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DRUG:

letrozole

i
Other names: CGP 20267, CGS 20267, CGS20267
Company:
Generic mfg.
Drug class:
Aromatase inhibitor
1d
RibOB: A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer (clinicaltrials.gov)
P=N/A, N=78, Active, not recruiting, Universitaire Ziekenhuizen KU Leuven | Trial completion date: Dec 2023 --> Jun 2024
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole
1d
TALES: Fertility Preservation Using Tamoxifen and Letrozole in Estrogen Sensitive Tumors Trial (clinicaltrials.gov)
P3, N=144, Recruiting, University of California, San Francisco | Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
Trial completion date • Trial primary completion date
|
tamoxifen • letrozole
2d
Enrollment open
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • AR (Androgen receptor) • HSD3B1 (Hydroxy-Delta-5-Steroid Dehydrogenase 3 Beta- And Steroid Delta-Isomerase 1)
|
HER-2 negative
|
letrozole
3d
The Effects of Short-term Preoperative Treatment With Hormonal Therapy on Gene Profiles in Breast Cancer (clinicaltrials.gov)
P2, N=30, Completed, Johns Hopkins University | Active, not recruiting --> Completed
Trial completion
|
ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • PGR positive
|
letrozole • exemestane • Soltamox (tamoxifen citrate)
6d
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia (clinicaltrials.gov)
P4, N=62, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2024 | Trial primary completion date: Dec 2025 --> May 2024
Trial completion • Trial completion date • Trial primary completion date • Combination therapy
|
letrozole • flutamide
8d
New P2 trial
|
letrozole • avutometinib (VS-6766) • defactinib (VS-6063)
11d
The effect of adipose-derived mesenchymal stem cell transplantation on ovarian mitochondrial dysfunction in letrozole-induced polycystic ovary syndrome in rats: the role of PI3K-AKT signaling pathway. (PubMed, J Ovarian Res)
This study demonstrated that the protective effects of MSC transplantation in regulating mitochondrial dynamics, promoting mitochondrial biogenesis, competing with redox status and inflammation response were mainly mediated through the PI3K-AKT pathway in the PCOS model.
Preclinical • Journal
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
|
letrozole • LY294002
14d
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
P1, N=11, Terminated, Kyowa Kirin Co., Ltd. | Phase classification: P1/2 --> P1
Phase classification • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 overexpression
|
lapatinib • letrozole • KW-2450
15d
Clinical
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
Oncotype DX Breast Recurrence Score®Test
|
Verzenio (abemaciclib) • letrozole
15d
New P3 trial • Metastases
|
Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • letrozole • anastrozole • exemestane • camizestrant (AZD9833) • saruparib (AZD5305)
16d
ADJUVANT WIDER: Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (clinicaltrials.gov)
P3, N=3100, Suspended, Novartis Pharmaceuticals | Recruiting --> Suspended
Trial suspension
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative • PGR positive
|
Kisqali (ribociclib) • letrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
16d
Trial completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative
|
tamoxifen • fulvestrant • letrozole • anastrozole • exemestane • amcenestrant (SAR439859)
16d
Superior suppression of serum estrogens during neoadjuvant breast cancer treatment with letrozole compared to exemestane. (PubMed, Breast Cancer Res Treat)
To the best of our knowledge, we present here for the first time a comprehensive and direct head-to-head, intra-patient-cross-over comparison of the aromatase inhibitor letrozole and the aromatase inactivator exemestane concerning their ability to suppress serum estrogen levels in vivo. All in all, our results clearly demonstrate that letrozole therapy results in a more profound suppression of serum E1 and E2 levels compared to exemestane.
Journal
|
ER (Estrogen receptor)
|
ER positive
|
letrozole • exemestane
16d
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer (clinicaltrials.gov)
P2, N=104, Recruiting, Fudan University | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date
|
letrozole • megestrol
17d
Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) (clinicaltrials.gov)
P2, N=90, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: May 2025 --> Apr 2032 | Trial primary completion date: May 2024 --> Apr 2027
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
tamoxifen • fulvestrant • letrozole • anastrozole • exemestane
21d
NCI-2018-01050: Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer (clinicaltrials.gov)
P1/2, N=15, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> Apr 2024 | Trial primary completion date: Dec 2025 --> Apr 2024
Trial completion • Trial completion date • Trial primary completion date • Surgery
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative • ER positive + HER-2 negative
|
Ibrance (palbociclib) • letrozole • hydroxychloroquine
22d
Trial completion • HEOR • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
Herceptin (trastuzumab) • paclitaxel • tamoxifen • Perjeta (pertuzumab) • cyclophosphamide • letrozole • epirubicin • anastrozole • exemestane • goserelin acetate • leuprolide acetate for depot suspension
22d
Enrollment open • Combination therapy • Metastases
|
fulvestrant • letrozole
23d
Enrollment closed
|
ER (Estrogen receptor)
|
Avastin (bevacizumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • paclitaxel • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • Verzenio (abemaciclib) • cyclophosphamide • letrozole • ipatasertib (RG7440) • triptorelin • goserelin acetate • giredestrant (GDC-9545) • inavolisib (GDC-0077)
24d
Preparation of UiO-66 loaded Letrozole nano-drug delivery system: enhanced anticancer and apoptosis activity. (PubMed, AMB Express)
Cell migration results showed that the concentration of 50 µg/ml of UiO-66 bound to letrozole decreased the migration of MCF-7 cells. Generally, the results of this study showed that UiO-66 loaded letrozole can be used as a suitable drug carrier for cellular purposes, as it has increased the effects of cytotoxicity and the rate of apoptosis in breast cancer cell line (MCF-7), so it can be used with more studies used nanocarriers as a drug delivery system.
Journal • IO biomarker
|
BCL2 (B-cell CLL/lymphoma 2) • BAX (BCL2-associated X protein)
|
BCL2 expression • BAX expression
|
letrozole
24d
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab (clinicaltrials.gov)
P2, N=76, Not yet recruiting, Dana-Farber Cancer Institute
New P2 trial • Mismatch repair • Metastases
|
Keytruda (pembrolizumab) • Verzenio (abemaciclib) • letrozole
28d
Real-world experience with CDK4-6 inhibition in the old and oldest old with a diagnosis of breast cancer. (PubMed, Semin Oncol)
Palbociclib+letrozole was the most frequently prescribed treatment (36.8%). Most patients presented hematologic toxicity but to a low degree. The probability of survival increases with treatment.
Journal • Real-world evidence • Real-world
|
HER-2 (Human epidermal growth factor receptor 2)
|
Ibrance (palbociclib) • letrozole
29d
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov)
P2, N=47, Recruiting, City of Hope Medical Center | Active, not recruiting --> Recruiting | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
HER-2 negative
|
Keytruda (pembrolizumab) • Ibrance (palbociclib) • fulvestrant • letrozole
1m
EcZOL: Use of Letrozole for Ectopic Pregnancy (clinicaltrials.gov)
P4, N=130, Recruiting, Hospital de Clinicas de Porto Alegre
New P4 trial
|
letrozole
1m
Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia (clinicaltrials.gov)
P4, N=62, Active, not recruiting, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Combination therapy
|
letrozole • flutamide
1m
Acetate ameliorates ovarian mitochondrial dysfunction in letrozole-induced polycystic ovarian syndrome rat model by improving mitofusin-2. (PubMed, J Physiol Sci)
The present results collectively suggest that acetate ameliorates ovarian mitochondrial abnormality, a beneficial effect that is accompanied by MFn2 with consequent normalization of reproductive-endocrine profile and ovarian function. Perhaps, the present data provide hope for PCOS individuals that suffer infertility.
Preclinical • Journal
|
HIF1A (Hypoxia inducible factor 1, alpha subunit) • HDAC2 (Histone deacetylase 2) • TGFB1 (Transforming Growth Factor Beta 1) • CASP6 (Caspase 6, apoptosis-related cysteine peptidase) • LEP (Leptin) • MFN2 (Mitofusin 2)
|
letrozole
1m
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors (clinicaltrials.gov)
P1/2, N=240, Recruiting, Pfizer | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Sep 2026 --> Dec 2026
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • HR positive + HER-2 positive • PTEN mutation + HR positive
|
fulvestrant • letrozole • atirmociclib (PF-07220060) • tagtociclib (PF-07104091)
1m
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors (clinicaltrials.gov)
P1/2, N=337, Recruiting, Pfizer | Trial completion date: Oct 2027 --> May 2028 | Trial primary completion date: Aug 2026 --> Mar 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • CD4 (CD4 Molecule)
|
HER-2 positive • HR positive • HER-2 negative • CCND1 amplification • CDK4 amplification • HR positive + HER-2 negative • HR positive + HER-2 positive • PTEN mutation + HR positive
|
Xtandi (enzalutamide capsule) • fulvestrant • letrozole • atirmociclib (PF-07220060) • midazolam hydrochloride
1m
Breast Cancer & Antiestrogenic Therapy & Brain (clinicaltrials.gov)
P=N/A, N=180, Not yet recruiting, International Research Training Group 2804
New trial • HEOR
|
tamoxifen • letrozole
1m
New P2 trial
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • letrozole • goserelin acetate • Soltamox (tamoxifen citrate)
1m
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole (clinicaltrials.gov)
P=N/A, N=28, Completed, Pfizer | Active, not recruiting --> Completed | N=42 --> 28 | Trial completion date: Nov 2025 --> Sep 2023 | Trial primary completion date: Nov 2025 --> Sep 2023
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
Ibrance (palbociclib) • letrozole
1m
Enrollment closed
|
CTNNB1 (Catenin (cadherin-associated protein), beta 1)
|
CTNNB1 mutation
|
everolimus • Kisqali (ribociclib) • letrozole
1m
Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. (PubMed, Lancet Oncol)
Gedatolisib plus palbociclib and endocrine therapy showed a promising objective response rate compared with the published results for standard-of-care therapies and had an acceptable safety profile.
P1 data • Journal • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative • PTEN mutation + HR positive
|
Ibrance (palbociclib) • fulvestrant • letrozole • gedatolisib (PF-05212384)
1m
Aromatase Inhibitors and Plasma Lipid Changes in Postmenopausal Women with Breast Cancer: A Systematic Review and Meta-Analysis. (PubMed, J Clin Med)
Studies using anastrozole (ANA), exemestane (EXE), letrozole (LET), and tamoxifen (TMX) were involved. Our results suggest that, despite statistically significant results, EXE and LET may not be sufficient to cause severe dyslipidemia in patients without cardiovascular comorbidities according to the AHA/ACC Guideline on the Management of Blood Cholesterol. However, the results may raise the question of monitoring the effects of AIs in patients, especially those with pre-existing cardiovascular risk factors such as dyslipidemia.
Retrospective data • Review • Journal
|
ER (Estrogen receptor)
|
ER positive
|
tamoxifen • letrozole • anastrozole • exemestane
1m
An Italian Real-World Study Highlights the Importance of Some Clinicopathological Characteristics Useful in Identifying Metastatic Breast Cancer Patients Resistant to CDK4/6 Inhibitors and Hormone Therapy. (PubMed, Biomedicines)
Approximately 177 mBC patients were enrolled, of whom 66 were treated with CD4/6 inhibitors plus letrozole and 111 were treated with CDK4/6 inhibitors and fulvestrant. Furthermore, neutropenia status was associated with a more than doubled risk of progression/death compared to patients without neutropenia (HR = 2.311; p = 0.025). Having identified certain factors that could be associated with the development of neutropenia and considering that neutropenia itself is associated with an increased risk of progression, we believe that the baseline characteristics should be taken into account to reduce cases of neutropenia and disease progression.
Journal • Real-world evidence • Real-world • Metastases
|
CD4 (CD4 Molecule)
|
HR positive
|
fulvestrant • letrozole
1m
Enrollment closed • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
|
HER-2 negative • PIK3CA mutation
|
Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • metformin • inavolisib (GDC-0077)
1m
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer (clinicaltrials.gov)
P2, N=90, Recruiting, Dana-Farber Cancer Institute | Initiation date: Feb 2024 --> Oct 2023
Trial initiation date
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 negative
|
tamoxifen • Verzenio (abemaciclib) • letrozole • anastrozole • exemestane
2ms
Anthracycline-based hepatic arterial infusion chemotherapy achieved 17 months of disease regression in a patient with breast cancer liver metastases resistant to multiple systemic chemotherapies. (PubMed, Int Cancer Conf J)
A 46-year-old woman with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who had multiple LMs and bone metastases underwent seven lines of systemic therapy (paclitaxel/bevacizumab for 38 months; letrozole, nivolumab/fulvestrant, eribulin, gemcitabine/vinorelbine, high-dose toremifene/abemaciclib, and capecitabine for 21 months in total). However, owing to its adverse effects and the continued progression of the LMs, systemic therapy was switched to HAIC (40 mg/body epirubicin on day 1, 4 mg/body mitomycin C on days 1 and 15, and 500 mg/body 5-fluorouracil on days 1, 8, and 15; 28-day courses)...Our findings identify a potential window for the use of traditional chemotherapeutic agents such as anthracyclines. Novel strategies to improve drug delivery are warranted in the future.
Journal
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
|
ER positive • HER-2 negative • EGFR positive
|
Opdivo (nivolumab) • Avastin (bevacizumab) • gemcitabine • paclitaxel • 5-fluorouracil • capecitabine • Verzenio (abemaciclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • epirubicin • vinorelbine tartrate • mitomycin
2ms
A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread (clinicaltrials.gov)
P1, N=198, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1
Phase classification • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CDK4 (Cyclin-dependent kinase 4) • CDK6 (Cyclin-dependent kinase 6)
|
HR positive • HER-2 negative • EGFR positive
|
Herceptin (trastuzumab) • everolimus • tamoxifen • Perjeta (pertuzumab) • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • samotolisib (LY3023414)
2ms
Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1) (clinicaltrials.gov)
P1, N=120, Active, not recruiting, Rovi Pharmaceuticals Laboratories | Trial completion date: Feb 2024 --> May 2024 | Trial primary completion date: Feb 2024 --> May 2024
Trial completion date • Trial primary completion date
|
letrozole
2ms
Ribociclib plus Endocrine Therapy in Early Breast Cancer. (PubMed, N Engl J Med)
Ribociclib plus an NSAI significantly improved invasive disease-free survival among patients with HR-positive, HER2-negative stage II or III early breast cancer. (Funded by Novartis; NATALEE ClinicalTrials.gov number, NCT03701334.).
Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive • PTEN mutation + HR positive
|
Kisqali (ribociclib) • letrozole • anastrozole • goserelin acetate
2ms
A rare case of Takotsubo cardiomyopathy. (PubMed, Eur Rev Med Pharmacol Sci)
Pharmacovigilance and experimental studies are warranted to confirm any causative relationship and to explore the underlying pathophysiology, respectively.
Clinical • Journal
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative • EGFR positive • HR positive + HER-2 negative
|
Ibrance (palbociclib) • letrozole