[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-pecoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-pecoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100628909","phase-2-ph-2-elacestrant-in-er-positive-uterine-sarcomas-100628909",false,"NCT07467772","Ph 2 Elacestrant in ER Positive Uterine Sarcomas","A Phase 2 Study Evaluating the Efficacy of Elacestrant in Patients With Estrogen Receptor Positive Uterine Sarcomas","Inclusion Criteria:\n\nParticipant must have histologically confirmed uterine sarcoma of one of the following subtypes: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa.\n\nTumor must have moderate to strong immunohistochemical expression in ≥75% of tumor cells of estrogen receptor (ER) as assessed by institutional pathology review.\n\nParticipants must have locally advanced or metastatic disease that is not amenable to surgery.\n\nParticipants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.\n\nAge ≥18 years at the time of consent\n\nECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n\nParticipants must have adequate organ and marrow function as defined below:\n\nHemoglobin ≥ 8.0 g\u002FdL\n\nabsolute neutrophil count ≥1,000\u002FmcL\n\nplatelets ≥100,000\u002FmcL\n\ntotal bilirubin ≤1.5 × institutional upper limit of normal (ULN)\n\nAST(SGOT)\u002FALT(SGPT) ≤3.0 × institutional ULN (unless liver metastases are present in which case it must be ≤ 5 × ULN)\n\nglomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2\n\nHuman immunodeficiency virus (HIV)-infected participants on effective non-CYP3A4 interacting (see Section 3.2.3) anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n\nFor participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nParticipants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nParticipants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\nParticipants must be disease-free of prior invasive malignancies for \\> 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. NOTE: If there is a history of prior malignancy, participants must not be receiving other specific treatment for that cancer.\n\nParticipants should have completed prior treatment for their cancer: chemotherapy or radiotherapy must have been completed for greater than 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.\n\nParticipants should have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n\nParticipants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n\nParticipants must have a QTc interval length of below 450 msec. QTc will be calculated via the Fridericia's formula.\n\nParticipant must be willing to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nParticipant must be able to swallow and maintain pills.\n\nAbility to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) and\u002For family member available will also be eligible.\n\nWomen of childbearing age, women who are made postmenopausal through use of GNRH agonists must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of elacestrant if the risk of conception exists.\n\nAdequate contraception is defined as one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and\u002For partner.\n\nHighly Effective Non-Hormonal Contraception\n\nMethods of birth control which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly are considered highly effective forms of contraception.\n\nThe following non-hormonal methods of contraception are acceptable:\n\n* True abstinence when this is in line with the preferred and usual lifestyle of the participant. \\[Periodic abstinence (e.g., calendar, ovulation, symptothermal post-ovulation methods) and withdrawal are not acceptable methods of contraception\\].\n* Male sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female participants, the vasectomized male partner should be the sole partner.\n\nOR Effective Non-Hormonal Contraception\n\nAlternatively, two of the following effective forms of contraception may be used instead:\n\nPlacement of non-hormonal intrauterine device (IUD) or intrauterine system (IUS). Consideration should be given to the type of device being15used, as there is higher failure rates quoted for certain types, e.g., steel or copper wire.\n\n* Condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* Occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n* The use of barrier contraceptives should always be supplemented with the use of spermicide. Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. However, spermicides alone are ineffective at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.\n\nIt should be noted that two forms of effective contraception are required. A double barrier method is acceptable, which is defined as condom and occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\nPremenopausal 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) levels within postmenopausal range; or\n* Documented Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n\nWomen 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 must be on GnRH agonist 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 - After adequate healing post-surgery\n\nExclusion Criteria:\n\nParticipants who are receiving any other investigational agents.\n\nHistory of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant.\n\nRapidly progressive, symptomatic, visceral spread of disease placing participant at risk of\n\nlife- threatening complications in the short term.\n\nParticipants with uncontrolled intercurrent illness, including but not limited to active infection, uncontrolled diabetes, cardiac disease, hypertension or conditions that in the opinion of the investigator would compromise participant safety or study participation\n\nParticipants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\nTreatment with strong CYP3A inducers\u002Finhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced. See Appendix B for a list of medications that are CYP3A inducers\u002Finhibitors.\n\nFemale participants who are pregnant or nursing.",true,"FEMALE","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is:\n\n-Elacestrant (a type of selective estrogen receptor degrader)",[27,28,29,30,31,32,33,34,35],"Uterine Sarcoma","Uterine Leiomyosarcoma","Endometrial Stromal Sarcoma","ESS","Perivascular Epithelioid Cell Tumors","Uterine Adenosarcoma","Uterine PEComa","Estrogen Receptor Positive Tumor","uLMS","RECRUITING","2026-05-21",{"date":39,"type":40},"2026-05-22","ACTUAL",{"date":42,"type":40},"2026-03-25",{"date":44,"type":21},"2028-04",{"name":46,"class":47},"Dana-Farber Cancer Institute","OTHER"]