Letrozole
Hormone Receptor-Positive Breast Cancer
Explore 112 assets in Hormone Receptor-Positive Breast Cancer →Floatz Rating
BB69/100
Confidence
Indicative
Sponsor
Universitaire Ziekenhuizen KU Leuven
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
61High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07492641CT.gov BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease | — | Recruiting | — | — | — |
NCT07195227CT.gov Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer | — | Recruiting | — | — | — |
NCT07581834CT.gov Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study | — | Recruiting | — | — | — |
NCT06998407CT.gov ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT07061717CT.gov Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer | — | Not Yet Recruiting | — | — | — |
NCT07285382CT.gov Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer | — | Recruiting | — | — | — |
NCT07029399CT.gov A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors | — | Recruiting | — | — | — |
NCT06625775CT.gov Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT06179303CT.gov Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer | — | Recruiting | — | — | — |
NCT06253195CT.gov BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors | — | Completed | — | — | — |
Show 18 more trialsShow fewer
NCT06120283CT.gov BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT05867251CT.gov Study of AVZO-021 in Patients With Advanced Solid Tumors | — | Recruiting | — | — | — |
NCT06805812CT.gov Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study | — | Recruiting | — | — | — |
NCT05286437CT.gov Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole | — | Recruiting | — | — | — |
NCT05452213CT.gov Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients | — | Recruiting | — | — | — |
NCT05766410CT.gov A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC | — | Recruiting | — | — | — |
NCT05467891CT.gov Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer | — | Recruiting | — | — | — |
NCT05362760CT.gov Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management | — | Recruiting | — | — | — |
NCT05252416CT.gov (VELA) Study of BLU-222 in Advanced Solid Tumors | — | Terminated | — | — | — |
NCT06570031CT.gov ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer | — | Completed | — | — | — |
NCT04282031CT.gov A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer | — | Recruiting | — | — | — |
NCT04088110CT.gov Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer | — | Unknown | — | — | — |
NCT03477396CT.gov Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer | — | Completed | — | — | — |
NCT03294694CT.gov Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer | — | Terminated | — | — | — |
NCT02760030CT.gov Endocrine Therapy Fulvestrant & Palbociclib or Aromatase Inhibitor Therapy in Treating Older Patients With Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery | — | Completed | — | — | — |
NCT02152943CT.gov Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients | — | Completed | — | — | — |
NCT02035813CT.gov DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs). | — | Completed | — | — | — |
NCT01698918CT.gov Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Hormone Receptor-Positive Breast Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Letrozole (this asset) | Universitaire Ziekenhuizen KU Leuven | Approved | BB · 69 |
| Exemestane | Fujian Cancer Hospital | P4 | BBB |
| Everolimus | Ellipses Pharma | P4 | BBB |
| Anastrozole | University of Illinois at Chicago | P4 | BBB |
| Ribociclib | BeOne Medicines | P4 | BBB |
| Palbociclib | BeOne Medicines | P3 | BBB |
| Abemaciclib | BeOne Medicines | P4 | BBB |
| Capecitabine | Kristina A. Fanucci | P4 | BBB |
| Elacestrant | West German Study Group | P3 | BB |
+42 more in the Hormone Receptor-Positive Breast Cancer cohort
Other indications for Letrozole
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Infertility Disorder | — | P4 | BBB · 79 |
| Anovulation | — | P4 | BBB · 78 |
| Invasive Breast Carcinoma | — | P4 | BBB · 74 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Letrozole in Hormone Receptor-Positive Breast Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/letrozole-hormone-receptor-positive-breast-cancer
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