Drug · Small Molecule
Letrozole
CI-DRUG-00000339Explore in graph →NCIt C1527 CHEMBL1444 CIViC Approved
Regulatory
Approvals (51)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | Malignant Breast Neoplasm | First and second-line treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer. | approved | Jul 25, 1997 | openfda |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated yesterdaySource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 113 | 58 | 110 | 409 | 51 | CA, US | Jul 25, 1997 | 1998-03 |
| Malignant Breast Neoplasm | Approved | Phase 4 | 59 | 27 | 64 | 235 | 3 | US | Jul 25, 1997 | 1998-03 |
| Malignant Uterine Corpus Neoplasm | Phase4 | Phase 4 | 9 | 6 | 2 | 19 | 0 | — | — | Jan 19, 2000 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 7 | 5 | 5 | 17 |
Curated evidence
Clinical evidence (6)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 19786658
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ERBB2 Amplification1 | ||||||||
| Lapatinib + Letrozole | ||||||||
Clinical trials
Trials with this intervention (429)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT00499681 | PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE | terminated | Phase 2 | 6 | Vanderbilt-Ingram Cancer CenterOTHER | 1 | Aug 10, 2012 | clinicaltrials |
| NCT00611715 | Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer. | terminated |