306 completed, 107 unknown, 86 recruiting, 67 active not recruiting. 305 Phase 2, 165 Phase 3, 89 Phase 1, 72 Not applicable, 59 Phase 4.
Follow this drug Literature Review of Letrozole trials Research Report on Letrozole
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer GDC-4198, Fulvestrant, Letrozole - Advanced or Metastatic Breast Cancer | Phase 1 | Not yet recruiting | Genentech, Inc. | 165 | 2026-12-15 | 2026-10-09 |
| Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. Alpelisib, Fulvestrant, Trastuzumab - PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) | Phase 2 | Not yet recruiting | Novartis Pharmaceuticals | 51 | 2026-12-15 | 2026-09-18 |
| QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant Chemotherapy Iparomlimab and Tuvonralimab (QL1706), Aromatase Inhibitor (AI), CDK4/6 inhibitor - Breast Cancer | Phase 2 | Not yet recruiting | Hebei Medical University Fourth Hospital | 40 | 2026-10-01 | 2026-08-26 |
| Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer Fulvestaciclib, Trastuzumab, Pertuzumab - Breast Cancer, HER2-positive Breast Cancer | Phase 2 | Not yet recruiting | Fudan University | 240 | 2026-10-01 | 2026-07-21 |
| Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer Culmerciclib, Letrozole, Trastuzumab (TQB211) - Breast Cancer, HR Positive, HER2 Positive Breast Cancer | Phase 2 | Not yet recruiting | Shengjing Hospital | 33 | 2026-09-01 | 2026-08-31 |
| BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder Aromatase Inhibitors, Bupropion, GnRH agonist - Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder | Phase 1 / Phase 2 | Not yet recruiting | University of Illinois at Chicago | 100 | 2026-09-01 | 2026-08-24 |
| De-EscaLaTion of Aromatase Inhibitor Therapy: A Randomized Phase II Study of De-escalated Letrozole in Hormone Receptor-Positive Early Breast Cancer Letrozole - Brest Cancer ER+ and HER2 Negative | Phase 2 | Not yet recruiting | Montefiore Medical Center | 144 | 2026-09-01 | 2026-10-08 |
| 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 Anastrozole, Biospecimen Collection, Bone Scan - Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8 | Phase 3 | Recruiting | National Cancer Institute (NCI) | 1978 | 2026-08-10 | 2026-10-20 |
| Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone · Misoprostol + letrozole, misoprostol alone - Abortion Induced Complicated, Abortion | Phase 1 / Phase 2 | Not yet recruiting | Sohag University | 80 | 2026-08-01 | 2026-08-17 |
| A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer Letrozole SIE + Ribociclib + Oral placebo, Oral Femara® + Ribociclib + Injectable placebo - Advanced, Metastatic Breast Cancer | Phase 3 | Not yet recruiting | Rovi Pharmaceuticals Laboratories | 300 | 2026-08-01 | 2026-04-02 |
| Clinical Study of Local and Systemic Biological Impact of GLP1/GIP-Receptor Agonists in Patients With Breast Cancer: The CLARA Trial Tirzepatide, Letrozole (Aromatase Inhibitors) - Hormone-receptor-positive Breast Cancer, Early Breast Cancer | Phase 2 | Not yet recruiting | Universitaire Ziekenhuizen KU Leuven | 168 | 2026-08-01 | 2026-07-07 |
| Kumorixilib Plus Capecitabine and Letrozole for Neoadjuvant Treatment of HR-Positive HER2-Negative Breast Cancer Kumorixilib 180mg, Capecitabine 500mg, Letrozole 2.5mg - HR+/HER2- Breast Cancer, Breast Neoplasms | Phase 2 | Not yet recruiting | Fujian Cancer Hospital | 35 | 2026-06-30 | 2026-07-08 |
| Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors ERW316, Fulvestrant, Letrozole - Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors | Phase 1 / Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2026-06-30 | 2026-06-22 | |
| FET in Adenomyosis GnRH agonist downregulation, GnRH agonist and Letrozole - Adenomyosis | Not applicable | Not yet recruiting | Indira IVF Hospital Pvt Ltd | 700 | 2026-06-25 | 2026-01-26 |
| Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer. Letrozole - Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer | Phase 2 | Not yet recruiting | Cancer Care Hospital & Research Centre Foundation, Lahore | 126 | 2026-06-01 | 2026-02-20 |
| Letrozole Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy Methotrexate (drug), Letrozole 2.5Mg Tab - Ectopic Pregnancy | Phase 2 | Not yet recruiting | Kafrelsheikh University | 70 | 2026-06-01 | 2026-06-03 |
| Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer IEV407, Fulvestrant, Letrozole - Advanced HR+/HER2- Breast Cancer | Phase 1 | Recruiting | Novartis Pharmaceuticals | 194 | 2026-05-28 | 2026-10-20 |
| 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 BGB-43395, Letrozole, Abemaciclib - HR+/HER2- Breast Cancer | Phase 3 | Recruiting | BeOne Medicines | 1056 | 2026-05-22 | 2026-10-16 |
| Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome Metformin, Dapagliflozin, Dapagliflozin/Metformin - Polycystic Ovary | Phase 3 | Completed | Beni-Suef University | 200 | 2026-03-30 | 2026-06-02 |
| A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet - Advanced Unresectable or Metastatic Breast Cancer of Adults | Phase 1 / Phase 2 | Recruiting | Shandong Suncadia Medicine Co., Ltd. | 180 | 2026-03-27 | 2026-04-03 |
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Breast Neoplasms (382) · Polycystic Ovary Syndrome (43) · Infertility (35) · Neoplasm Metastasis (23) · Endometrial Neoplasms (22) · Ovarian Neoplasms (15) · Neoplasms (14) · Carcinoma, Intraductal, Noninfiltrating (9) · Infertility, Female (9) · Fallopian Tube Neoplasms (8) · Obesity (8) · Recurrence (8) · Breast Diseases (7) · Breast Neoplasms, Male (7) · Carcinoma, Ductal, Breast (7)
Novartis Pharmaceuticals (46) · Pfizer (21) · Fudan University (12) · M.D. Anderson Cancer Center (11) · Cairo University (10) · Dana-Farber Cancer Institute (10) · Assiut University (9) · Eli Lilly and Company (9) · Mayo Clinic (8) · University of Washington (8) · Vanderbilt-Ingram Cancer Center (8) · MedSIR (7) · National Cancer Institute (NCI) (7) · University of California, San Francisco (7) · Alliance for Clinical Trials in Oncology (6)
United States (276) · China (115) · France (77) · Spain (76) · Italy (69) · Germany (62) · Canada (58) · United Kingdom (57) · South Korea (54) · Egypt (50) · Belgium (47) · Australia (43) · Japan (39) · Taiwan (35) · Brazil (34)
Hannah Linden (4) · Ingrid Mayer, MD (4) · Carol J Fabian, MD (3) · Heping Zhang, PhD (3) · Nanette Santoro, MD (3) · Norman Wolmark, MD (3)
PMID 36165742, PMID 38979716, PMID 42334791, PMID 29522361, PMID 36800111, PMID 25524798, PMID 26354094, PMID 26413816, PMID 27264120, PMID 27402910, PMID 27557300, PMID 29102040, PMID 29778387, PMID 30032196, PMID 30053671, PMID 30085176, PMID 31127500, PMID 31276981, PMID 31305131, PMID 32164785, PMID 33149768, PMID 33190149, PMID 33486783, PMID 33769862, PMID 33853037, PMID 34158598, PMID 34180998, PMID 34792133, PMID 35125179, PMID 35321427, PMID 36861085, PMID 37182538, PMID 37673211, PMID 37699851, PMID 38107828, PMID 38470447, PMID 39672366, PMID 40017004, PMID 10076721, PMID 10655301, PMID 11937133, PMID 12490681, PMID 12804433, PMID 12954578, PMID 14551341, PMID 15217999, PMID 15304161, PMID 15894097, PMID 15911866, PMID 16009161
2023 (9), 2016 (8), 2017 (8), 2019 (6), 2025 (6), 2014 (5), P30CA015083 (5), 2015 (4), 2005 (3), 2008 (3), P30CA015704 (3), U10CA180868 (3), 2004 (2), 2009 (2), 2018 (2)