{"id":"endocrine-therapy-1","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00143390","NCT00143104","NCT01189461","NCT03642132","NCT05510245","NCT05654623","NCT02152124","NCT01864746","NCT01650194","NCT02175121","NCT06466187","NCT01994291","NCT04920708","NCT03975790","NCT02871791","NCT00442325","NCT00415428","NCT03538743","NCT00083993","NCT00434109","NCT01819922","NCT00138671","NCT07193394","NCT04029480","NCT02211261"],"aliases":[],"patents":[],"pricing":[],"allNames":"endocrine therapy 1","offLabel":[],"timeline":[{"date":"2006","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer) — Breast Neoplasms. Trial terminated early."},{"date":"2012","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization) — Neuroendocrine Tumor"},{"date":"2013","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters) — Healthy"}],"aiSummary":"Endocrine therapy is a treatment approach used to study conditions such as breast cancer, pancreatic neuroendocrine tumors in MEN1, and high-risk localized prostate carcinoma, among others. It involves the use of medications like letrozole, anastrozole, exemestane, or tamoxifen, which target the endocrine system to treat these conditions.","brandName":"Endocrine Therapy 1","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Endocrine Therapy 1","explanation":"Endocrine Therapy 1 works by interfering with the body's hormone system to fight cancer. Certain cancers depend on hormones like estrogen or testosterone to survive and grow. By reducing these hormones or blocking their ability to attach to cancer cells, this medication starves tumors of the signals they need to proliferate.\n\nThe drug essentially works as a brake on hormone-driven cancer growth. When cancer cells lose access to the hormones they rely on, they either stop dividing or die off entirely. This approach has proven effective because it targets the specific weakness of these hormone-dependent tumors without affecting all cells in the body equally.\n\nPatients taking this therapy typically have cancers that have been identified as hormone-responsive, meaning doctors confirmed the tumors grow in response to specific hormones. By controlling hormone levels or their activity, this medication can slow disease progression and improve survival for affected patients.","oneSentence":"Endocrine Therapy 1","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"endocrine-therapy-1","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer","phase":"discontinued","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00143390","phase":"discontinued","title":"Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurre","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":298,"indication":"Breast Neoplasms","completionDate":"2010-12","primaryEndpoint":"To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer."},{"nctId":"NCT00143104","phase":"discontinued","title":"To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutane","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":20,"indication":"Diabetes Mellitus, Type 1","completionDate":"","primaryEndpoint":"To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin."},{"nctId":"NCT01189461","phase":"discontinued","title":"Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Ede","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":46,"indication":"Anti- VGF Inhibitor","completionDate":"2012-07","primaryEndpoint":"This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema."},{"nctId":"NCT03642132","phase":"discontinued","title":"Avelumab and Talazoparib in Untreated Advanced Ovarian Cancer (JAVELIN OVARIAN PARP 100)","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":79,"indication":"Ovarian Cancer","completionDate":"2021-12","primaryEndpoint":"JAVELIN Ovarian PARP 100 (B9991030) is an open-label, randomized study designed to evaluate the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avel"},{"nctId":"NCT05510245","phase":"discontinued","title":"A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":18,"indication":"Type 2 Diabetes","completionDate":"2023-07","primaryEndpoint":"The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532)."},{"nctId":"NCT05654623","phase":"discontinued","title":"A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":624,"indication":"Advanced Breast Cancer","completionDate":"2025-01","primaryEndpoint":"A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer."},{"nctId":"NCT02152124","phase":"discontinued","title":"Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiolo","status":"discontinued","sponsor":"University Hospital, Ghent","isPivotal":false,"enrollment":21,"indication":"Acromegaly","completionDate":"2017-08","primaryEndpoint":"Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality."},{"nctId":"NCT01864746","phase":"discontinued","title":"A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2","status":"discontinued","sponsor":"GBG Forschungs GmbH","isPivotal":false,"enrollment":1250,"indication":"Breast Cancer","completionDate":"2020-08","primaryEndpoint":"The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre"},{"nctId":"NCT01650194","phase":"discontinued","title":"A Study to Determine Safety and Tolerability of Enzalutamide (MDV3100) in Combination With Abiratero","status":"discontinued","sponsor":"Astellas Pharma Global Development, Inc.","isPivotal":false,"enrollment":60,"indication":"Metastatic Castration-Resistant Prostate Cancer","completionDate":"2018-01","primaryEndpoint":"The purpose of this study was to explore the safety and tolerability of enzalutamide in combination with abiraterone acetate plus prednisone."},{"nctId":"NCT02175121","phase":"discontinued","title":"Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":172,"indication":"Diabetes Mellitus, Type II","completionDate":"2015-03","primaryEndpoint":"This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subje"},{"nctId":"NCT06466187","phase":"discontinued","title":"A Study of SGN-MesoC2 in Advanced Solid Tumors","status":"discontinued","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":19,"indication":"Carcinoma, Non-Small-Cell Lung","completionDate":"2028-05","primaryEndpoint":"This clinical trial is studying advanced solid tumors."},{"nctId":"NCT01994291","phase":"discontinued","title":"A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Anta","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":199,"indication":"Macular Edema, Diabetic","completionDate":"2015-08","primaryEndpoint":"The study hypothesis under test is that administration of the CCR2/5 antagonist has the potential to be as effective as the current treatment options for subjects with diabetic macular edema."},{"nctId":"NCT04920708","phase":"discontinued","title":"Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Withou","status":"discontinued","sponsor":"Royal Marsden NHS Foundation Trust","isPivotal":false,"enrollment":324,"indication":"Metastatic Breast Cancer","completionDate":"2026-09","primaryEndpoint":"Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy."},{"nctId":"NCT03975790","phase":"discontinued","title":"Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who ","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":479,"indication":"Rheumatoid Arthritis","completionDate":"2018-10","primaryEndpoint":"To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA "},{"nctId":"NCT02871791","phase":"discontinued","title":"Palbociclib With Everolimus + Exemestane In BC","status":"discontinued","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":41,"indication":"Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","completionDate":"2020-12","primaryEndpoint":"This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor pos"},{"nctId":"NCT00442325","phase":"discontinued","title":"Benefits Of Using Various Starting Doses Of Atorvastatin On Achievement Of Cholesterol Targets","status":"discontinued","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","isPivotal":false,"enrollment":595,"indication":"Coronary Arteriosclerosis","completionDate":"","primaryEndpoint":"European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol."},{"nctId":"NCT00415428","phase":"discontinued","title":"A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Dia","status":"discontinued","sponsor":"Pfizer's Upjohn has merged with Mylan to form Viatris Inc.","isPivotal":false,"enrollment":2776,"indication":"Heart Diseases","completionDate":"2008-09","primaryEndpoint":"The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular e"},{"nctId":"NCT03538743","phase":"discontinued","title":"4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":98,"indication":"Type 2 Diabetes Mellitus","completionDate":"2019-05","primaryEndpoint":"This is a dose-escalating study in patients with Type 2 diabetes on metformin."},{"nctId":"NCT00083993","phase":"discontinued","title":"Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer","status":"discontinued","sponsor":"Wyeth is now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":1236,"indication":"Breast Neoplasms","completionDate":"2006-10","primaryEndpoint":"In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-"},{"nctId":"NCT00434109","phase":"discontinued","title":"Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization","status":"discontinued","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","isPivotal":false,"enrollment":39,"indication":"Neuroendocrine Tumor","completionDate":"2012-02","primaryEndpoint":"The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors."},{"nctId":"NCT01819922","phase":"discontinued","title":"Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":12,"indication":"Healthy","completionDate":"2013-10","primaryEndpoint":"This study is designed to assess the effect of one single dose of PF-05175157 on metabolic and cardiopulmonary parameters before, during and after treadmill exercise in healthy volunteers."},{"nctId":"NCT00138671","phase":"discontinued","title":"A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With C","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":105,"indication":"Diabetes Mellitus","completionDate":"2008-09","primaryEndpoint":"A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Chronic Obstructive Pulmonary Disease."},{"nctId":"NCT07193394","phase":"discontinued","title":"Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer","status":"discontinued","sponsor":"Institut Curie","isPivotal":false,"enrollment":20,"indication":"Metastatic Breast Cancer ( HER2 Negative)","completionDate":"2028-12","primaryEndpoint":"The H3RAKLES trial would allow patients with a progressive metastatic breast cancer to have access to one more line of systemic therapy."},{"nctId":"NCT04029480","phase":"discontinued","title":"Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)","status":"discontinued","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":166,"indication":"Type 2 Diabetes Mellitus","completionDate":"2025-04","primaryEndpoint":"This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin."},{"nctId":"NCT02211261","phase":"discontinued","title":"A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinet","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":84,"indication":"Type 2 Diabetes Mellitus","completionDate":"2017-01","primaryEndpoint":"A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}