- |||||||||| Piqray (alpelisib) / Novartis
THE ALPELISIB (ALP) EXPERIENCE IN THE SOLAR-1 AND BYLIEVE STUDIES: PERSPECTIVES FOR PRACTITIONERS CARING FOR PATIENTS (PTS) WITH HORMONE RECEPTOR-POSITIVE (HR+), HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE (HER2–) ADVANCED BREAST CANCER (ABC) ([VIRTUAL]) - Dec 2, 2021 - Abstract #ABC62021ABC6_4; P2, P3 Pts with HR+, HER2– ABC are often treated with endocrine therapy (ET; fulvestrant [FUL], or aromatase inhibitor [AI]) ± cyclin-dependent kinase 4/6 inhibitor (CDK4/6i)...In Cohorts A and B (primary endpoint reported), adding ALP to FUL or letrozole, respectively, was effective in pts treated with CDK4/6is + AI or FUL as immediate prior tx; 50.4% and 46.1% of pts were alive and without progression at 6 mo...AEs were manageable with close monitoring and early intervention. Thus, ALP should be considered for tx of pts with HR+, HER2–, PIK3CA-mut ABC.
- |||||||||| Reolysin (pelareorep) / Oncolytics, Andrus Reo
Trial completion date, Trial primary completion date: AWARE-1: A Window-of-opportunity Study of Pelareorep in Early Breast Cancer (clinicaltrials.gov) - Dec 1, 2021 P1, N=29, Recruiting, Trial completion date: Nov 2021 --> Nov 2022 | Trial primary completion date: Nov 2021 --> Nov 2022 Trial completion date: Dec 2020 --> May 2022 | Trial primary completion date: Oct 2020 --> Feb 2022
- |||||||||| Ibrance (palbociclib) / Pfizer
Journal, HEOR: Handling Uncertainty in Cost-Effectiveness Analysis: Budget Impact and Risk Aversion. (Pubmed Central) - Nov 29, 2021 Moreover, we show that the cost-effectiveness risk-aversion curve (CERAC) allows the analyst to incorporate different levels of risk-aversion into the analysis and can, therefore, be used to inform decision-makers who are risk-averse. We use data from a published cost-effectiveness model of palbociclib in addition to letrozole versus letrozole alone for the treatment of oestrogen-receptor positive, HER-2 negative, advanced breast cancer to demonstrate the differences between CEAC, CEAFC and CERAC, and show how these can jointly be used to inform decision and policy makers.
- |||||||||| letrozole / Generic mfg.
UPDATE ON FERTILITY PRESERVATION () - Nov 27, 2021 - Abstract #EHOC2021EHOC_395; For estrogen sensitive tumors including breast and endometrial cancers, safer ovarian stimulation protocols incorporating letrozole were defined with high success rates...However, with increased clinical success together with increasing number of healthy live births in recent years, ovarian tissue freezing is now considered as an "acceptable" method for fertility preservation. The feasibility of autologous hematopoietic stem cell transplantation to improve pregnancy rates in patients with poor ovarian reserve has also been investigated with reported success rates in limited number of recent studies.
- |||||||||| Herceptin (trastuzumab) / Roche, trastuzumab/pertuzumab (EG13084) / EirGenix, Perjeta (pertuzumab) / Roche
New trial: Neoadjuvant Treatment of Breast Cancer (clinicaltrials.gov) - Nov 22, 2021 P=N/A, N=300, Not yet recruiting,
- |||||||||| Review, Journal: The role of ERα36 in cell type-specific functions of estrogen and cancer development. (Pubmed Central) - Nov 21, 2021
These factors influence the ERK kinetic and determine the ultimate mitogenic or antimitogenic signaling of estrogen, leading to cell survival or cell death. In this review, we summarize the recent organ-specific, cellular and molecular events and the mechanisms involved in estrogen effects mediated through the ERα36/ ERα66 with a particular focus on carcinomas where more clinical information has recently emerged.
- |||||||||| letrozole / Generic mfg.
Trial completion date, Trial primary completion date: Evaluation of IM Letrozole ISM (clinicaltrials.gov) - Nov 18, 2021 P1, N=120, Active, not recruiting, Also taking into account treatment tolerability, maintenance endocrine therapy remains the standard. Trial completion date: Oct 2021 --> Jan 2022 | Trial primary completion date: Oct 2021 --> Jan 2022
- |||||||||| letrozole / Generic mfg., everolimus / Generic mfg., exemestane / Generic mfg.
Preclinical, Journal: Chemical inhibitor anticancer drugs regulate mechanical properties and cytoskeletal structure of non-invasive and invasive breast cancer cell lines: Study of effects of Letrozole, Exemestane, and Everolimus. (Pubmed Central) - Nov 16, 2021 While metabolic activity of cell lines was highly affected by drug treatment, significant alterations in Young's modulus of cell bodies, nuclear areas, and actin content and distribution were reported with higher impact on invasive cells. It was concluded that regulation of mechanical behavior of cells by all three drugs emphasizes the cross talk between chemical and physical signaling cascades, and describes a correlation between biological and physical behaviors of cancer cells which might give an insight to a better understanding of mechanisms by which anti-cancer drugs function to enhance their performances.
- |||||||||| letrozole / Generic mfg.
Trial completion, Trial completion date, Trial primary completion date: Protocols of IVF/ICSI in Poor Responders (clinicaltrials.gov) - Nov 16, 2021 P3, N=132, Completed, It was concluded that regulation of mechanical behavior of cells by all three drugs emphasizes the cross talk between chemical and physical signaling cascades, and describes a correlation between biological and physical behaviors of cancer cells which might give an insight to a better understanding of mechanisms by which anti-cancer drugs function to enhance their performances. Recruiting --> Completed | Trial completion date: Mar 2022 --> Oct 2021 | Trial primary completion date: Jun 2021 --> Sep 2021
- |||||||||| leuprorelin depot / Generic mfg., dydrogesterone / Generic mfg.
Retrospective data, Journal: Dydrogesterone in the treatment of endometriosis: evidence mapping and meta-analysis. (Pubmed Central) - Nov 12, 2021 Limited evidence suggests that dydrogesterone may have some advantages over gestrinone, GnRH agonists, and other therapeutic interventions in treating endometriosis. However, this conclusion should be interpreted with caution.
- |||||||||| letrozole / Generic mfg.
Preclinical, Journal: Ameliorative effects of fisetin in letrozole-induced rat model of polycystic ovary syndrome. (Pubmed Central) - Nov 12, 2021 However, this conclusion should be interpreted with caution. Our results showed that, fisetin treatment caused significant alleviating effects by restoring PCOS-induced alterations in the key genes involved in energy homeostasis and antioxidant enzymes, suggesting that it may have a key role in combating with PCOS.
- |||||||||| Tecentriq (atezolizumab) / Roche
Trial completion date, Trial primary completion date, IO biomarker, MSi-H Companion diagnostic, PARP Companion diagnostic, PD(L)-1 companion diagnostic: AFT-50 EndoMAP: A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer (clinicaltrials.gov) - Nov 11, 2021 P1/2, N=60, Recruiting, Our results showed that, fisetin treatment caused significant alleviating effects by restoring PCOS-induced alterations in the key genes involved in energy homeostasis and antioxidant enzymes, suggesting that it may have a key role in combating with PCOS. Trial completion date: Sep 2025 --> Oct 2026 | Trial primary completion date: Sep 2024 --> Oct 2025
- |||||||||| tamoxifen / Generic mfg.
Clinical, Clinical data, Review, Journal: Impact of obesity on clinical outcomes in hormone receptor-positive breast cancer: a systematic review. (Pubmed Central) - Nov 7, 2021 The results of our systematic review highlight a need for further research exploring the optimal endocrine therapies for obese women. There is insufficient evidence at present to recommend tailoring adjuvant endocrine therapy with use of specific AIs or for dosing modifications of AIs in this patient population.
- |||||||||| minocycline / Generic mfg.
Preclinical, Journal: Beneficial effects of minocycline on the ovary of polycystic ovary syndrome mouse model: Molecular docking analysis and evaluation of TNF-α, TNFR2, TLR-4 gene expression. (Pubmed Central) - Nov 7, 2021 After 28 days, the mice were divided into five groups, including control, PCOS, minocycline control, minocycline PCOS model (50 mg/kg), and letrozole PCOS (0.5 mg/kg)...Minocycline treatment in PCOS led to a significant decrease in E2 (P < 0.01) and graafian follicles (P < 0.001) and a significant increase in the CL numbers (P < 0.05). Our findings showed the positive effects of minocycline on estradiol level, CL and graafian follicles counts, suggesting that minocycline might inhibit these proteins and improve ovulation in our mouse model of PCOS.
- |||||||||| letrozole / Generic mfg.
PK/PD data, Journal: The pharmacokinetics of letrozole and its effect on gonadotropins in anestrous ewes. (Pubmed Central) - Nov 6, 2021 This increase in FSH concentration may create a potential for the use of letrozole in ovarian superstimulation protocols. Favorable pharmacokinetic properties (long t and good bioavailability) of letrozole for IM and SC routes require further investigation before use in estrus induction or estrus synchronization protocols in sheep.
- |||||||||| letrozole / Generic mfg., exemestane / Generic mfg.
Clinical, Journal: Lack of cross-resistance between non-steroidal and steroidal aromatase inhibitors in breast cancer patients: the potential role of the adipokine leptin. (Pubmed Central) - Nov 4, 2021 Our findings suggest an additional and direct effect of exemestane on CYP-19 (aromatase) synthesis presumably due to effects on the CYP19 promoter use that is not present during therapy with the non-steroidal aromatase inhibitor letrozole. Our findings provide new insights into the influence of clinically important aromatase inhibitors on cytokine levels in vivo that contribute to the understanding of the clinically observed lack of cross-resistance between non-steroidal and steroidal aromatase inhibitors in breast cancer patients.
- |||||||||| letrozole / Generic mfg.
Review, Journal: Fertility Issues in Polycystic Ovarian Disease: A Systematic Approach. (Pubmed Central) - Oct 27, 2021 Ovulation induction is considered first-line management of infertility in women with PCOS, with letrozole superior to clomiphene. Women with PCOS undergoing in vitro fertilization are high risk for ovarian hyperstimulation syndrome but also have a higher live birth rate compared with controls.
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