Femara

(Letrozole)

ApprovedSmall molecule

Letrozole is used to treat hormone receptor-positive breast cancer in postmenopausal women. It works by lowering estrogen levels in the body, which helps slow or stop the growth of breast cancer cells that depend on estrogen.[2] Femara is currently approved and in use across 70 indications[4].[1]

Femara is one of 816 small molecule programs targeting Glioma. It is currently in Approved.

Indications

521

Total Trials

Active Trials

815

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

HyperplasiaActive, not recruiting

Gestational Trophoblastic NeoplasmApproved

Bone MetastasisActive, not recruiting

Vitamin D DeficiencyActive, not recruiting

Uterine LeiomyosarcomaActive, not recruiting

MetastasisApproved

Paroxysmal Familial Ventricular FibrillationApproved

AdenomyosisApproved

Uterine LeiomyomaActive, not recruiting

GliomaPhase 1

Active, not recruiting

HyperplasiaPhase 2/Phase 3

Active, not recruiting

Gestational Trophoblastic NeoplasmApproved

Approved

Bone MetastasisPhase 2

Active, not recruiting

Vitamin D DeficiencyPhase 2

Active, not recruiting

Uterine LeiomyosarcomaPhase 2

Active, not recruiting

MetastasisApproved

Approved

Paroxysmal Familial Ventricular FibrillationApproved

Approved

AdenomyosisApproved

Approved

Uterine LeiomyomaPhase 1

Active, not recruiting

Showing 10 of 70 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Femara

Halaven

38 3

Tecentriq

Roche

Preclinical

36 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Voltaren

Novartis

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

Spravato

WWim Janssens

Preclinical

2 8

Tricor

JJagotec

Preclinical

1 9

Nubain

AAultman Health Foundation

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Breast Cancer

NCT02947685

Phase 2Recruiting

Abemaciclib

NCT05766410

Phase 2Active, not recruiting

Breast Cancer

NCT03879577

Q4 2026

Phase 2Active, not recruiting

Breast Cancer

NCT03161353

Phase 2Active, not recruiting

Breast Cancer

NCT02712723

Phase 3Active, not recruiting

Breast Cancer

NCT05909397

Clinical

Trials by Indication[1]

Breast Cancer113 trials

Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Recruiting·UUniversity of Washington·Phase 2·NCT06179303·60 enrolled

Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer

Unknown status·—·Phase 2·NCT04942899·70 enrolled

Study of Anastrozole, Letrozole, or Exemestane With or Without Tamoxifen in Treating Postmenopausal Women With Hormone-Responsive Breast Cancer That Has Been Completely Removed By Surgery

Unknown status·GGruppo Italiano Mammella (GIM)·Phase 3·NCT00541086·3,697 enrolled

Show 110 more trials

Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 2·NCT04191382·105 enrolled

Study of Exemestane After Anastrozole or Letrozole Treatment of Postmenopausal Women With Hormone Responsive Breast Cancer

Unknown status·FFudan University·Phase 3·NCT00902954·540 enrolled

Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer

Completed·MMayo Clinic··NCT00719966·109 enrolled

Letrozole After Tamoxifen in Treating Women With Breast Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00003140·5,187 enrolled

Study of Breast Cancer Prevention by Letrozole in High Risk Women

Completed·—·Phase 2·NCT00579826·55 enrolled

A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer

Completed·—·Phase 2·NCT03306472·198 enrolled

Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT01430585·14 enrolled

Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00330317·300 enrolled

A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04546009·992 enrolled

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Recruiting·OOana Danciu·Phase 2·NCT05467891·200 enrolled

Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00073528·1,286 enrolled

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05774951·4,300 enrolled

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Completed·GGBG Forschungs GmbH·Phase 2·NCT03555877·56 enrolled

Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00083993·1,236 enrolled

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

Completed·UUNICANCER·Phase 2·NCT02400567·125 enrolled

Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.

Not yet recruiting·—·Phase 2·NCT07394946·126 enrolled

Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00237211·31 enrolled

Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

Terminated·UUniversity of Washington·Phase 2·NCT00498901·1 enrolled

Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07492394·60 enrolled

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT03099174·133 enrolled

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Completed·UUniversity of California, San Francisco·Phase 1·NCT03554044·20 enrolled

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06760637·1,020 enrolled

Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Recruiting·EEmory University·Phase 1·NCT05464810·40 enrolled

A Clinical Trial to Compare Efficacy and Tolerability of Atorvastatin in Addition to Endocrine Treatment With Focus on Mechanisms of Resistance to Endocrine Treatment (Fulvestrant/Aromatase Inhibitors) in Patients With Advanced Breast Cancer

Completed·LLund University Hospital·Phase 2·NCT02958852·126 enrolled

Protocol for Women at Increased Risk of Developing Breast Cancer

Completed·—·Phase 2·NCT00291135·42 enrolled

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Not yet recruiting·RRegion Örebro County·Phase 3·NCT06223698·3,832 enrolled

Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00880009·16 enrolled

Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

Completed·—··NCT00681928·72 enrolled

Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment

Completed· Novartis logo

Novartis·Phase 2·NCT00237198·47 enrolled

Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT03096847·502 enrolled

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

Active, not recruiting·AAlliance Foundation Trials, LLC.·Phase 3·NCT02947685·518 enrolled

Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer

Terminated·MMayo Clinic·Phase 2·NCT00573755·4 enrolled

Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00422903·92 enrolled

To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

Completed·EETOP IBCSG Partners Foundation·Phase 2·NCT03644186·147 enrolled

The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer

Completed·JJohns Hopkins University·Phase 2·NCT04129216·30 enrolled

Letrozole in the Treatment of 1st and 2nd Line Hormone Receptor Positive Breast Cancer: Pre-therapeutic Risk Assessment

Terminated· Novartis logo

Novartis·Phase 4·NCT00241046·13 enrolled

Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

Unknown status·ZZhiyong Yu·Phase 2/3·NCT03373708·200 enrolled

Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer

Completed·CCentre Oscar Lambret·Phase 3·NCT00893061·44 enrolled

Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer

Unknown status·FFudan University·Phase 1/2·NCT03772353·59 enrolled

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

Completed·UUniversity of Washington·Phase 2·NCT00194779·50 enrolled

Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

Terminated·IIntarcia Therapeutics·Phase 3·NCT00267553·200 enrolled

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

Completed·IiOMEDICO AG·Phase 2·NCT02894398·388 enrolled

Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer

Active, not recruiting·UUniversity of Chicago·Phase 2·NCT03879577·53 enrolled

Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients

Unknown status·CChinese Academy of Medical Sciences··NCT02765373·500 enrolled

A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Terminated·—·Phase 3·NCT02730091·98 enrolled

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

Completed· Roche logo

Roche·Phase 1·NCT00960960·71 enrolled

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

Active, not recruiting·QQamar Khan·Phase 2·NCT02712723·121 enrolled

Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

Withdrawn·TTechnical University of Munich·Phase 3·NCT00403182

Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

Enrolling by invitation·PPeking University·Phase 2·NCT06650748·100 enrolled

Neoadjuvant Study Chemotherapy vs Letrozole + Abemaciclib in HR+/HER2- High/Intermediate Risk Breast Cancer Patients

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 2·NCT04293393·200 enrolled

Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00332852·655 enrolled

Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT00050011·602 enrolled

A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03962647·31 enrolled

A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

Terminated· Roche logo

Roche·Phase 2·NCT00796107·6 enrolled

Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer

Unknown status·—·Phase 2·NCT00280930·60 enrolled

Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole in HR+/HER2-negative Early Breast Cancer Patients (VENTANA)

Completed·SSOLTI Breast Cancer Research Group·Phase 1·NCT02802748·60 enrolled

Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer.

Completed·—·N/A·NCT02010021·17 enrolled

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 4·NCT02679755·252 enrolled

A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04872608

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

Withdrawn·FFred Hutchinson Cancer Center·Phase 4·NCT03238703

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03822468·376 enrolled

Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

Completed·NNHS Tayside·N/A·NCT02701348·31 enrolled

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Completed· Novartis logo

Novartis·Phase 2·NCT03056755·383 enrolled

A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer

Unknown status·JJinming Yu·Phase 2·NCT04095390·60 enrolled

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Terminated·TTranslational Research in Oncology·Phase 2·NCT02115048·44 enrolled

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Unknown status·HHaihe Biopharma Co., Ltd.·Phase 1·NCT04856371·228 enrolled

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Terminated· Roche logo

Roche·Phase 1·NCT01296555·674 enrolled

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Completed· Pfizer logo

Pfizer·Phase 3·NCT02297438·340 enrolled

BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00708214·28 enrolled

Sirolimus for Injection (Albumin-bound) in Combination With Endocrine Therapy for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Who Have Failed Standard Therapy

Active, not recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT06957379·78 enrolled

Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer

Terminated· Novartis logo

Novartis·Phase 4·NCT00171847·93 enrolled

Breast Cancer & Antiestrogenic Therapy & Brain

Not yet recruiting·IInternational Research Training Group 2804··NCT06346457·180 enrolled

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT03128619·10 enrolled

Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 1/2·NCT01105312·28 enrolled

Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate

Completed· Pfizer logo

Pfizer·Phase 3·NCT02600923·131 enrolled

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT02278120·672 enrolled

Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer

Unknown status·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03633331·93 enrolled

Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT03007979·55 enrolled

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00553410·4,884 enrolled

Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer

Completed·NNSABP Foundation Inc·Phase 2·NCT03628066·24 enrolled

Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer

Completed·MMayo Clinic·Phase 2·NCT04294225·161 enrolled

Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene

Unknown status·KKorean Breast Cancer Study Group·Phase 4·NCT01072318·495 enrolled

Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05909397·59 enrolled

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT05514054·8,000 enrolled

Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer

Completed·IIntarcia Therapeutics·Phase 3·NCT00044291·865 enrolled

Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT01231659·72 enrolled

Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT01698918·202 enrolled

Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

Unknown status·CChinese Academy of Medical Sciences·Phase 2·NCT02313051·200 enrolled

Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer

Completed·UUniversity of Alabama at Birmingham·Phase 1/2·NCT02520063·15 enrolled

Phase 2, Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-sensitive Metastatic Breast Cancer

Withdrawn·VVanderbilt-Ingram Cancer Center·Phase 2·NCT01013506

Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00332709·83 enrolled

Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer

Terminated·WWashington University School of Medicine·Phase 2·NCT02907918·26 enrolled

Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density

Completed·NNCIC Clinical Trials Group·Phase 2·NCT00238316·68 enrolled

Relationship Between Hypoxia and Endocrine Response in Human Breast Cancer

Unknown status·FFudan University··NCT01814449·130 enrolled

A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01684215·61 enrolled

Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

Completed·UUniversity of Michigan Rogel Cancer Center··NCT01814397·50 enrolled

Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT00084396·115 enrolled

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

Terminated· Sanofi logo

Sanofi·Phase 3·NCT04478266·1,068 enrolled

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02333370·88 enrolled

Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer

Terminated·AAntisoma Research·Phase 2·NCT00770354·110 enrolled

Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer

Recruiting·UUniversity of Washington·Phase 4·NCT05183828·68 enrolled

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Recruiting·FFudan University·Phase 2·NCT05582499·716 enrolled

Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer

Completed·EETOP IBCSG Partners Foundation·Phase 3·NCT00004205·8,028 enrolled

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)

Terminated· Novartis logo

Novartis·Phase 2·NCT01919229·14 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer

Terminated·WWashington University School of Medicine·Phase 2·NCT01368263·8 enrolled

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Completed·RRutgers, The State University of New Jersey·Phase 1/2·NCT00634634·52 enrolled

Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery

Completed·IImperial College London·Phase 3·NCT00963729·756 enrolled

PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

Active, not recruiting·SSeoul National University Hospital·Phase 2·NCT03900637·122 enrolled

Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.

Active, not recruiting·MMedSIR·Phase 2·NCT03161353·377 enrolled

Polycystic Ovary Syndrome6 trials

Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

Unknown status·—·Phase 3·NCT03009838·150 enrolled

Effect of ALA Combined With Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

Recruiting·—·Phase 3·NCT06418347·150 enrolled

Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01431352·420 enrolled

Show 3 more trials

Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

Withdrawn·CCRG UZ Brussel·Phase 4·NCT04002635

Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

Completed·MMansoura University·N/A·NCT00956267·260 enrolled

Polycystic Ovary Syndrome (PCOS): Effect Of Letrozole and Berberine

Unknown status·HHeilongjiang University of Chinese Medicine·N/A·NCT01116167·660 enrolled

Pregnancy5 trials

Comparison of the Effectiveness of Single-Dose Methotrexate Protocol With Letrozole + Single-Dose Methotrexate in the Medical Treatment of Patients Diagnosed With Ectopic Pregnancy

Completed·YYuzuncu Yil University·N/A·NCT06504082·60 enrolled

Assessment of the Efficacy of Letrozole in the Treatment of Ectopic Pregnancy

Unknown status·TTehran University of Medical Sciences·Phase 1/2·NCT05918718·150 enrolled

Sequential Letrozole and Methotrexate Therapy Role in Treatment of Tubal Ectopic Pregnancy

Completed·ZZagazig University·N/A·NCT06426979·200 enrolled

Show 2 more trials

Study on Combined Use of Letrozole, Mifepristone and Misoprostol in Termination of Pregnancy

Unknown status·TThe University of Hong Kong·N/A·NCT01475318·50 enrolled

The Use of Letrozole or Mifepristone for Pretreatment of Medical Termination of Pregnancy

Recruiting·KKK Women's and Children's Hospital·Phase 4·NCT05341817·144 enrolled

Abortion5 trials

Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Unknown status·SShereen Rady Abou El-fetouh·Phase 4·NCT04590482·110 enrolled

Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Completed·—·Phase 2/3·NCT02401425·423 enrolled

Randomized Study of Letrozole and Trilostane for Medical Abortion

Terminated·KKristina Gemzell Danielsson·Phase 2·NCT01615211·36 enrolled

Show 2 more trials

Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

Completed·—·Phase 2/3·NCT02405156·400 enrolled

Different Methods of Termination of Second Trimester Abortion

Unknown status·—·N/A·NCT03400683·150 enrolled

Endometrial Cancer5 trials

Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer

Recruiting·JJonsson Comprehensive Cancer Center·Phase 2·NCT04469764·32 enrolled

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Completed·GGOG Foundation·Phase 2·NCT02228681·74 enrolled

A Study of Letrozole in the Treatment of Endometrial Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00333086·36 enrolled

Show 2 more trials

Abemaciclib and Letrozole in Treating Patients With Endometrial Cancer

Completed·NNorthwestern University·Phase 1·NCT04049227·27 enrolled

Abemaciclib and Letrozole to Treat Endometrial Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT04393285·53 enrolled

51 more indications

Ovulation Induction4 trials

Comparison Between Two Ovulation Induction Therapies and LOD on Clinical Outcomes in CC-Resistant PCOS Women

Completed·—·Phase 3·NCT06486870·183 enrolled

Administration of Single High Dose Letrozole for Ovulation Induction

Completed·MMount Sinai Hospital, Canada·Phase 4·NCT02703649·36 enrolled

Letrozole Versus Clomifene Citrate for Ovulation Induction

Completed·UUniversity of Nottingham·Phase 4·NCT00478504·159 enrolled

Show 1 more trial

Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS

Completed·—·N/A·NCT03181919·90 enrolled

Polycystic Ovarian Syndrome3 trials

Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome.

Completed·—·Phase 3·NCT02304107·140 enrolled

Letrozole or Combined Clomiphene Citrate Metformin as a First Line Treatment in Women With Polycystic Ovarian Syndrome

Completed·—·N/A·NCT01679574·200 enrolled

Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome

Not yet recruiting·—·Phase 3·NCT06405178·500 enrolled

Treatment3 trials

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Letrozole Treatment in Normal and GnRH Deficient Women

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT00351416·15 enrolled

Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Completed·EErcan Bastu·N/A·NCT02158689·80 enrolled

Ovarian Stimulation2 trials

Mapping the Endocrine Determinants of Ovarian Stimulation to Optimize Outcomes in Fresh Embryo Transfer Cycles

Completed·—·Phase 2/3·NCT02939898·33 enrolled

Effect of Addition of Aromatase Inhibitor to Ovarian Stimulation Therapy in IVF Treatment

Completed·—·Phase 2/3·NCT02946684·129 enrolled

Postmenopausal Women2 trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

Completed· Novartis logo

Novartis·Phase 3·NCT02941926·3,246 enrolled

Letrozole With or Without Zoledronate in Treating Healthy Postmenopausal Women With High Breast Density

Completed·UUniversity of Virginia·N/A·NCT00114270

Abemaciclib2 trials

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

Completed·MMedSIR·Phase 2·NCT04603183·162 enrolled

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05766410·60 enrolled

Infertility2 trials

Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

Completed·—·Phase 3·NCT02739516·108 enrolled

Graceful Lifestyle Changes Study for PCOS and Infertility

Unknown status·UUniversity of British Columbia·N/A·NCT02630485·240 enrolled

Ovarian Cancer2 trials

Ribociclib and Letrozole Treatment in Ovarian Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT03673124·51 enrolled

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2/3·NCT02101788·260 enrolled

Endocrine Therapy2 trials

Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy

Recruiting·YYongsheng Wang·Phase 4·NCT05809024·100 enrolled

Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast

Unknown status·FFirst Hospital of China Medical University··NCT04666805·1,354 enrolled

Bone Metastasis1 trial

Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis

Completed·EEmory University·Phase 2·NCT03691493·36 enrolled

Neoadjuvant1 trial

Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

Recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT04614194·60 enrolled

Pancreatic Cancer1 trial

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Intracytoplasmic Sperm Injection1 trial

Different Protocols in Ovarian Stimulation in Intracytoplasmic Sperm Injection Cycles

Withdrawn·—·N/A·NCT04193930

Endocrinology1 trial

Endocrinology Profile in Patients Undergoing Clomiphene, Letrozole, and Combination Clomiphene and Letrozole Cycles

Withdrawn·UUniversity Hospitals Cleveland Medical Center·N/A·NCT02377479

Ovarian Tumor1 trial

Letrozole in Patients With Ovarian Tumors

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00505661·16 enrolled

Advanced Solid Cancer1 trial

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093351·79 enrolled

Primary Peritoneal Cancer1 trial

Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Active, not recruiting·NNRG Oncology·Phase 3·NCT04095364·450 enrolled

Overweight1 trial

GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients

Completed·UUniversity of Maryland, Baltimore·N/A·NCT02095184·42 enrolled

Resistance1 trial

FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole

Completed·JJules Bordet Institute·Phase 2·NCT00199134·49 enrolled

IVF Outcome1 trial

Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women

Unknown status·UUmm Al-Qura University·N/A·NCT05106712·700 enrolled

Breast Neoplasm1 trial

Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

Completed· Pfizer logo

Pfizer·Phase 2·NCT00062751·108 enrolled

Fasting Conditions1 trial

Bioavailability Study of Letrozole Tablets 2.5 mg of Dr.Reddy's Under Fasting Conditions

Completed·—·Phase 1·NCT01375452·36 enrolled

Anovulation1 trial

Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation

Active, not recruiting·RRachel Mejia·Phase 4·NCT05206448·190 enrolled

Magnetic Resonance Imaging (MRI)1 trial

Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)

Completed·MMount Sinai Hospital, Canada·Phase 2·NCT01129622·16 enrolled

Outcome1 trial

Does Letrozole Improve the Outcomes and/or Reduce the Cost of IVF-ET Cycles?

Withdrawn·CCenter for Human Reproduction·Phase 4·NCT00804960

Ovarian cyst1 trial

Letrozole in Preventing Recurrence of Endometrioma Following Laparoscopic Ovarian Cystectomy

Recruiting·TThe University of Hong Kong·N/A·NCT05487092·194 enrolled

CLE1 trial

Letrozole in Stimulated IVF Cycles

Completed·TThe University of Hong Kong·Phase 3·NCT02912988·900 enrolled

Obesity1 trial

Reproductive Hormonal Alterations in Obesity

Completed·UUniversity of Colorado, Denver·N/A·NCT01457703·62 enrolled

Efficacy and Safety1 trial

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

Phase II1 trial

Phase II Study of Everolimus Beyond Progression

Terminated·EEmory University·Phase 2·NCT02269670·3 enrolled

Ovarian1 trial

Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

Completed·UUniversity of Saskatchewan·N/A·NCT00565240·41 enrolled

Myoma1 trial

Pilot of Letrozole for Uterine Myomas

Completed·UUniversity of California, San Francisco·Phase 4·NCT02470741·12 enrolled

Advanced Cancer1 trial

A Study of LY3023414 in Participants With Advanced Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01655225·156 enrolled

Advanced Solid Tumors1 trial

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

Recruiting·AAvenzo Therapeutics, Inc.·Phase 1/2·NCT06998407·380 enrolled

Completed·NNew Hope Fertility Center·N/A·NCT02865681·4 enrolled

Endometrial Carcinoma1 trial

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03008408·90 enrolled

Menopause1 trial

A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause

Completed· Pfizer logo

Pfizer·Phase 2·NCT06465368·121 enrolled

Miscarriage1 trial

Letrozole Versus Mifepristone and Misoprostol in Silent Miscarriage

Not yet recruiting·TThe University of Hong Kong·N/A·NCT06733727·884 enrolled

Endometriosis1 trial

Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

Completed·UUniversity of California, San Francisco·Phase 2·NCT04002141·60 enrolled

PET1 trial

Palbociclib and FES PET

Completed·UUniversity Medical Center Groningen·Phase 2·NCT02806050·30 enrolled

Progesterone1 trial

Letrozole, Herceptin in Her2neu +, Estrogen Receptor [ER] and/or Progesterone Receptor [PR] Positive, MBC

Completed·—·Phase 2·NCT00134680·33 enrolled

Growth1 trial

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Completed·SStanford University·Phase 4·NCT02137538·79 enrolled

Embryo Transfer1 trial

Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

Unknown status·NNavy General Hospital, Beijing·N/A·NCT02775877·100 enrolled

Vitamin D Deficiency1 trial

Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

Completed·UUniversity of Washington·Phase 2·NCT00416715·100 enrolled

Obese1 trial

Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 1·NCT02538484·24 enrolled

Prevention1 trial

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

Completed·MMedSIR·Phase 2·NCT04300790·69 enrolled

Fed1 trial

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01367626·28 enrolled

Hepatopulmonary Syndrome1 trial

Letrozole in Patients With Hepatopulmonary Syndrome

Terminated·MMayo Clinic·Phase 2·NCT04577001·1 enrolled

Unspecified3 trials

Antagonist/Letrozole in Poor Responders

Completed·YYazd Research & Clinical Center for Infertility·Phase 1/2·NCT00823004·120 enrolled

Detect V / CHEVENDO (Chemo vs. Endo)

Active, not recruiting·PProf. Wolfgang Janni·Phase 3·NCT02344472·271 enrolled

Evaluation of Predictive Factors Regarding the Effectivity of Aromatase Inhibitor Therapy (PreFace)

Unknown status·IInstitut fuer Frauengesundheit·Phase 4·NCT01908556·3,545 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 25, 1997

FEMARA

NDA NDA020726

Sources

References

[1]
ClinicalTrials.gov — 521 trial records for Letrozole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Femara drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Letrozole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Letrozole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020726). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 19a1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Femara

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Breast Cancer113 trials

Polycystic Ovary Syndrome6 trials

Pregnancy5 trials

Abortion5 trials

Endometrial Cancer5 trials

Ovulation Induction4 trials

Polycystic Ovarian Syndrome3 trials

Treatment3 trials

Ovarian Stimulation2 trials

Postmenopausal Women2 trials

Abemaciclib2 trials

Infertility2 trials

Ovarian Cancer2 trials

Endocrine Therapy2 trials

Bone Metastasis1 trial

Neoadjuvant1 trial

Pancreatic Cancer1 trial

Intracytoplasmic Sperm Injection1 trial

Endocrinology1 trial

Ovarian Tumor1 trial

Advanced Solid Cancer1 trial

Primary Peritoneal Cancer1 trial

Overweight1 trial

Resistance1 trial

IVF Outcome1 trial

Breast Neoplasm1 trial

Fasting Conditions1 trial

Anovulation1 trial

Magnetic Resonance Imaging (MRI)1 trial

Outcome1 trial

Ovarian cyst1 trial

CLE1 trial

Obesity1 trial

Efficacy and Safety1 trial

Phase II1 trial

Ovarian1 trial

Myoma1 trial

Advanced Cancer1 trial

Advanced Solid Tumors1 trial

Clinical Trial1 trial

Congenital Adrenal Hyperplasia1 trial

In Vitro Fertilization1 trial

Endometrial Carcinoma1 trial

Menopause1 trial

Miscarriage1 trial

Endometriosis1 trial

PET1 trial

Progesterone1 trial

Growth1 trial

Embryo Transfer1 trial

Vitamin D Deficiency1 trial

Obese1 trial

Prevention1 trial

Fed1 trial

Hepatopulmonary Syndrome1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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