Therapy Detail

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Therapy Name Letrozole
Synonyms
Therapy Description

Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis, and is approved for postmenopausal women with hormone receptor positive breast cancer (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Letrozole Femara Letrozol Aromatase Inhibitor 3 Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis, and is approved for postmenopausal women with hormone receptor positive breast cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant estrogen-receptor positive breast cancer predicted - sensitive Letrozole Phase III Actionable In a Phase III trial, estrogen-receptor positive breast cancer patients harboring a PIK3CA mutation demonstrated a greater benefit when treated with Femara (letrozole) compared to Nolvadex (tamoxifen) (PMID: 29902286; NCT00004205). 29902286

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05601700 Phase III Carboplatin + Paclitaxel Letrozole Letrozole for Estrogen/Progesterone Receptor Positive Low-grade Serous Epithelial Ovarian Cancer (LEPRE Trial) (LEPRE) Recruiting ITA 0
NCT03306472 Phase II Letrozole + Megestrol acetate Letrozole A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer (PIONEER) Completed GBR 0
NCT05464810 Phase I Letrozole + Simvastatin Letrozole Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Recruiting USA 0
NCT01674140 Phase III Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3) Active, not recruiting USA 1
NCT05472792 Phase II Toremifene Exemestane Tamoxifen Letrozole Anastrozole Fulvestrant Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) (CAMERAN) Recruiting USA 0
NCT02918084 Phase III Exemestane Anastrozole Letrozole CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer (GIM10-CONSENT) Active, not recruiting ITA 0
NCT04568616 Phase II Letrozole Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI) (NAOMI) Recruiting USA 0
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Phase II Study of Everolimus Beyond Progression Terminated USA 0
NCT02764541 Phase II Palbociclib Palbociclib + Tamoxifen Letrozole Tamoxifen Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) Active, not recruiting USA 0
NCT01923168 Phase II Buparlisib + Letrozole Letrozole Alpelisib + Letrozole Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women Completed USA | ITA | ESP | DEU | CAN | BEL | AUT | AUS 9
NCT02296801 Phase II Palbociclib Letrozole A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer Completed USA | GBR | CAN 0
NCT03962647 Phase I Letrozole A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer Active, not recruiting USA 0
NCT05649956 Phase II Letrozole Letrozole in Uterine Leiomyosarcoma Recruiting USA 0
NCT04886531 Phase II Anastrozole + Neratinib + Trastuzumab Letrozole + Neratinib + Trastuzumab Neratinib Anastrozole + Neratinib Letrozole + Neratinib Letrozole Anastrozole Anastrozole + Trastuzumab Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers Recruiting USA 0
NCT00651976 Phase I Letrozole Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery Terminated USA 0
NCT01035099 Phase I Letrozole RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF Completed USA 0
NCT04111978 Phase III Letrozole MAintenance Therapy With Aromatase Inhibitor in Epithelial Ovarian Cancer (MATAO) (MATAO) Recruiting DEU | AUT 1
NCT03458221 Phase II Itraconazole Everolimus Letrozole Bicalutamide Signal TrAnsduction Pathway Activity Analysis in OVarian cancER (STAPOVER) Recruiting 1
NCT06072781 Phase III Paclitaxel Pegylated liposomal doxorubicin Defactinib + RO5126766 Topotecan Anastrozole Letrozole A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (RAMP 301) Recruiting USA | AUS 0
NCT02010021 Phase I Letrozole Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer. Completed USA 0
NCT01491737 Phase II Anastrozole Letrozole Trastuzumab Pertuzumab + Trastuzumab A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN) Completed USA | ITA | GBR | FRA | ESP 3
NCT01272037 Phase III Anastrozole Letrozole Tamoxifen Exemestane Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Active, not recruiting USA | FRA | ESP | CAN 6
NCT03555877 Phase II Anastrozole Fulvestrant Fulvestrant + Ribociclib Letrozole Exemestane + Ribociclib Letrozole + Ribociclib Anastrozole + Ribociclib Exemestane Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer (AMICA) Completed DEU 0
NCT03820830 Phase III Anastrozole Exemestane Anastrozole + Palbociclib Letrozole Letrozole + Palbociclib Exemestane + Palbociclib Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (POLAR) Recruiting ITA | FRA | ESP | AUT 2
NCT02188745 Phase II Exemestane Estradiol Anastrozole Letrozole ER Reactivation Therapy for Breast Cancer (POLLY) Active, not recruiting USA 0
NCT04961996 Phase III Exemestane Giredestrant Letrozole Anastrozole A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 44
NCT01797523 Phase II Letrozole Everolimus Metformin RAD/Letrozole/Metformin Active, not recruiting USA 0
NCT00461773 Phase II Letrozole Bevacizumab Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast Cancer Terminated USA 0
NCT01958021 Phase III Letrozole + Ribociclib Letrozole Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 19
NCT05150652 Phase II Exemestane Tamoxifen Letrozole Anastrozole Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer Recruiting USA 0
NCT05447910 Phase II Letrozole Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer Recruiting USA 0
NCT02040857 Phase II Exemestane Palbociclib Tamoxifen Letrozole Anastrozole A Study of Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer Completed USA 0
NCT03747042 Phase I Letrozole Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer Active, not recruiting USA 0
NCT03122197 Phase I Letrozole Study of Letrozole in Recurrent Gliomas Recruiting USA 0
NCT02095184 Phase 0 Anastrozole Letrozole GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients Recruiting USA 0
NCT02753686 Phase I Tamoxifen Exemestane Fulvestrant Letrozole Anastrozole Everolimus + Exemestane Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy (Treat ER+ight) Completed CAN 0
NCT03778931 Phase III Letrozole Exemestane Elacestrant Fulvestrant Anastrozole Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD) Active, not recruiting USA | ITA | GBR | FRA | ESP | CAN | BEL | AUT | AUS 8
NCT05712941 Phase III G1T38 + Letrozole Letrozole Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer Withdrawn 0
NCT03906669 Phase II Letrozole Tamoxifen A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer. (WinPro) Recruiting AUS 0
NCT05101564 Phase II Amcenestrant Alpelisib Infigratinib Tamoxifen Letrozole Amcenestrant + Letrozole Umbrella Trial Testing Integrative Subtype-Targeted Therapeutics in HR+ /HER2-Negative Breast Cancer Recruiting USA 0
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Withdrawn 0
NCT01160211 Phase III Lapatinib + Trastuzumab Letrozole Anastrozole Lapatinib Trastuzumab Exemestane A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer Completed USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 29
NCT04289805 FDA approved Letrozole Controlled Ovarian Stimulation in Newly Diagnosed Breast Cancer PatiEnts (fAMHOPE) (fAMHOPE) Recruiting ITA | FRA | BEL 0
NCT02684032 Phase I Letrozole Fulvestrant Gedatolisib + Palbociclib A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer Completed USA 0
NCT03238703 FDA approved Tamoxifen Exemestane Toremifene Anastrozole Letrozole Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer Withdrawn USA 0
NCT04129216 Phase II Letrozole Tamoxifen Exemestane The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer Active, not recruiting USA 0
NCT05183828 FDA approved Letrozole Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer Suspended USA 0
NCT05512364 Phase III Letrozole Anastrozole Exemestane Elacestrant Tamoxifen Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) (TREAT ctDNA) Recruiting ITA | FRA | DEU | BEL 1
NCT03219476 Phase II Anastrozole Letrozole Tamoxifen Exemestane Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer Active, not recruiting USA 0
NCT06179303 Phase II Tamoxifen Exemestane Abemaciclib Fulvestrant Letrozole Anastrozole Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer Not yet recruiting USA 0
NCT05952557 Phase III Tamoxifen Abemaciclib + Tamoxifen Abemaciclib + Exemestane Abemaciclib + Camizestrant Abemaciclib + Letrozole Abemaciclib + Anastrozole Exemestane Anastrozole Letrozole An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (CAMBRIA-2) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 33
NCT02619669 Phase I Sapanisertib Letrozole Neoadjuvant Run-In Study With TAK-228 (MLN0128) Followed by Letrozole/TAK-228 (MLN0128) in Women With High-Risk ER+/HER2- Breast Cancer Withdrawn USA 0
NCT01296555 Phase I Fulvestrant Taselisib Letrozole A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors And in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer Completed USA | FRA | ESP | CAN 0
NCT04614194 Phase II Letrozole Abemaciclib + Letrozole Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib Recruiting USA 0
NCT03355157 FDA approved Exemestane + Palbociclib Tamoxifen Paclitaxel Exemestane Capecitabine Palbociclib + Tamoxifen Epirubicin Vinorelbine Fulvestrant + Palbociclib Fulvestrant Letrozole Letrozole + Palbociclib A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study). (PADMA) Unknown status DEU 0
NCT04134598 Phase III Tamoxifen Letrozole Anastrozole Exemestane ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged >=70 Years Early Stage Breast Cancer (EUROPA) Recruiting ITA 0
NCT03809988 Phase II Fulvestrant Fulvestrant + Palbociclib Letrozole Letrozole + Palbociclib PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) Completed ITA | GBR | FRA | ESP | DEU 1
NCT04095364 Phase III Carboplatin + Letrozole + Paclitaxel Letrozole Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian or Primary Peritoneal Cancer Recruiting USA | CAN 2
NCT01669343 Phase I Letrozole Aromatase Inhibitor Host Factors Study Completed CAN 0
NCT02689921 Phase II Anastrozole Letrozole Leuprolide Pertuzumab + Trastuzumab Exemestane NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer (NEOADAPT) Unknown status USA 0
NCT06001762 Phase II Tamoxifen Exemestane Abemaciclib Anastrozole Letrozole TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer Recruiting USA 0
NCT05514054 Phase III Letrozole Anastrozole Exemestane Tamoxifen LY3484356 A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 22
NCT05774951 Phase III Tamoxifen Exemestane Anastrozole Letrozole Camizestrant A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy (CAMBRIA-1) Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 29
NCT04272801 Phase II Anastrozole Letrozole Tamoxifen Exemestane Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer (POWER) Active, not recruiting USA 0
NCT02450175 Phase I Letrozole Everolimus Etiology of the Platelet-Cancer Metastatic Pathway - A Study of Inflammatory Markers, Platelet Characteristics and Metastatic Surrogates in Cancer Patients and Controls Unknown status USA 0
NCT06016738 Phase III Fulvestrant Letrozole Anastrozole Palazestrant Exemestane OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01) Recruiting USA | AUS 4
NCT02947685 Phase III Fulvestrant Pertuzumab Letrozole Anastrozole Exemestane Palbociclib Trastuzumab Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) Active, not recruiting USA | ITA | FRA | ESP | DEU | AUS 2
NCT04191382 Phase II Letrozole Amcenestrant Phase 2 Window Study of SAR439859 Versus Letrozole in ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4) Terminated USA | ITA | FRA | ESP | BEL 4
NCT02115048 Phase II Afatinib Letrozole Clinical Study for the Treatment of Breast Cancer the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone Terminated USA | ESP 2


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