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

Letrozole and RAD001 With Advanced or Recurrent Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Endometrial Cancer

Interventions: Drug: Letrozole
Drug: RAD001 (Everolimus)

First Posted Date: 2010-02-12

Last Posted Date: 2024-10-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 42

Registration Number: NCT01068249

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Morristown Memorial Hospital, Women's Cancer Center, Morristown, New Jersey, United States

Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Letrozole

First Posted Date: 2010-02-08

Last Posted Date: 2024-05-08

Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Target Recruit Count: 2056

Registration Number: NCT01064635

Locations: 🇮🇹
Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women

Phase 4

Completed

Conditions: Fertility

Interventions: Drug: Letrozole

First Posted Date: 2010-01-12

Last Posted Date: 2016-11-28

Lead Sponsor: University of Saskatchewan

Target Recruit Count: 41

Registration Number: NCT01046578

Locations: 🇨🇦
Royal University Hospital, Saskatoon, Saskatchewan, Canada

RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF

Phase 4

Completed

Conditions: Infertility
Breast Cancer

Interventions: Drug: Letrozole

First Posted Date: 2009-12-18

Last Posted Date: 2022-12-13

Lead Sponsor: Weill Medical College of Cornell University

Target Recruit Count: 41

Registration Number: NCT01035099

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States

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

Phase 2

Withdrawn

Conditions: Breast Cancer

Interventions: Drug: IGF-1R inhibitor OSI-906
Drug: erlotinib hydrochloride
Drug: goserelin
Drug: letrozole

First Posted Date: 2009-11-13

Last Posted Date: 2013-05-23

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Registration Number: NCT01013506

Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Lapatinib
Drug: Letrozole
Drug: Trastuzumab

First Posted Date: 2009-10-22

Last Posted Date: 2023-06-18

Lead Sponsor: Baylor Breast Care Center

Target Recruit Count: 128

Registration Number: NCT00999804

Locations: 🇺🇸
Baylor College of Medicine Lester and Sue Smith Breast Center, Houston, Texas, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Alabama - Birmingham, Birmingham, Alabama, United States

and more 5 locations

Letrozole as a Treatment of Endometrial Cancer

Not Applicable

Completed

Conditions: Endometrial Carcinoma

Interventions: Drug: Letrozole

First Posted Date: 2009-10-19

Last Posted Date: 2017-05-30

Lead Sponsor: University of California, Davis

Target Recruit Count: 43

Registration Number: NCT00997373

Locations: 🇺🇸
University of California Davis, Sacramento, California, United States
🇺🇸
University of California, Davis, Sacramento, California, United States

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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: cyclophosphamide
Drug: letrozole
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil

First Posted Date: 2009-08-21

Last Posted Date: 2013-08-12

Lead Sponsor: Imperial College London

Target Recruit Count: 756

Registration Number: NCT00963729

Locations: 🇬🇧
St. Mary's Hospital, London, England, United Kingdom
🇰🇷
Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of
🇬🇧
West Middlesex University Hospital, Isleworth, England, United Kingdom

and more 2 locations