[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"estrogen-receptor-positive-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:estrogen-receptor-positive-tumor":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,82,161,188],{"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":48},"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",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100464871","phase-4-ofs-in-premenopausal-node-breast-cancer-with-low-genomic-risk-100464871","NCT05333328","OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk","Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)","INTERSTELLAR","Inclusion Criteria:\n\n* ER+HER2- breast cancer\n* Premenopausal and age \\\u003C=50\n* T1 or T2\n* N1 including micrometastasis\n* Genomic Low Risk by OncoFREE test® (1-20)\n\nExclusion Criteria:\n\n* Postmenopausal women\n* ER-negative breast cancer","20 Years","50 Years",{"count":60,"type":21},418,[62],"PHASE4","Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).\n\nIn these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.",[65,34,66,67,68],"Breast Cancer","HER2-negative Breast Cancer","Premenopausal Breast Cancer","Node-positive Breast Cancer",[65,34,66,67,68,70,71],"Multigene assay","Ovarian-function suppression","2025-05-18",{"date":74,"type":40},"2025-05-22",{"date":76,"type":40},"2023-02-06",{"date":78,"type":21},"2033-01",{"name":80,"class":47},"Gangnam Severance Hospital",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":90,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":116,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen","ALL",{"count":92,"type":21},124,[94],"PHASE1","I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[97,98,99,100,101,102,103,66,104,105,106,34,107,108,109,110,111,112,113,114,115],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","Triple Negative Breast Cancer","HR Positive","Hormone Receptor-positive Breast Cancer","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","2025-04-01",{"date":153,"type":40},"2025-04-04",{"date":155,"type":40},"2023-02-15",{"date":157,"type":21},"2029-12-30",{"name":159,"class":47},"QuantumLeap Healthcare Collaborative",7,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":90,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":172,"phases":4,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":48},"100552584","characterization-of-biophysical-and-mechanical-parameters-on-skin-of-breast-cancer-patients-100552584","NCT06474988","Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients","Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.","Inclusion Criteria:\n\n* age between 40 and 70 years\n* subjects who are receiving treatment with tamoxifen, aromatase inhibitor or paclitaxel in adjuvant therapy +\u002F- adjuvant radiotherapy\n* subjects who are receiving hormonal therapy must have suspended any chemotherapy for at least 30 days\n\nExclusion Criteria:\n\n* presence of known chronic skin pathologies before adjuvant treatment start (psoriasis, lupus, atopic dermatitis)\n* inability to understand and will\n* unavailability to carry out all the tests required by the protocol","40 Years","70 Years",{"count":171,"type":21},150,"OBSERVATIONAL","Aim of this study is to characterize the chemical\u002Fphysical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.",[65,34],[176,177,178],"Estrogen Receptor Positive Breast Cancer","Adjuvant Treatment","Skin Toxicity","2024-06-20",{"date":181,"type":40},"2024-06-26",{"date":183,"type":40},"2024-05-27",{"date":185,"type":21},"2025-05-31",{"name":187,"class":47},"European Institute of Oncology",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":48},"100408641","phase-3-the-master-study-mammary-cancer-statin-er-positive-study-100408641","NCT04601116","The MASTER Study (MAmmary Cancer STatin ER Positive Study)","A Randomized, Multicenter, Double-blind, Placebo-controlled Comparison of Standard (Neo)Adjuvant Therapy Plus Placebo Versus Standard (Neo)Adjuvant Therapy Plus Atorvastatin in Patients With Early Breast Cancer","Patients must meet ALL of the following criteria to be eligible for randomization:\n\nInclusion Criteria:\n\n1. Women with estrogen receptor positive breast cancer who are candidates for (neo)adjuvant systemic therapy OR have received ≤3 years of adjuvant endocrine therapy.\n2. Age \\> 18 years.\n3. Performance status of ECOG ≤ 2.\n4. Prior to patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nPatients meeting ANY one of the following criteria are not eligible:\n\nExclusion Criteria:\n\n1. History of any prior (ipsi- and\u002For contralateral) invasive breast carcinoma.\n2. Ongoing (prevalent) cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors). If so, the patient can be enrolled in the observational arm.\n3. Evidence of hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).\n4. Predisposing factors for rhabdomyolysis, including hypothyroidism, reduced renal function, any muscle - or liver disease, or excessive alcohol consumption AND creatine kinase (CK) measured to less than five times the upper limit (CK only measured in case of predisposing factors).\n5. No current medication with potent CYP3A4-inhibitors (e.g. ketokonazole, erythromycin) or gemfibrozile, cyclosporin or danazol.\n6. Pregnancy or breast-feeding.\n7. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.\n8. History of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.",{"count":196,"type":21},3360,[198],"PHASE3","Given the compelling evidence supporting a protective effect of statins on breast cancer recurrence, calls for prospective clinical trials have been expressed. In this trial - the MASTER trial - we hypothesize that the addition of statin treatment to the current breast cancer treatment will improve the prognosis of women with early breast cancer. This trial is designed as follows: a randomized, multicenter, double-blind, placebo-controlled comparison of standard (neo)adjuvant therapy plus placebo versus standard (neo)adjuvant therapy plus atorvastatin in patients with early breast cancer.",[201,34],"Breast Cancer Female",[65,203,204,205,206,207],"Atorvastatin","Estrogen Receptor Positiv Tumor","Adjuvant therapy","Neoadjuvant","Statin","2021-01-13",{"date":210,"type":40},"2021-01-14",{"date":212,"type":40},"2021-01-04",{"date":214,"type":21},"2035-01-01",{"name":216,"class":47},"Aarhus University Hospital"]