one lesion measuring 10 mm or greater in size. (Participants with bone and non-bone disease are eligible. One disease site must meet either the measurable or evaluable criteria outlined.) Participants with liver-only disease are not eligible due to the inherent hepatic uptake related to the radiopharmaceutical's hepatobiliary route of elimination.\n* Participants must have received at least 1 prior line of endocrine therapy in the metastatic setting or have had progression within 12 months of adjuvant endocrine therapy. Prior Tamoxifen is allowed in any setting. Prior CDK4\u002F6 in the metastatic setting per NCCN guidelines is allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (See Appendix A)\n* Life expectancy of greater than 12 weeks.\n* Ability to take oral medications.\n* Informed consent: participant must be informed of the investigational nature of the study and must be able to sign a written informed consent.\n* Participants with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at least 1 month.\n* Participants must have adequate normal organ and bone marrow function as defined below:\n\n  * Absolute neutrophil count \\>\u002F= 1,000\u002FmcL\n  * Hemoglobin \\>\u002F= 9.0 g\u002FdL\n  * Platelets \\>\u002F= 100,000\u002FmcL\n  * Total bilirubin \\\u003C\u002F= 1.5 x upper limit of normal (ULN)\n  * AST (SGOT)\u002F ALT (SGPT) \\\u003C\u002F= 2.5 x ULN; \\\u003C\u002F= 5 x ULN in the setting of metastatic liver disease\n  * Creatinine \\\u003C\u002F= 1.5 x ULN or creatinine clearance \\>\u002F= 50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy within 2 weeks or major surgery within 4 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded).\n* Participants must not be receiving an ER blocking endocrine therapy (includes fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a minimum of 60 days prior to planned FES PET\u002FCT to allow for adequate uptake of FES.\n* History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of tamoxifen or \\[18F\\]-fluoroestradiol.\n* Peripheral neuropathy of severity greater than grade 1.\n* Current optic nerve disorders, retinopathy, lattice degeneration, macular degeneration, retinal vascular disorder, or retinal tears of severity greater than grade 1.\n* History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to transient medical condition and in investigator's opinion is not an active medical issue.\n* History of venous thrombosis\u002Fthromboembolic event, including pulmonary embolism and stroke.\n* Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, chronic hypokalemia, family history of long QT interval syndrome).\n* Are taking medications that are known to prolong the QT interval, unless they can be transferred to other medications ≥ 5 half-lives prior to dosing or unless the medications can be properly monitored during the study. If equivalent medication is not available, QTcF should be closely monitored.\n* Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative urine\u002Fserum pregnancy test within 14 days of tamoxifen treatment). In addition, a medically acceptable method of birth control must be used such as an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 3 months after last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.\n* Ongoing treatment with other investigational agents. Participants cannot be receiving concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.\n* History of uterine malignancy unless participant has had hysterectomy with no evidence recurrent disease for ≥ 3 years from definitive therapy.\n* Concurrent malignancy except for the following:\n\n  * Basal cell or squamous cell skin cancer\n  * In situ cervical cancer\n* The following medications are contraindicated or must be used with caution.\n\n  * Contraindicated:\n\n    * CYP2D6, CYP3A4, and CYP2C9 strong inhibitors\n    * CYP2D6, CYP3A4, and CYP2C9 strong inducers\n  * Use with caution:\n\n    * CYP2C9 sensitive substrates\n    * CYP2D6 moderate inhibitors or inducers\n    * CYP3A4 moderate inhibitors or inducers\n\nNote: Transdermal products designed for systemic delivery must be assessed for interaction potential. Topical products not designed to provide systemic delivery (including inhaled products, ophthalmologic products and transvaginal preparations) do not need to be considered.\n\nContraindicated medications are not allowed. Participants taking these concurrent medications are ineligible unless they can discontinue or switch to alternative medications prior to initiation of study drug (at least 5 half-lives).\n\nUse with caution agents are permitted if a) discontinuation is not feasible or b) no acceptable alternatives are available as determined by the treating physician; however, caution should be used. Consider monitoring by symptoms, labs or drug levels and dose adjustments of the medication.\n\n* Uncontrolled intercurrent clinically significant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","19 Years",{"count":98,"type":21},12,[100],"EARLY_PHASE1","Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always \"turned on\" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \\[18F\\]-fluoroestradiol Positron Emission Tomography\u002FComputed tomography (FES-PET\u002FCT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET\u002FCT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.",[103,33],"ERα+ Breast Cancer","2025-12-15",{"date":106,"type":47},"2025-12-22",{"date":108,"type":47},"2020-10-20",{"date":110,"type":21},"2027-12",{"name":112,"class":54},"University of Wisconsin, Madison",2,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":55},"100558269","current-status-of-treatment-for-chinese-patients-with-esr1-mutated-hrher2-advanced-breast-cancer-100558269","NCT06548919","Current Status of Treatment for Chinese Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer","Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+\u002FHER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study","Inclusion Criteria:\n\n* 1\\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.\n* 2\\. female ≥ 18 years of age\n* 3\\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \\\u003C age ≤ 60 years old with 1 year of menopause. d) Age \\\u003C60 years and receiving ovarian suppression therapy.\n* 4\\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.\n* 5\\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.\n* 6\\. have normal organ function (as assessed by the investigator).\n\nExclusion Criteria:\n\n* 1\\. women who are pregnant or breastfeeding\n* 2\\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements\n* 3\\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator","FEMALE",{"count":123,"type":21},450,"OBSERVATIONAL","This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+\u002FHER2-advanced breast cancer after failure of endocrine therapy.\n\nEpidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation\u002Fwithdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.",[33,70],"2024-08-07",{"date":129,"type":47},"2024-08-12",{"date":131,"type":47},"2024-08-08",{"date":133,"type":21},"2027-12-31",{"name":135,"class":136},"SciClone Pharmaceuticals","INDUSTRY",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":55},"100557935","safety-of-elacestrant-in-erher2--and-esr1-mutations-mbc-100557935","NCT06544577","Safety of Elacestrant in ER+\u002FHER2- and ESR1 Mutations MBC","Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+\u002FHER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world Study",{"count":144,"type":21},350,"This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+\u002FHER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.",[33,70,147],"Safety","2024-08-05",{"date":150,"type":47},"2024-08-09",{"date":152,"type":47},"2024-07-13",{"date":154,"type":21},"2026-08-01",{"name":135,"class":136}]