- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg.
Trial completion date, Trial primary completion date: Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer (clinicaltrials.gov) - Jun 1, 2022 P2, N=29, Recruiting, Trial completion date: Jul 2022 --> Jul 2024 | Trial primary completion date: Jul 2022 --> Jul 2023 Trial completion date: Jun 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2023
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Journal: Development and Validation of a Novel LC-MS/MS Method for the Simultaneous Determination of Abemaciclib, Palbociclib, Ribociclib, Anastrozole, Letrozole, and Fulvestrant in Plasma Samples: A Prerequisite for Personalized Breast Cancer Treatment. (Pubmed Central) - May 30, 2022 The inter-day precision ranged from 1.6% to 14.9%, with accuracy between -14.3% and 14.6%, which is in accordance with the EMA and ICH guidelines on bioanalytical method validation. The method was successfully applied to samples from patients treated for HR+, HER2- breast cancer.
- |||||||||| Clinical, Review, Journal: Clinical Review on the Management of Hormone Receptor-Positive Metastatic Breast Cancer. (Pubmed Central) - May 19, 2022
In the past decade, the introduction of molecularly targeted agents against intracellular targets such as mammalian target of rapamycin (everolimus), cyclin-dependent kinases 4 and 6 (palbociclib, ribociclib, and abemaciclib), and phosphatidylinositol 3-kinase (alpelisib) has offered patients effective nonchemotherapy-based options, which are improving outcomes...Still, formatting a plan for these patients includes taking into account traditional prognostic factors such as menopausal status, previous treatments, disease-free interval for those patients with early breast cancer that has recurred, and tumor burden. To assist in developing this treatment plan, we will review the current data with systemic agents in the management of these patients.
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Journal: A Case of Postoperative Pulmonary Metastasis of Breast Cancer with Complete Response by Abemaciclib plus Fulvestrant Therapy (Pubmed Central) - May 18, 2022 She received postoperative adjuvant therapy with oral anastrozole(ANA)for 5 years...However, the first CDK4/6 inhibitor, palbociclib, caused severe myelosuppression even when the dose was reduced by 2 levels...In June 2019, new multiple lung metastases appeared, and the patient was switched from ANA to fulvestrant, after which complete response was achieved in 6 months. CT in June 2021 showed no recurrence, and the patient(now 80-year-old)continues to take abemaciclib plus fulvestrant therapy.
- |||||||||| Verzenio (abemaciclib) / Eli Lilly
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Abemaciclib in Indian Women With Advanced Breast Cancer (clinicaltrials.gov) - May 11, 2022 P4, N=200, Recruiting, Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Dec 2022 --> Dec 2024 Trial completion date: Aug 2022 --> Mar 2023 | Trial primary completion date: Aug 2022 --> Mar 2023
- |||||||||| Trial completion date, Combination therapy, Metastases: BOLERO-5: A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor (clinicaltrials.gov) - May 3, 2022
P2, N=159, Active, not recruiting, Trial completion date: Nov 2025 --> Sep 2023 Trial completion date: Apr 2022 --> Nov 2022
- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg., tamoxifen / Generic mfg.
Short-term preoperative endocrine therapy allows to estimate and revert patient prognosis with further treatment plan correction in HR+ HER2- early breast cancer patients. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_5949; HR+ HER2- BC pts stages I-II any level of Ki67 independent from grade have received P-ET (letrozole (L)/anastrozole (A)/tamoxifen (TAM)) no less than 2 weeks until surgery in MCSC named after A.S. Loginov. In HR+ HER2- early BC pts short-term P-ET simply allows to estimate pts prognosis and further AT strategy proper planning: to identify the pts population of whom CT can be avoided while maintaining treatment efficacy with a better quality of life (42% pts of IIT) (1), to radically change the planned AT to achieve optimal treatment results (2,4% pts of IIT) (2).
- |||||||||| Eligard (leuprolide acetate) / Tolmar, Sanofi, Recordati
A phase 3, single arm, open-label study evaluating ovarian suppression following 3-month leuprolide acetate for injectable suspension in combination with endocrine therapy in premenopausal subjects with HR+, HER2-negative breast cancer (OVELIA). (Available On Demand; 378b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3305; P3 Achievement of ovarian suppression will be defined as ≥ 90% of subjects with luteinizing hormone (LH) levels < 4 IU/L at Week 6. Secondary endpoints include suppression of LH, E2 (< 20 pg/mL for tamoxifen cohort and < 2.72 pg/mL for AI cohort) and absence of menses at weeks 6, 12, 24, 36, and 48.
- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg., exemestane / Generic mfg.
Aromatase inhibitors for breast cancer therapy: Analysis of real-world FAERS data. (Available On Demand; 429) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1138; Together with the promising anti-tumor activity observed with the combination therapy in HR+/HER2- ABC, further trials are warranted. The findings in this study highlight trends for selected AEs with various AI regimens, provide further insights, and help guide therapeutic decisions for patients with HRPBC.
- |||||||||| Management of the Side Effect of Hormone Therapy () (RM 3(Walker Hall 1)) - Apr 22, 2022 - Abstract #GBCC2022GBCC_186;
This is crucial to increase treatment adherence and quality of life during adjuvant endocrine therapy. An individualized approach when choosing an intervention to control these symptoms is likely to have better chances of achieving a positive effect on oncological outcomes and quality of life.
- |||||||||| Must-have Knowledge about GnRH Agonist for Patients with Breast Cancer (RM 5(Art Hall)) - Apr 22, 2022 - Abstract #GBCC2022GBCC_164;
In the light of increased morbidity with aromatase inhibitors and in the context of the reported data of the SOFT/TEXT trials, most patients are optimally treated with tamoxifen and ovarian function suppression (OFS). However, the option of aromatase inhibitors and OFS should be discussed on an individual basis.
- |||||||||| letrozole / Generic mfg., anastrozole / Generic mfg., exemestane / Generic mfg.
Clinical, Journal: Simultaneous Quantification of Aromatase Inhibitors and Estrogens in Postmenopausal Breast Cancer Patients. (Pubmed Central) - Apr 21, 2022 We present here an assay suitable for the simultaneous measurement of serum levels of all third-generation AIs and ultra-low levels of estrogens, providing a powerful new tool to study drug efficacy and compliance. The method is highly valuable for postmenopausal patients whose pretreatment estradiol levels are below the threshold of detection for most routine assays, but still require suppression.
- |||||||||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis
Clinical, Retrospective data, Journal: Evaluation of Information Theoretic Network Meta-analysis to Rank First-Line Anticancer Regimens for Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer. (Pubmed Central) - Apr 20, 2022 Older monotherapies that continue to be used in RCTs in comparator groups, such as anastrozole (251 of 252) and letrozole (252), fell to the bottom of the rankings...In this network meta-analysis study, combination therapies appeared to be associated with better outcomes than monotherapies in the treatment of HR-positive, ERBB2-negative MBC. These findings suggest that IT-NMA is a promising method for longitudinal ranking of anticancer regimens from RCTs with different end points, sparse interconnectivity, and decades-long timeframes.
- |||||||||| rodatristat ethyl (RVT-1201) / Sumitomo Dainippon, sotatercept (ACE-011) / BMS, Merck (MSD)
Review, Journal: "NOVEL MECHANISMS TARGETED BY DRUG TRIALS IN PULMONARY ARTERIAL HYPERTENSION". (Pubmed Central) - Apr 13, 2022 In this review, we will discuss the preclinical studies that led to prioritization of these mechanisms and will discuss recently completed and ongoing phase 2/3 trials using novel interventions such as sotatercept, anastrozole, rodatristat ethyl, tyrosine kinase inhibitors, and endothelial progenitor cells among others. We anticipate that the next generation of compounds will build upon the success of the current standard of care and improve clinical outcomes and quality of life of patients afflicted with PAH.
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