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

Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer

Phase 2

Conditions: Breast Cancer

Interventions: Drug: anastrozole
Drug: cyclophosphamide
Drug: exemestane
Drug: letrozole
Drug: methotrexate
Drug: prednisolone

First Posted Date: 2008-06-02

Last Posted Date: 2009-06-17

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 70

Registration Number: NCT00687648

Locations: 🇸🇬
National Cancer Centre - Singapore, Singapore, Singapore

Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

Phase 3

Conditions: Breast Cancer

Interventions: Drug: anastrozole
Drug: fulvestrant
Other: placebo
Drug: lapatinib ditosylate
Drug: exemestane
Drug: letrozole

First Posted Date: 2008-06-02

Last Posted Date: 2013-08-26

Lead Sponsor: Gruppo Italiano Mammella (GIM)

Target Recruit Count: 396

Registration Number: NCT00688194

Locations: 🇮🇹
Federico II University Medical School, Naples, Italy

Cognitive Function in Older Women With Stage I, Stage II, or Stage III Breast Cancer Receiving Hormone Therapy

Completed

Conditions: Breast Cancer

Interventions: Drug: anastrozole
Drug: letrozole
Other: questionnaire administration
Procedure: cognitive assessment
Procedure: psychosocial assessment and care

First Posted Date: 2008-05-21

Last Posted Date: 2011-12-02

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 72

Registration Number: NCT00681928

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States

Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation

Phase 3

Completed

Conditions: brca1 Mutation Carrier
Breast Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
brca2 Mutation Carrier

Interventions: Drug: Placebo
Drug: letrozole

First Posted Date: 2008-05-07

Last Posted Date: 2024-07-01

Lead Sponsor: UNICANCER

Target Recruit Count: 170

Registration Number: NCT00673335

Locations: 🇫🇷
Hopital Arnaud de Villeneuve, Montpellier, France
🇫🇷
Centre Hospitalier General de Niort, Niort, France
🇫🇷
Centre Catherine de Sienne, Nantes, France

and more 20 locations

Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery

Early Phase 1

Terminated

Conditions: Breast Cancer

Interventions: Drug: letrozole
Other: Blood Collection
Procedure: biopsy/lumpectomy/mastectomy

First Posted Date: 2008-04-03

Last Posted Date: 2018-10-15

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 213

Registration Number: NCT00651976

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, One Hundred Oaks, Nashville, Tennessee, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

and more 2 locations

Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

Phase 1

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: Sorafenib
Drug: Letrozole

First Posted Date: 2008-03-13

Last Posted Date: 2023-11-09

Lead Sponsor: Rutgers, The State University of New Jersey

Target Recruit Count: 52

Registration Number: NCT00634634

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Cooper Hospital/University Medical Center, Voorhees, New Jersey, United States

and more 1 locations

Femara (Letrozole) Versus Placebo for Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2

Withdrawn

Conditions: Peritoneal Cancer
Fallopian Tube Cancer
Ovarian Cancer

Interventions: Drug: Placebo
Drug: Femara

First Posted Date: 2008-03-13

Last Posted Date: 2016-04-20

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT00634894

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: erlotinib hydrochloride
Drug: letrozole
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

First Posted Date: 2008-02-11

Last Posted Date: 2012-08-09

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 48

Registration Number: NCT00611715

Locations: 🇺🇸
Jackson-Madison County Hospital, Jackson, Tennessee, United States
🇺🇸
The Jones Clinic - Germantown, Germantown, Tennessee, United States
🇺🇸
Tennessee Cancer Specialists, Knoxville, Tennessee, United States

and more 6 locations

Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility

Phase 3

Completed

Conditions: Infertility

Interventions: Drug: Letrozole
Drug: Clomiphene citrate

First Posted Date: 2008-02-07

Last Posted Date: 2008-02-07

Lead Sponsor: Sun Pharmaceutical Industries Limited

Target Recruit Count: 55

Registration Number: NCT00610077

Locations: 🇮🇳
IVF Centre, Chembur,, Mumbai-, Maharashtra, India

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Phase 3

Active, not recruiting

Conditions: Stage III Breast Cancer AJCC v6
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7
Invasive Breast Carcinoma

Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate

First Posted Date: 2008-01-28

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 394

Registration Number: NCT00601900

Locations: 🇺🇸
Northside Hospital, Atlanta, Georgia, United States
🇺🇸
Augusta University Medical Center, Augusta, Georgia, United States
🇺🇸
WellStar Cobb Hospital, Austell, Georgia, United States

and more 517 locations

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