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

Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Cancer

Interventions: Drug: Letrozole
Drug: Palbociclib/placebo

First Posted Date: 2016-04-06

Last Posted Date: 2023-02-15

Lead Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

Target Recruit Count: 78

Registration Number: NCT02730429

Locations: 🇩🇰
NSGO-CTU, Copenhagen, Sjaelland, Denmark

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Letrozole
Drug: Placebo
Drug: Ribociclib

First Posted Date: 2016-03-18

Last Posted Date: 2022-09-27

Lead Sponsor: Qamar Khan

Target Recruit Count: 121

Registration Number: NCT02712723

Locations: 🇺🇸
University of Kansas Cancer Center - Overland Park, Overland Park, Kansas, United States
🇺🇸
University of Kansas Cancer Center - West, Kansas City, Kansas, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

and more 10 locations

Administration of Single High Dose Letrozole for Ovulation Induction

Phase 4

Completed

Conditions: Anovulation

Interventions: Drug: Letrozole

First Posted Date: 2016-03-09

Last Posted Date: 2021-09-17

Lead Sponsor: Mount Sinai Hospital, Canada

Target Recruit Count: 36

Registration Number: NCT02703649

Locations: 🇨🇦
Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada
🇨🇦
TRIO Fertility, Toronto, Ontario, Canada

Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers

Not Applicable

Completed

Conditions: Breast Cancer

First Posted Date: 2016-03-08

Last Posted Date: 2021-08-06

Lead Sponsor: NHS Tayside

Target Recruit Count: 31

Registration Number: NCT02701348

Locations: 🇬🇧
Stefani Clinical Trials Unit, Ninewells Hospital and Medical School, Dundee, Angus, United Kingdom

NEOADjuvant Aromatase Inhibitor and Pertuzumab/Trastuzumab for Women With Breast Cancer

Phase 2

Conditions: Breast Neoplasms

Interventions: Drug: Exemestane
Drug: Letrozole
Drug: Anastrozole
Drug: Leuprolide Acetate
Drug: Pertuzumab
Drug: Trastuzumab

First Posted Date: 2016-02-24

Last Posted Date: 2018-09-28

Lead Sponsor: Midwestern Regional Medical Center

Target Recruit Count: 7

Registration Number: NCT02689921

Locations: 🇺🇸
Cancer Treatment Centers of America at Midwestern Regional Medical Center, Zion, Illinois, United States
🇺🇸
Southeastern Regional Medical Center, Newnan, Georgia, United States

The Letrozole Administration During Luteal Phase

Phase 3

Not yet recruiting

Conditions: Ovarian Hyperstimulation Syndrome

Interventions: Drug: Polygeline
Drug: Letrozole
Drug: Sodium Chloride
Drug: dexamethasone

First Posted Date: 2016-02-19

Last Posted Date: 2023-07-20

Lead Sponsor: The Affiliated Hospital of Inner Mongolia Medical University

Target Recruit Count: 50

Registration Number: NCT02686151

Locations: 🇨🇳
The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia, China

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

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Fulvestrant
Drug: Gedatolisib
Drug: Palbociclib
Drug: Letrozole

First Posted Date: 2016-02-17

Last Posted Date: 2022-07-27

Lead Sponsor: Celcuity Inc

Target Recruit Count: 141

Registration Number: NCT02684032

Locations: 🇺🇸
The Emory Clinic, Atlanta, Georgia, United States
🇺🇸
Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Karmanos Cancer Institute, Farmington Hills, Michigan, United States

and more 33 locations

Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer

Phase 4

Completed

Conditions: Breast Cancer

Interventions: Drug: Palbociclib
Drug: Letrozole

First Posted Date: 2016-02-10

Last Posted Date: 2022-07-27

Lead Sponsor: Pfizer

Target Recruit Count: 252

Registration Number: NCT02679755

Locations: 🇮🇳
HealthCare Global Enterprises Ltd., Bangalore, Karnataka, India
🇮🇳
Tata Memorial Centre, Tata Memorial Hospital, Mumbai, Maharashtra, India
🇮🇳
Shatabdi Hospital, Nashik, Maharashtra, India

and more 31 locations