Letrozole

Generic Name
Letrozole
Brand Names
Femara, Kisqali Femara Co-pack
Drug Type
Small Molecule
Chemical Formula
C17H11N5
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
-

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-06-07
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
28
Registration Number
NCT01367626
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Bioequivalency Study of Letrozole 2.5 mg Tablets Under Fasted Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-06-07
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
28
Registration Number
NCT01367652
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

Letrozole for Lymphangioleiomyomatosis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-05-12
Last Posted Date
2024-04-17
Lead Sponsor
University of Cincinnati
Target Recruit Count
17
Registration Number
NCT01353209
Locations
🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

🇺🇸

Emory University School of Medicine, Atlanta, Georgia, United States

🇺🇸

Stanford University Medical Center, Stanford, California, United States

and more 6 locations

Dosage Optimization for Letrozole Treatment

Phase 4
Completed
Conditions
First Posted Date
2011-03-16
Last Posted Date
2011-03-28
Lead Sponsor
Bushehr University of Medical Science
Target Recruit Count
44
Registration Number
NCT01315912
Locations
🇮🇷

Bushehr university of medical science, Bushehr, Iran, Islamic Republic of

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

First Posted Date
2011-02-15
Last Posted Date
2024-07-31
Lead Sponsor
Genentech, Inc.
Target Recruit Count
674
Registration Number
NCT01296555
Locations
🇺🇸

Univ of Chicago, Chicago, Illinois, United States

🇺🇸

Mary Crowley Cancer Rsch Ctr, Dallas, Texas, United States

🇺🇸

Baylor Sammons Cancer Center, Dallas, Texas, United States

and more 28 locations

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

First Posted Date
2011-01-07
Last Posted Date
2024-12-19
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
5018
Registration Number
NCT01272037
Locations
🇺🇸

Mills-Peninsula Medical Center, Burlingame, California, United States

🇺🇸

Dublin Hematology Oncology Care PC, Dublin, Georgia, United States

🇺🇸

Piedmont Fayette Hospital, Fayetteville, Georgia, United States

and more 1565 locations

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

First Posted Date
2010-11-25
Last Posted Date
2016-07-25
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Target Recruit Count
72
Registration Number
NCT01248494
Locations
🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

🇺🇸

Massachusetts General Hospital, Dana Farber Cancer Center, Boston, Massachusetts, United States

🇺🇸

University of Alabama, Birmingham, Alabama, United States

and more 3 locations

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

First Posted Date
2010-11-01
Last Posted Date
2021-03-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
72
Registration Number
NCT01231659
Locations
🇮🇱

Novartis Investigative Site, Tel Aviv, Israel

Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-10-20
Last Posted Date
2020-08-11
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
77
Registration Number
NCT01225172
Locations
🇺🇸

Oncology Care Associates, P.A., Wheaton, Maryland, United States

🇺🇸

Presbyterian Hospital Cancer Research, Charlotte, North Carolina, United States

🇺🇸

University Of Virginia Health System, Charlottesville, Virginia, United States

and more 13 locations
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