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

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer

Phase 2

Active, not recruiting

Conditions: Advanced, Persistent, or Recurrent Endometrial Cancer

Interventions: Drug: Tamoxifen
Drug: Everolimus
Drug: Letrozole
Drug: Medroxyprogesterone Acetate

First Posted Date: 2014-08-29

Last Posted Date: 2024-01-03

Lead Sponsor: GOG Foundation

Target Recruit Count: 74

Registration Number: NCT02228681

Locations: 🇺🇸
Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
🇺🇸
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

and more 23 locations

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

Phase 2

Active, not recruiting

Conditions: Tubular Breast Cancer
Inflammatory Breast Cancer
Invasive Ductal Breast Cancer
Mucinous Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Cisplatin
Drug: Gonadotropin-releasing hormone agonist
Drug: Letrozole

First Posted Date: 2014-08-21

Last Posted Date: 2023-08-29

Lead Sponsor: RenJi Hospital

Target Recruit Count: 250

Registration Number: NCT02221999

Locations: 🇨🇳
Department of Thyroid and Breast Gland Surgery,Shenzhen Longgang Central Hospital, Shenzhen, Guangdong, China
🇨🇳
Zhongshan Hospital, Shanghai, Shanghai, China
🇨🇳
The second people's hospital of Kunshan city, Kunshan, Jiangsu, China

and more 9 locations

Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women

Phase 2

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab
Drug: Letrozole

First Posted Date: 2014-08-12

Last Posted Date: 2018-02-15

Lead Sponsor: Gangnam Severance Hospital

Target Recruit Count: 132

Registration Number: NCT02214004

Locations: 🇰🇷
Hallym University Sacred Heart Hospital, Anyang, Korea, Republic of
🇰🇷
Inje University Pusan Paik Hospital, Busan, Korea, Republic of
🇰🇷
Gangnam Severance Hospital, Seoul, Korea, Republic of

and more 11 locations

ER Reactivation Therapy for Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: 17B-estradiol
Drug: Letrozole
Drug: Anastrozole
Drug: Exemestane

First Posted Date: 2014-07-14

Last Posted Date: 2024-07-17

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 19

Registration Number: NCT02188745

Locations: 🇺🇸
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
🇺🇸
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
🇺🇸
Baystate Medical Center, Springfield, Massachusetts, United States

Comparison of Treatment Modalities in Poor Responders Undergoing IVF

Not Applicable

Completed

Conditions: Poor Responders

Interventions: Drug: human menopausal gonadotropin (hMG)
Drug: Letrozole

First Posted Date: 2014-06-09

Last Posted Date: 2016-01-08

Lead Sponsor: Ercan Bastu

Target Recruit Count: 80

Registration Number: NCT02158689

Locations: 🇹🇷
Department of Obstetrics and Gynecology, Istanbul University School of Medicine, Istanbul, Turkey

Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.

Phase 1

Completed

Conditions: Advanced or Metastatic Breast Cancer

Interventions: Drug: LEE011
Drug: Buparlisib
Drug: Letrozole

First Posted Date: 2014-06-03

Last Posted Date: 2020-12-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 13

Registration Number: NCT02154776

Locations: 🇺🇸
Horizon Oncology Center SC, Lafayette, Indiana, United States
🇺🇸
Medical University of South Carolina SC, Charleston, South Carolina, United States
🇺🇸
South Texas Accelerated Research Therapeutics SC, San Antonio, Texas, United States

and more 3 locations

Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients

Phase 1

Completed

Conditions: Advanced Malignant Solid Neoplasm
Estrogen Receptor Positive
HER2/Neu Positive
Postmenopausal
Premenopausal
Refractory Breast Carcinoma
Recurrent Breast Carcinoma
Progesterone Receptor Positive
Refractory Hormone Receptor Positive Breast Carcinoma
Stage IIIA Breast Cancer AJCC v7

Interventions: Drug: Everolimus
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Biological: Trastuzumab

First Posted Date: 2014-06-02

Last Posted Date: 2020-12-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 37

Registration Number: NCT02152943

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
MD Anderson in Katy, Houston, Texas, United States
🇺🇸
MD Anderson in Sugar Land, Sugar Land, Texas, United States

and more 2 locations

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Conditions: Advanced Breast Cancer (Female)

First Posted Date: 2014-05-20

Last Posted Date: 2018-12-21

Lead Sponsor: Pfizer

Registration Number: NCT02142868

Locations: 🇺🇸
Presence Saint Joseph Hospital, Chicago, Illinois, United States
🇺🇸
Presence Infusion Care - Skokie, Skokie, Illinois, United States
🇺🇸
SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building, Baltimore, Maryland, United States

and more 42 locations

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Phase 4

Completed

Conditions: Short Stature

Interventions: Drug: Letrozole
Drug: Anastrozole

First Posted Date: 2014-05-14

Last Posted Date: 2021-07-15

Lead Sponsor: Stanford University

Target Recruit Count: 79

Registration Number: NCT02137538

Locations: 🇺🇸
Lucile Packard Children's Hospital, Palo Alto, California, United States

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Phase 2

Terminated

Conditions: Breast Neoplasms

Interventions: Drug: Letrozole
Drug: Afatinib

First Posted Date: 2014-04-15

Last Posted Date: 2019-12-26

Lead Sponsor: Translational Research in Oncology

Target Recruit Count: 44

Registration Number: NCT02115048

Locations: 🇧🇦
University Hospital Clinical Center Banja Luka, Oncology Clinic, Banja Luka, Bosnia and Herzegovina
🇺🇸
DBA Torrance Memorial Physician Network/Cancer Care Associates, Redondo Beach, California, United States
🇪🇸
Hospital Clínico Universitario Virgen de La Arrixaca, Murcia, Spain

and more 23 locations

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