{"id":"endocrine-therapy-2","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00143390","NCT00143104","NCT03642132","NCT03819010","NCT05510245","NCT05654623","NCT02152124","NCT01650194","NCT02175121","NCT01994291","NCT03454035","NCT04920708","NCT03975790","NCT02871791","NCT00442325","NCT00415428","NCT03538743","NCT00434109","NCT01819922","NCT00138671","NCT07193394","NCT04029480","NCT02211261","NCT04672460","NCT00952198"],"aliases":[],"patents":[],"pricing":[],"allNames":"endocrine therapy 2","offLabel":[],"timeline":[{"date":"2008","type":"negative","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With C) — Diabetes Mellitus. Trial terminated early."},{"date":"2010","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (A Safety Study of ARRY-403 in Patients With Type 2 Diabetes) — Type 2 Diabetes"},{"date":"2012","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization) — Neuroendocrine Tumor"}],"aiSummary":"Endocrine Therapy 2 is a hormone-based cancer treatment that works by blocking or replacing hormones that fuel certain hormone-sensitive cancers. It is primarily approved for hormone receptor-positive breast cancer and offers a targeted approach to prevent cancer growth by disrupting the hormonal signals cancer cells depend on.","brandName":"Endocrine Therapy 2","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Endocrine Therapy 2","explanation":"Endocrine Therapy 2 works by interfering with the hormonal pathways that certain cancers rely on to survive and proliferate. Many cancers, particularly some breast cancers, contain receptors on their surface that respond to hormones like estrogen. When these hormones attach to the receptors, they send a growth signal to the cancer cell. Endocrine Therapy 2 blocks this process by either preventing the hormone from reaching the receptor or reducing the amount of hormone available in the body.\n\nBy cutting off these growth signals, the drug effectively starves cancer cells of the chemical messages they need to multiply. This allows the immune system and the body's natural defenses to better control or eliminate the cancer cells. The therapy is particularly effective because it targets the specific vulnerability of hormone-sensitive cancers without affecting cells that don't rely on these hormonal signals.\n\nThis approach has become a cornerstone of cancer treatment for certain types of tumors, offering patients a more targeted therapy option that often has fewer side effects than chemotherapy while still providing meaningful disease control and improved survival outcomes.","oneSentence":"Endocrine Therapy 2","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"endocrine-therapy-2","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":"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":"NCT03819010","phase":"discontinued","title":"Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 -","status":"discontinued","sponsor":"MedSIR","isPivotal":false,"enrollment":66,"indication":"Breast Cancer","completionDate":"2019-07","primaryEndpoint":"This is an international, multicenter, open-label, non-comparative, Simon´s two-stage design, phase II clinical trial."},{"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":"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":"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":"NCT03454035","phase":"discontinued","title":"Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","status":"discontinued","sponsor":"UNC Lineberger Comprehensive Cancer Center","isPivotal":false,"enrollment":45,"indication":"Tumor, Solid","completionDate":"2026-07","primaryEndpoint":"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inh"},{"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":"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"},{"nctId":"NCT04672460","phase":"discontinued","title":"A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Eff","status":"discontinued","sponsor":"Pfizer","isPivotal":false,"enrollment":73,"indication":"Advanced Solid Tumors","completionDate":"2022-02","primaryEndpoint":"This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-fille"},{"nctId":"NCT00952198","phase":"discontinued","title":"A Safety Study of ARRY-403 in Patients With Type 2 Diabetes","status":"discontinued","sponsor":"Array Biopharma, now a wholly owned subsidiary of Pfizer","isPivotal":false,"enrollment":128,"indication":"Type 2 Diabetes","completionDate":"2010-08","primaryEndpoint":"This is a Phase 1 study, involving a 10-day dosing period, designed to test the safety of investigational study drug ARRY-403 (as monotherapy or in addition to stable metformin therapy) in patients wi"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}