- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Metastases: ABIGAIL: ABemaciclib, ET (clinicaltrials.gov) - Apr 22, 2021 P2, N=160, Not yet recruiting, Initiation date: Feb 2021 --> Jul 2021 Trial completion date: Feb 2024 --> May 2024
- |||||||||| limantrafin (CB-103) / Cellestia Biotech
Enrollment open, Trial initiation date: CAILA: CB-103 Plus NSAI In Luminal Advanced Breast Cancer (clinicaltrials.gov) - Apr 20, 2021 P2, N=80, Recruiting, Palbociclib with letrozole may be a good treatment in the preoperative stage for luminal breast cancer that is resistant to chemotherapy. Not yet recruiting --> Recruiting | Initiation date: Jan 2021 --> Apr 2021
- |||||||||| tamoxifen / Generic mfg., fulvestrant / Generic mfg.
Clinical, Review, Journal, BRCA Biomarker: Clinical Challenges in the Management of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: A Literature Review. (Pubmed Central) - Apr 15, 2021 However, the optimal sequencing of treatments is unknown, especially following disease progression on a CDK4/6 inhibitor. This review aims to provide practical guidance for the management of HR+, HER2- MBC based on available data and the utility of genomic biomarkers, including germline breast cancer genes 1 and 2 (BRCA1/2) mutations, and somatic estrogen receptor alpha gene (ESR1), HER2, and PIK3CA mutations.
- |||||||||| letrozole / Generic mfg., methotrexate / Generic mfg.
Journal: Letrozole: future alternative to methotrexate for treatment of ectopic pregnancy? (Pubmed Central) - Apr 13, 2021 This review aims to provide practical guidance for the management of HR+, HER2- MBC based on available data and the utility of genomic biomarkers, including germline breast cancer genes 1 and 2 (BRCA1/2) mutations, and somatic estrogen receptor alpha gene (ESR1), HER2, and PIK3CA mutations. No abstract available
- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg., exemestane / Generic mfg.
[VIRTUAL] Aromatase Inhibitor-induced Dermatologic Adverse Effects: A Systematic Review () - Apr 10, 2021 - Abstract #AADVMX2021AAD_VMX_266; The most commonly used AI was anastrozole (39%) followed by letrozole (36%) and exemestane (17%). While dermatology-related AEs are rare after AI use, our study shows that there may be a considerable proportion of patients experiencing dermatology-related AEs.
- |||||||||| letrozole / Generic mfg.
Journal: Identification of new probe substrates for human CYP20A1. (Pubmed Central) - Apr 10, 2021 Using one of these probes, we demonstrate inhibition of CYP20A1 activity by 1-benzylimidazole, ketoconazole and letrozole. Finally, we show that the combination of two common single nucleotide polymorphisms (SNPs) of CYP20A1 leads to an enzyme (CYP20A1Leu97Phe346) with reduced activity.
- |||||||||| letrozole / Generic mfg.
Preclinical, Journal: Therapeutic potential of quercetin in an animal model of PCOS: Possible involvement of AMPK/SIRT-1 axis. (Pubmed Central) - Apr 7, 2021 Therefore, this study aimed to investigate the mechanisms underlying quercetin's positive effects by modulating key components of energy homeostasis and adipose tissue hormones in rats with letrozole-induced PCOS...Quercetin also reversed the PCOS-induced alteration in adipose tissue levels of adiponectin, visfatin, and resistin. Modulation of energy homeostasis through key components involved in this axis, as well as regulation of hormones releasing from adipose tissue may be the main underlying mechanisms for positive effects of quercetin in PCOS.
- |||||||||| fulvestrant / Generic mfg.
Clinical, Journal: First clinical experience with CDK4/6 inhibitors in breast cancer therapy. (Pubmed Central) - Apr 7, 2021 The CDK4/6 inhibitors have an important and promising role in the therapy of breast cancer patients. Patient age and therapy duration do not influence the use of palbociclib or ribociclib, although it may be important which AI is used in combination with palbociclib.
- |||||||||| Kisqali (ribociclib) / Novartis
Enrollment closed, Trial primary completion date, Combination therapy, Metastases: AMALEE: Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) - Apr 2, 2021 P2, N=376, Active, not recruiting, Treatment with adjuvant letrozole showed very favorable treatment outcomes and good tolerability among Korean postmenopausal women with ER-positive breast cancer, independent of ER expression. Recruiting --> Active, not recruiting | Trial primary completion date: Feb 2026 --> Jun 2021
- |||||||||| letrozole / Generic mfg.
Journal: Effect of Letrozole on sperm parameters, chromatin status and ROS level in idiopathic Oligo/Astheno/Teratozoospermia. (Pubmed Central) - Mar 19, 2021 Our case report highlights the key role of the nephrologist in treating a complex and fragile oncologic patient, achieving the full correction of several severe renal disorders, hemodialysis avoidance and survival improvement. Letrozole treatment can effectively increase spontaneous pregnancies by improving sperm parameters and sperm chromatin integrity in men with iOAT and T:E2 ratio ≤ 10.
- |||||||||| letrozole / Generic mfg., sorafenib / Generic mfg.
Trial termination, Metastases: Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer (clinicaltrials.gov) - Mar 15, 2021 P1/2, N=54, Terminated, For the first time, we characterized the global proteomic signature of CSC-enriched letrozole-resistant cells associated with protein synthesis, which may implicate a role for midasin in endocrine resistance. Active, not recruiting --> Terminated
- |||||||||| Ibrance (palbociclib) / Pfizer
[VIRTUAL] Palbociclib (Cyclin-Dependent Kinases CDK4 and CDK6 Selective Inhibitor) Induced Grade 3 Interstitial Pneumonitis () - Mar 14, 2021 - Abstract #ATS2021ATS_4366; Introduction: In postmenopausal women, Palbociclib is a selective cyclin-dependent kinase CDK4 and CKD6 inhibitor to treat hormone receptor-positive metastatic breast cancer in combination with Letrozole (Aromatase Inhibitor)...She received adjuvant chemotherapy, followed by Anastrozole, for five years...She was managed conservatively with discontinuation of Palbociclib, and IV steroids were initiated (20 mg dexamethasone daily)...On the day of discharge, she was discharged on PO Prednisone dose 0.5mg/kg for six weeks along with oral Bactrim full dose three times a week for PJP prophylaxis...Rarely Palbociclib is associated with interstitial pneumonitis (incidence <1%) due to unknown mechanisms. The early identification of this side effect and treatment with immediate cessation of the drug and corticosteroids could be a life-saving measure, as is the case with our patient.
- |||||||||| Ibrance (palbociclib) / Pfizer
[VIRTUAL] A new ER+Her2- Palbociclib resistant breast cancer PDX model () - Mar 13, 2021 - Abstract #AACR2021AACR_3942; During treatment, the patient developed the liver metastasis, whereas the WHIM84 model was grafted from a second patient with a bone metastasis prior to the patient seeing Palbociclib, but once she did, the tumor was unresponsive.In this PDX study, athymic nude mice bearing either WHIM81 or WHIM84 tumors were treated with 3 different concentrations of Palbociclib (10 mg/kg, 25 mg/kg and 75 mg/kg) administered daily for the duration of the experiment and also included an arm with Fulvestrant administered once weekly through a subcutaneous injection of 3 mg/dose...Nature Reviews Drug Discovery. 19, 10.
- |||||||||| Herceptin (trastuzumab) / Roche, Tecentriq (atezolizumab) / Roche, Reolysin (pelareorep) / Oncolytics, Andrus Reo
[VIRTUAL] A window-of-opportunity study with atezolizumab and the oncolytic virus pelareorep in early breast cancer (AWARE-1) () - Mar 11, 2021 - Abstract #AACR2021AACR_876; P1 Detailed TCR-seq, Ventana PD-L1 assay results, and IHC analysis will be presented, focusing on differences between patients receiving pela in the absence or presence of atezolizumab (Cohorts 1 and 2, respectively), and between CelTIL scores of responders and non-responders. Overall, these data demonstrate that pela can promote an inflamed tumor phenotype that allows for synergy with checkpoint blockade therapy in breast cancer.
- |||||||||| Piqray (alpelisib) / Novartis
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - Mar 10, 2021 P1, N=52, Active, not recruiting, Among the top 5 features from the model, patients with a larger relative abundance of Gemmiger formicillis have increased probability of responding to therapy (p<0.05 uncorrected), whereas an increase of Bacteroides vulgatus have reduced probability of responding to therapy (p<0.05 uncorrected). Completed --> Active, not recruiting | Trial completion date: Apr 2020 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Apr 2022
- |||||||||| letrozole / Generic mfg., everolimus / Generic mfg.
Trial completion, Combination therapy, Metastases: Bolero-4: Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer (clinicaltrials.gov) - Mar 10, 2021 P2, N=203, Completed, Completed --> Active, not recruiting | Trial completion date: Apr 2020 --> Apr 2022 | Trial primary completion date: Apr 2020 --> Apr 2022 Active, not recruiting --> Completed
- |||||||||| letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Evaluation of IM Letrozole ISM (clinicaltrials.gov) - Mar 10, 2021 P1, N=120, Active, not recruiting, Active, not recruiting --> Completed Trial completion date: Jan 2021 --> Oct 2021 | Trial primary completion date: Jan 2021 --> Oct 2021
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