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LETROZOLE
LETROZOLE is a Aromatase Inhibitor [EPC] drug. It is currently FDA-approved (first approved 1997) for Adjuvant treatment of early breast cancer, Extended adjuvant treatment of early breast cancer, First-line treatment of advanced breast cancer.
At a glance
| Generic name | LETROZOLE |
|---|---|
| Drug class | Aromatase Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1997 |
Approved indications
- Adjuvant treatment of early breast cancer
- Extended adjuvant treatment of early breast cancer
- First-line treatment of advanced breast cancer
- Second-line treatment of advanced breast cancer
Common side effects
- Arthralgia
- Hot flashes
- Flushing
- Asthenia
- Edema
- Headache
- Dizziness
- Hypercholesterolemia
- Increased sweating
- Bone pain
- Musculoskeletal pain
Serious adverse events
- Fractures
- Myocardial infarction
- Thromboembolic events
- Endometrial hyperplasia/cancer
- Transient ischemic attack (TIA)
Drug interactions
- Tamoxifen
- Cimetidine
- Warfarin
Key clinical trials
- A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (PHASE3)
- Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial (PHASE3)
- Letrozole After Tamoxifen in Treating Women With Breast Cancer (PHASE3)
- Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) (PHASE3)
- A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (PHASE1)
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (PHASE3)
- Myo-Inositol for Infertility in PCOS (NA)
- ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LETROZOLE CI brief — competitive landscape report
- LETROZOLE updates RSS · CI watch RSS
Frequently asked questions about LETROZOLE
What is LETROZOLE?
LETROZOLE is a Aromatase Inhibitor [EPC] drug, indicated for Adjuvant treatment of early breast cancer, Extended adjuvant treatment of early breast cancer, First-line treatment of advanced breast cancer.
What is LETROZOLE used for?
LETROZOLE is indicated for Adjuvant treatment of early breast cancer, Extended adjuvant treatment of early breast cancer, First-line treatment of advanced breast cancer, Second-line treatment of advanced breast cancer.
What drug class is LETROZOLE in?
LETROZOLE belongs to the Aromatase Inhibitor [EPC] class. See all Aromatase Inhibitor [EPC] drugs at /class/aromatase-inhibitor-epc.
When was LETROZOLE approved?
LETROZOLE was first approved on 1997.
What development phase is LETROZOLE in?
LETROZOLE is FDA-approved (marketed).
What are the side effects of LETROZOLE?
Common side effects of LETROZOLE include Arthralgia, Hot flashes, Flushing, Asthenia, Edema, Headache. Serious adverse events: Fractures, Myocardial infarction, Thromboembolic events, Endometrial hyperplasia/cancer.
Related
- Drug class: All Aromatase Inhibitor [EPC] drugs
- Indication: Drugs for Adjuvant treatment of early breast cancer
- Indication: Drugs for Extended adjuvant treatment of early breast cancer
- Indication: Drugs for First-line treatment of advanced breast cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing