Letrozole

Generic Name: Letrozole

Brand Names: Femara, Kisqali Femara Co-pack

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₁N_₅

CAS Number: 112809-51-5

Unique Ingredient Identifier: 7LKK855W8I

Background: Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor first described in the literature in 1990. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.

Letrozole was granted FDA approval on 25 July 1997.

Indication: Letrozole is indicated to treat postmenopausal women with hormone receptor (HR) positive early breast cancer, postmenopausal women with early breast cancer who have periviously been treated with tamoxifen, and postmenopausal women with HR+ or unknown advanced breast cancer. Letrozole, given with ribociclib, is indicated to treat pre, peri, and postmenopausal women with HR+ and human epidermal growth factor 2 (HER2) negative advanced or metastatic breast cancer.

Associated Conditions: Advanced Breast Cancer, Anovulatory cycle, Epithelial Ovarian Cancer, HR+, HER2-, Advanced Breast Cancer, Stage I Breast Cancer, Metastatic HR + HER2 - breast cancer

Associated Therapies: -

Clinical Trials

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

Phase 3

Active, not recruiting

Conditions: Estrogen Receptor Positive Breast Cancer
HER-2 Positive Breast Cancer

Interventions: Drug: palbociclib
Drug: trastuzumab
Drug: Anastrozole
Drug: pertuzumab
Drug: letrozole
Drug: Fulvestrant
Drug: Exemestane

First Posted Date: 2016-10-28

Last Posted Date: 2024-06-17

Lead Sponsor: Alliance Foundation Trials, LLC.

Target Recruit Count: 496

Registration Number: NCT02947685

Locations: 🇺🇸
University of Maryland - Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States

and more 115 locations

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

Phase 2

Completed

Conditions: Infertility

Interventions: Drug: Placebo
Drug: Letrozole

First Posted Date: 2016-10-27

Last Posted Date: 2019-07-08

Lead Sponsor: Sven O. Skouby

Target Recruit Count: 129

Registration Number: NCT02946684

Locations: 🇩🇰
Department of Fertility, Juliane Marie Centeret, Copenhagen, Capitol Region, Denmark
🇩🇰
Clinic of Fertility, Hvidovre Hospital, Hvidovre, Capitol Region, Denmark
🇩🇰
Clinic of Fertility, Holbæk Hospital, Holbæk, Region Of Zealand, Denmark

and more 1 locations

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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Ribociclib
Drug: Letrozole
Drug: Goserelin
Drug: Leuprolide

First Posted Date: 2016-10-21

Last Posted Date: 2023-10-24

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 3246

Registration Number: NCT02941926

Locations: 🇺🇸
Ventura County Hematology and Oncology, Oxnard, California, United States
🇺🇸
Mid Florida Hematology and Onc Ctr, Orange, Florida, United States
🇺🇸
Hope Cancer Center of East Texas, Tyler, Texas, United States

and more 69 locations

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

Phase 2

Completed

Conditions: Infertility

Interventions: Drug: Placebo
Drug: Letrozole

First Posted Date: 2016-10-20

Last Posted Date: 2019-02-05

Lead Sponsor: Sven O. Skouby

Target Recruit Count: 33

Registration Number: NCT02939898

Locations: 🇩🇰
Unit of Reproductive Medicine, Herlev Hospital, Herlev, Capital Region, Denmark

Letrozole in Stimulated IVF Cycles

Phase 3

Completed

Conditions: Subfertility

Interventions: Drug: Letrozole

First Posted Date: 2016-09-23

Last Posted Date: 2023-05-10

Lead Sponsor: The University of Hong Kong

Target Recruit Count: 900

Registration Number: NCT02912988

Locations: 🇨🇳
Department of Obstetrics and Gynaecology, Hong Kong, Hong Kong, China
🇨🇳
Peking University Third Hospital, Beijing, China

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

Phase 2

Terminated

Conditions: Breast Cancer
Cancer of Breast
Breast Carcinoma

Interventions: Drug: Palbociclib
Drug: Letrozole
Biological: Trastuzumab
Drug: Goserelin
Procedure: Breast surgery
Procedure: Research tumor biopsy
Procedure: Research bone marrow (OPTIONAL)
Procedure: Research blood sample
Genetic: Research blood for germline DNA
Procedure: Blood for detection of circulating tumor cells

First Posted Date: 2016-09-20

Last Posted Date: 2021-09-29

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 26

Registration Number: NCT02907918

Locations: 🇺🇸
Mayo Clinic, Phoenix, Arizona, United States
🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States