{"id":"letrozole-2-5mg","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT03709082","NCT06525675","NCT02894398","NCT03573648","NCT02297438","NCT01248416","NCT01740427","NCT02040857","NCT03936270"],"aliases":[],"patents":[],"pricing":[],"allNames":"letrozole 2.5mg","offLabel":[],"timeline":[{"date":"2016","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopaus) — Breast Neoplasms"},{"date":"2018","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negat) — Breast Cancer"}],"aiSummary":"Letrozole 2.5mg is an aromatase inhibitor approved for hormone receptor-positive breast cancer treatment in postmenopausal women. It works by blocking the enzyme aromatase, which converts other hormones into estrogen in the body. A key clinical differentiator is its potency and favorable tolerability profile compared to other aromatase inhibitors.","brandName":"Letrozole 2.5mg","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"2.5 mg letrozole per day, administered orally (continuous treatment)","explanation":"Letrozole is a targeted cancer therapy that works by shutting down estrogen production in postmenopausal women. In these women, most estrogen is made through a process involving an enzyme called aromatase, which converts other hormones into estrogen in fatty tissues throughout the body. By blocking this enzyme, letrozole dramatically reduces circulating estrogen levels.\n\nEstrogen-dependent breast cancers rely on this hormone to survive and multiply. When letrozole cuts off estrogen supply, cancer cells either stop growing or die. This approach is particularly effective for hormone receptor-positive breast cancers, which have proteins on their surface that bind to estrogen and use it as a growth signal. By removing the fuel source, letrozole essentially puts the brakes on tumor progression.\n\nUnlike some older breast cancer treatments that work throughout the whole body indiscriminately, letrozole specifically targets the estrogen-production pathway. This selective mechanism allows it to control cancer while minimizing damage to healthy cells that don't depend on estrogen for survival, though some side effects can still occur due to the body-wide reduction in estrogen levels.","oneSentence":"2.5 mg letrozole per day, administered orally (continuous treatment)","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"letrozole-2-5mg","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Metastatic Breast Cancer","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03709082","phase":"Phase 1/2","title":"Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (H","status":"Terminated","sponsor":"University of Kansas Medical Center","isPivotal":false,"enrollment":3,"indication":"HER2-positive Breast Cancer","completionDate":"2020-03","primaryEndpoint":"This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1)."},{"nctId":"NCT06525675","phase":"N/A","title":"Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Stu","status":"Completed","sponsor":"MedSIR","isPivotal":false,"enrollment":419,"indication":"Metastatic Breast Cancer","completionDate":"2024-05","primaryEndpoint":"The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozol"},{"nctId":"NCT02894398","phase":"Phase 2","title":"Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant","status":"Completed","sponsor":"iOMEDICO AG","isPivotal":false,"enrollment":388,"indication":"Breast Cancer","completionDate":"2023-02","primaryEndpoint":"The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who"},{"nctId":"NCT03573648","phase":"Phase 2","title":"Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer","status":"Active Not Recruiting","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","isPivotal":false,"enrollment":33,"indication":"Breast Cancer","completionDate":"2026-09","primaryEndpoint":"Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio"},{"nctId":"NCT02297438","phase":"Phase 3","title":"A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asi","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":340,"indication":"Breast Neoplasms","completionDate":"2020-08","primaryEndpoint":"The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with"},{"nctId":"NCT01248416","phase":"Phase 3","title":"Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathi","status":"Completed","sponsor":"Nemours Children's Clinic","isPivotal":false,"enrollment":76,"indication":"Idiopathic Short Stature","completionDate":"2016-09","primaryEndpoint":"When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end."},{"nctId":"NCT01740427","phase":"Phase 3","title":"A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopaus","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":666,"indication":"Breast Neoplasms","completionDate":"2016-02","primaryEndpoint":"The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/"},{"nctId":"NCT02040857","phase":"Phase 2","title":"Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negat","status":"Completed","sponsor":"Dana-Farber Cancer Institute","isPivotal":false,"enrollment":162,"indication":"Breast Cancer","completionDate":"2018-05","primaryEndpoint":"This research study is evaluating a drug called Palbociclib in combination with endocrine therapy as a possible treatment for hormone receptor positive breast cancer."},{"nctId":"NCT03936270","phase":"Phase 2","title":"Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER","status":"Completed","sponsor":"Latin American Cooperative Oncology Group","isPivotal":false,"enrollment":43,"indication":"Ovarian Cancer","completionDate":"2022-01","primaryEndpoint":"The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who ha"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1444"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":33,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}