Therapy Detail

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Therapy Name Letrozole
Synonyms
Therapy Description

Femara (letrozole) is an aromatase inhibitor, which inhibits estrogen synthesis (NCI Drug Dictionary). Femara (letrozole) 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
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 Unknown status USA | CAN 1
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
NCT04272801 Phase I Anastrozole Letrozole Tamoxifen Exemestane Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer (Breast52) 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
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 Active, not recruiting USA 0
NCT01797523 Phase II Letrozole Everolimus Metformin RAD/Letrozole/Metformin Active, not recruiting USA 0
NCT03747042 Phase I Letrozole Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer 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) Active, not recruiting CAN 0
NCT04568616 Phase II Letrozole Neoadjuvant ArOMatase Inhibitor Therapy for ER+ Breast Cancer (NAOMI) (NAOMI) Not yet recruiting USA 0
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 3
NCT03962647 Phase I Letrozole A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer Recruiting USA 0
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) Recruiting USA 6
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 Active, not recruiting USA 0
NCT02010021 Phase I Letrozole Presurgical Treatment With Letrozole in Patients With Early-stage Breast Cancer. Completed USA 0
NCT04614194 Phase II Letrozole Abemaciclib + Letrozole Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib Not yet recruiting 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 7
NCT02764541 Phase II Palbociclib Palbociclib + Tamoxifen Letrozole Tamoxifen Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS) Active, not recruiting USA 0
NCT02188745 Phase II Exemestane Estradiol Anastrozole Letrozole ER Reactivation Therapy for Breast Cancer (POLLY) Recruiting USA 0
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
NCT01674140 Phase III Goserelin Anastrozole Letrozole Leuprolide Everolimus Tamoxifen Exemestane S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer Active, not recruiting USA 1
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 Active, not recruiting USA | CAN 2
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
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 | CAN 8
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 Active, not recruiting USA | CAN 36
NCT04129216 Phase II Letrozole Tamoxifen Exemestane The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer Recruiting USA 0
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 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
NCT01958021 Phase III Letrozole + Ribociclib Letrozole Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) (MONALEESA-2) Active, not recruiting USA | CAN 27
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 | CAN 15
NCT01669343 Phase I Letrozole Aromatase Inhibitor Host Factors Study Unknown status CAN 0
NCT03122197 Phase I Letrozole Study of Letrozole in Recurrent Gliomas Recruiting USA 0
NCT04191382 Phase II Letrozole SAR439859 Phase 2 Window Study of SAR439859 Versus Letrozole in ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4) Active, not recruiting USA 9
NCT03238703 FDA approved Tamoxifen Exemestane Toremifene Anastrozole Letrozole Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer Withdrawn USA 0
NCT02095184 Phase 0 Anastrozole Letrozole GCC 1366: Anti-Proliferative Response to NeoAdjuvant AIs in Overweight and Obese Patients 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
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 | CAN 15
NCT02269670 Phase II Tamoxifen Everolimus Megestrol acetate Letrozole Fulvestrant Anastrozole Phase II Study of Everolimus Beyond Progression Active, not recruiting USA 0


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