[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527963":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":71,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":94,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":107,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Paradyne Networks A Foundation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Method(s)1\u002FPIF Used to Evaluate",null,"Competency Areas- Surgical care to patients with complex or recurrent neoplasms, including diagnosis and management of rare or unusual tumors.\n\nDetermining disease stage\u002Ftreatment options for individual cancer patients at time of diagnosis and throughout the disease course.\n\nProvide surgical care to patients with complex or recurrent neoplasms, including selecting for surgical therapy in combination with other forms of cancer treatment.\n\nPerforming palliative surgical.\n\nIntervention(s): Use \"Attribution\", assign category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite.\n\nDefinitions: Use list of Adverse Events.\n\nDose Units -1 mg, anastrozole. 20 mgs NOLVADEX administer to patient. Tamoxifen citrate was added to melphalan (Lphenylalanine mustard (P) and fluorouracil (F)).",[13,14],"Drug: Method(s)1 Attribution","Drug: Method(s)2 Attribution,",{"label":16,"type":10,"description":17,"interventionNames":18},"Method(s)2\u002FPIF Used to Evaluate","Competency Areas- Biologic, pharmacologic, and physiologic rationale for each form of therapy, indications, risks, and benefits of regional and systemic therapy in adjuvant and advanced disease settings.\n\nNonsurgical cancer treatment modalities, including radiotherapy, chemotherapy, immunotherapy, and endocrine therapy.\n\nNonsurgical palliative treatments.\n\nRehabilitative services, including reconstructive surgery and physical rehabilitation.\n\nTumor biology, carcinogenesis, epidemiology, tumor markers, and tumor pathology.\n\nIntervention(s): \"Attribution\" defines the relationship between the adverse event and the investigational agent(s)\u002Fintervention. Assign category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite.\n\nDefinitions: Use list of Adverse Events.\n\nDose Units- adjuvant cytotoxic chemotherapy, added to lequo, low-dose cyclophosphamide methotrexate and fluoruracil",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Method(s)1 Attribution","Intervention(s): \"Attribution\" defines the relationship between the adverse event and the investigational agent(s)\u002Fintervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite.\n\nDefinitions: Use the Adverse Event Dose Units- Indicate the dosing units (e.g., mg) administered to the patient. TAC, Reporting Group: Participants with Disease, Description: Presence of Disease as Defined by positive reference test.\n\nDosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)",[9,16],[26],"anastrazole",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Method(s)2 Attribution,","Intervention(s): -\"Attribution\" defines the relationship between the adverse event and the investigational agent(s)\u002Fintervention. Assign the appropriate category code of attribution Codes: 1-5, Descriptor, Unrelated, Unlikely, Possible, Probable, Definite.\n\nDefinitions: Use Adverse Events. Dose Units- Indicate the dosing units (e.g., mg) administered to the patient TAC. Reporting Group: Participant without Disease, Description: Absence of Disease as defined by negative reference test.\n\nDosage Form: 1mg Anastrozole, given once daily. 20 mg NOLVADEX (tamoxifen citrate) tablet given once daily, (the 20 mg NOLVADEX (tamoxifen citrate) tablet is bioequivalent to the 10 mg NOLVADEX. (tamoxifen citrate) tablets.)",[9,16],[32,33,34,35],"Tamoxifen Citrate","NOLVADEX","L phenylalanine mustard (P)","Fluorouracil (f)",[37],{"name":38,"affiliation":39,"role":40},"USCMDR Diane Chisesi, MD PhD CI","Chisesi, Diane M,: Army\u002FAir Force\u002FMil\u002FDHS\u002FOther","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"USCMDR Diane Chisesi, MD PhD LPC.","CONTACT","(719) 477-0295","Dchisesi@comcast.net",{"name":48,"role":44,"phone":45,"phoneExt":10,"email":46},"Dr. Diane Chisesi, NFS MD PhD",[50],{"facility":51,"status":10,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"PNAF Medical","Colorado Springs","Colorado","80934-2567","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-104.82136,38.83388,{"lat":61,"lon":60},[64,67,69],{"name":65,"role":44,"phone":66,"phoneExt":10,"email":46},"USCMDR Diane Chisesi, MD PhD LPC","719-477-0295",{"name":48,"role":44,"phone":45,"phoneExt":10,"email":68},"Dchisesi@gmail.com",{"name":70,"role":40,"phone":10,"phoneExt":10,"email":10},"USCMDR Diane Chisesi, PI MD PhD",{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","DR. DIANE CHISESI NFS. MD. PHD.","USCMDR Diane Chisesi P.I. Eng. NFS. MD. PhD.",[76],{"name":77,"class":78},"IRB","UNKNOWN","100527963","anastrozole-adjuvant-trial---study-of-anastrozole-compared-to-nolvadex-tamoxifen-citrate-for-adjuvant-treatment-of-early-breast-cancer-clinical-studies-adjunct-cytotoxic-chemotherapy-and-malignant-joint-tumor-100527963",false,"NCT06154590","Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer Clinical Studies), Adjunct Cytotoxic Chemotherapy and Malignant Joint Tumor","Anastrozole Adjuvant Trial - Study of Anastrozole Compared to NOLVADEX (Tamoxifen Citrate) for Adjuvant Treatment of Early Breast Cancer (Clinical Studies), Tamoxifen Citrate Was Added to Adjunct Cytotoxic Chemotherapy- Treatment of Malignant Joint Tumor.","NASBP-B-09","Inclusion Criteria:\n\n* The Median Duration of Adjuvant Treatment for 59.8 Months and 59.6 Months for Patients Receiving Anastrozole 1 mg and NOLVADEX (Tamoxifen Citrate) 20 mg.\n* Construct Patient Historical Background\n* Palliative\n* Pediatric- Under 2 Years of Age, 2-18 Years of Age (does unit adjustments )FYI\n* Interventional Procedures\n* BMD Bone Mineral Density (Data if Obtainable)\n* Notate Receptor Levels (Only Women With Both Estrogen and Progesterone\n* Levels 10 mo Fmol or Greater)\n* Notate Radiation Therapy 6 Months (Male, Prostate Cancer, or SAST, Salvage Androgen Suppression)\n* Notate Did Not Utilize Androgen Suppression as Adjunct Therapy to Radiation Therapy, Yes or no.\n* Androgen Independent Prostate Cancer\n* In addition: (for chronic, non-cancer pain), prescribers should determine whether the patient improves functionally on opioids, which could include an opioid trial, and whether the pain relief improves his\u002Fher ability to comply with the overall pain management program.\n* Chronic Pain (Benign) Inpatient\u002FOutpatient\n* Cancer Pain\n* Acute Pain, Inpatient\u002FOutpatient\n* Add here: if prudent-2.2.3.8.1.1. Dose Modification (Change)\n* Has this patient received either a dose escalation or a de-escalation of this investigational agent during this course of therapy? Use the following codes:\n* 1 = Yes, planned (i.e., the dose was changed according to protocol guidelines)\n* 2 = Yes, unplanned (i.e., the dose change was not a part of protocol guide-lines)\n* 3 = No\n* 9 = Unknown\n* Note: If the patient has received a previous escalation or de-escalation of this investigational agent and there has been no further change to the dose during this course, answer no.\n* Construct a Least Squares Linear Regression Standard Curve, Construct a Least Squares Linear Regression, Peak Height ,\n* Using data from the control (0 ppb) and fortified tissue samples, construct a least squares linear regression standard curve by plotting fortified tissue concentration against peak height (average from duplicate dose can include injection if drug is developed into injector, currently use of tablets) for the resulting equation, y = mx -t- b.\n\n  * x = concentration (ppb) of results from chemicals or tissue from prior surgeries (if any or in progress for sample tissue)\n  * y = tamoxifen citrate was added to melphalan \\[L-phenylalanine mustard (P) and fluorouracil (f) peak height (average value from duplicate does). This will assist in further studies for set up for adjutant cytotoxic chemotherapy if applicable.\n  * m = slope\n  * b = y-intercept\n* Healthy volunteers\u002Fyes\n* Will accept women 59-70 for use of combination drug-(both estrogen and progesterone receptor levels).\n\nExclusion Criteria:\n\n* At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive sub-population. This treatment arm was discontinued from the trial.",true,"ALL","44 Years","59 Years",{"count":92,"type":93},100,"ESTIMATED","90 Days","OBSERVATIONAL","At a median follow-up of 33 months, the combination of anastrozole and NOLVADEX (tamoxifen citrate) did not demonstrate any efficacy benefit when compared to NOLVADEX (tamoxifen citrate) therapy given alone in all patients as well as in the hormone receptor positive subpopulation. This treatment arm was discontinued from the trial.\n\nThis study is now a combination therapy whereas the median duration of adjuvant treatment for safety evaluation is 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and NOLVADEX (tamoxifen citrate) 20 mg, respectively.",[98,99,100,101],"Metastatic Breast Cancer","Tumor","Muscle Neoplasms","Chronic Pain",[103,104,105,106],"Dose Unit","Participants","Confidence Intervals","Cmax","NOT_YET_RECRUITING","2023-11-23",{"date":110,"type":111},"2023-12-04","ACTUAL",{"date":113,"type":93},"2024-07",{"date":115,"type":93},"2026-09",{"name":73,"class":6},1]