exemestane / Generic mfg. - LARVOL DELTA

Drug utilisation evaluation of oral anticancer therapy in a south indian cancer centre (ESMO Asia 2025) - "Among targeted therapies, Gefitinib, Osimertinib, Crizotinib, Afatinib, Lorlatinib, and Nilotinib demonstrated consumption of 30 DDDs per patient over 30 days. Lower consumptions were observed with Lenvatinib and Cabozantinib with 13.3 DDDs and 11.25 DDDs per patient respectively. In the hormonal therapy group, Letrozole, Tamoxifen, Bicalutamide, Anastrozole, Enzalutamide, and Exemestane were all prescribed in line with WHO standards (30 DDDs per patient), whereas Abiraterone exhibited lower consumption of 15 DDDs per patient. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Prescribing patterns and consumption metrics were largely consistent with WHO criteria, indicating rational oral anticancer drug use. Dose deviations occurred, though reasons were unclear and may relate to adverse effects, indication-specific or patient factors, or economic constraints. Further research is warranted..."

Oncology • Oral Cancer

Developing Gaussian process regression, Lasso regression, and Nu-support vector regression models for predicting solubility of exemestane in supercritical CO2. (PubMed, Sci Rep) - "This work contributes to the growing application of machine learning techniques in pharmaceutical process modeling, particularly in supercritical fluid-based drug delivery systems. The proposed GPR model provides a reliable and efficient tool for predicting solubility, supporting the design and optimization of scCO2-assisted drug formulation methods."

Journal • Oncology

Lack of effects of S-equol-containing supplement on the pharmacokinetics of oral hormone therapy drugs for breast cancer. (PubMed, Cancer Chemother Pharmacol) - "S-equol-containing supplement has no clinically significant effects on the exposure of oral hormone therapy drugs for breast cancer. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: jRCTs031200084, August 13th, 2020."

Journal • PK/PD data • Breast Cancer • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Aromatase inhibitors and medication-related osteonecrosis of the jaw: friends, foes, or bystanders? (PubMed, Crit Rev Oncol Hematol) - "Letrozole was the most frequently prescribed AI, followed by anastrozole and exemestane. MRONJ was reported in 43 studies, with 1,147 cases among 45,121 AI users (2.5% of AI users in the included samples), the majority of whom were concomitantly treated with zoledronic acid and/or denosumab...Data demonstrate the difficulty of disentangling the effects of AI from those of antiresorptive therapy in MRONJ pathogenesis. Future research should consider AI as potential confounders in analytical studies to clarify their independent contribution, if any, to observed MRONJ occurrences."

Journal • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Comparing Cross-Toxicities and Efficacy of Everolimus and Alpelisib in Different Sequences in Metastatic Breast Cancer Patients (SABCS 2025) - "Fulvestrant was the most common endocrine therapy with AL (90% in EV-AL, 94% in AL-EV) vs exemestane with EV (67% in EV-AL, 75% in AL-EV). This study has assessed CrIn of SEs across EV and AL use. Notably, all patients who developed hypG and half who developed rash on EV also developed them again on AL. These CrIn results could help clinicians use preemptive strategies (like metformin, topical steroids) while using 2nd PAMi."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

A Phase 2 Trial of (Z)-endoxifen + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+, HER2-, Breast Cancer (EVANGELINE) (SABCS 2025) - P2 | "Problematically, only 41% of patients reach this threshold with tamoxifen compared to 78% with AI+OFS (Nitz JCO 2022)...Eligible patients are premenopausal women with Stage IIA/IIB ER+/HER2- breast cancer.• Part 1 (PK Run-in): assessed 40mg vs 80mg ENDX (+/- OFS) in 22 patients.• Part 2: patients with baseline Ki-67 >10% were randomized to 40 mg ENDX + goserelin or exemestane + goserelin for 6 months with the primary objective being 4-week ESD rate...EVANGELINE is the first trial to evaluate (Z)-endoxifen + OFS as neoadjuvant therapy in premenopausal ER+/HER2- breast cancer. By targeting both ER and PKC pathways, ENDX may offer a well-tolerated alternative to AI-based regimens and expand endocrine therapy options for this population. Clinical Trial Registration: NCT05607004"

Clinical • P2 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PRKCB

Randomized phase 3 trial evaluating KAT6 inhibitor PF-07248144 plus fulvestrant in HR+HER2− advanced/metastatic breast cancer after progression on CDK4/6 inhibitor-based therapy (SABCS 2025) - " This open-label, randomized phase 3 trial is comparing PF-07248144 plus FUL versus everolimus (EVE) plus ET [FUL or exemestane (EXE)]) in patients with HR+HER2− ABC. The primary endpoint is progression-free survival by blinded independent central review. Overall survival is a key secondary endpoint; other secondary endpoints include objective response, duration of response, clinical benefit rate, safety, and pharmacokinetics of PF-07248144."

Clinical • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • KAT6A • KAT6B • PIK3CA • PTEN

Ribociclib with fulvestrant versus physician's choice treatments in patients who recurred after completion of adjuvant cyclin-dependent kinase 4/6 inhibitors as first-line treatment in HR+, HER2- advanced breast cancer (SABCS 2025) - P2 | "Patients will be randomized in a 1:1 ratio to either the treatment arm (ribociclib and fulvestrant) or the control arm (PCT: fulvestrant or exemestane plus everolimus)...The patients must have had previously received at least 1 year of adjuvant abemaciclib or ribociclib and a minimum of 2 years of adjuvant endocrine therapy (either alone or in combination with CDK4/6 inhibitors)...The planned overall study duration is 72 months (36 months for accrual and randomization, 36 months of follow-up for primary endpoint PFS). This trial received local Institutional Review Board approval and is registered in ClinicalTrials.gov (NCT06849947)."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Carcinoma en Cuirasse (SABCS 2025) - "She was treated with adjuvant dose-dense doxorubicin and cyclophosphamide, followed by paclitaxel (ddAC-T). She then received adjuvant radiation therapy which was followed by anastrozole...She later switched from palbociclib to abemaciclib because of insurance issues, and continued exemestane and abemaciclib until progression of disease locally. Due to aversion to parenteral treatment, she was started on everolimus with exemestane instead. Unfortunately, she had further progression of disease locally at which time she agreed to treatment with fulvestrant and everolimus but had worsening of her carcinoma en cuirasse (Figure 1b). It is likely that she had poor disease control because of intermittent compliance with all of her treatment. She most recently received repeat palliative radiation followed by capecitabine with improvement of her skin lesions (Figure 1c)."

Breast Cancer • Oncology • HER-2

Clinical and biomarker subgroup analysis of evERA Breast Cancer: A Phase III trial of giredestrant plus everolimus in patients with estrogen receptor-positive, HER2-negative advanced breast cancer previously treated with a CDK4/6 inhibitor (SABCS 2025) - P3 | "Methods Pts who had ER+, HER2- aBC with disease progression (PD) post-CDK4/6i + ET in the aBC setting, or relapse during/after CDK4/6i + ET in the adjuvant setting, were randomized 1:1 to once-daily oral 30 mg GIRE + 10 mg E or SOC ET (exemestane, fulvestrant, or tamoxifen) + E until PD or unacceptable toxicity. Conclusions GIRE + E led to clinically meaningful improvements in INV-PFS vs SOC ET + E irrespective of PIK3CAm and PIK3CA/AKT1/PTEN alt, and other key relevant subgroups, regardless of ESR1m status. These data support the use of GIRE + E vs SOC ET + E in pts with ER+, HER2- aBC post-CDK4/6i + ET."

Biomarker • Clinical • Metastases • P3 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PIK3CA • PTEN

Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Updated efficacy results from the phase 3 EMBER-3 trial (SABCS 2025) - "Background: At the primary progression-free survival (PFS) analysis, the phase 3 EMBER-3 trial in patients (pts) with ER+, HER2- ABC demonstrated significant PFS benefit with imlunestrant (imlu) vs standard therapy (SOC: fulvestrant or exemestane) in pts with ESR1 mutations (ESR1m), and with imlunestrant+abemaciclib (imlu+abema) vs imlu in all pts, regardless of ESR1m status. At a median follow-up of 28.5 months, a clinically meaningful improvement in OS was observed with imlu vs SOC in pts with ESR1m (corresponding to a numeric increase in mOS of 11.4 months), however, the boundary for significance was not achieved. Also, a favorable OS trend emerged with imlu+abema vs imlu in all pts, regardless of ESR1m. Sustained benefit in PFS, with clinically meaningful improvement in TTC, and PFS2 further highlight the efficacy of imlu-based regimens."

Clinical • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • ER • HER-2

A Multicenter, Open-Label, Phase 2 Study of nab-Sirolimus (HB1901) Plus Endocrine Therapy in HR+/HER2- Advanced Breast Cancer Following Standard Therapy Failure (SABCS 2025) - P2 | "34 and 31 eligible patients were allocated to receive nab-Sirolimus 100 mg/m2 Q2W + fulvestrant or exemestane, respectively. Nab-sirolimus exhibited manageable toxicity and promising antitumor activity, particularly when combined with fulvestrant (achieving an ORR of 29% and a median PFS of 7.5 months). Nab-sirolimus + fulvestrant showed good efficacy in both PIK3CA/AKT1/PTEN altered and wild-type HR+ breast cancer patients. This novel mTOR inhibitor-based regimen may address the unmet need in CDK4/6i-failed HR+/HER2- advanced breast cancer."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • AKT1 • HER-2 • PIK3CA • PTEN

Comparative Adherence to Adjuvant Hormonal Therapy and Associated Mortality in Male and Female Veterans with Breast Cancer: A Nationwide Cohort Analysis (SABCS 2025) - "Veterans diagnosed with breast cancer and prescribed adjuvant hormone therapy (tamoxifen,anastrozole, letrozole, or exemestane) between January 1, 2005, and December 31, 2019,were included. Adherence to hormone therapy significantly improves survival outcomes among veterans with breast cancer. While male veterans demonstrated higher adherence rates, gender was not independently associated with adherence after adjustment. Targeted interventions addressing adherence disparities—particularly among younger, Black, divorced/widowed individuals,and patients with uncertain staging—could improve outcomes and reduce health disparities."

Adherence • Clinical • Breast Cancer • Male Breast Cancer • Oncology • Solid Tumor

Deciparticle™ Everolimus (Sapu003): From Cytostasis to Cytotoxicity via a Single mPEG Polymer and Clinic-Ready Manufacturing (SABCS 2025) - "Background: Everolimus is approved for advanced renal-cell carcinoma following VEGF-targeted therapy, for metastatic HR-positive/HER2-negative breast cancer in combination with exemestane, and for other oncology indications...VT111 and its variants were able to formulate both peptides and polyketides, including Everolimus, Sirolimus, Tacrolimus, and Cyclosporine.Manufacturing: Clinical lots were produced using a 7-day process at our cGMP facility...In the glycolysis-dependent U-87 model, Sapu003 was cytotoxic and outperformed paclitaxel, without inducing body weight loss. We screened a 38-member mPEG-block polymer library for self-assembling capacity and identified a leading candidate, VT111, which reproducibly formed stable Deciparticles™ under 20 nm in mean particle diameter and demonstrated potent antitumor activity across multiple xenograft models. We screened a 38-member mPEG-block polymer library for self-assembling capacity and identified a leading candidate,..."

Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • HER-2

Neoadjuvant pyrotinib, trastuzumab, dalpiciclib, and exemestane in triple-positive breast cancer: a multicenter phase II trial (SABCS 2025) - "The NA-PHER2 study demonstrated the potential benefit of a chemotherapy-free regimen, trastuzumab, pertuzumab, palbociclib, and fulvestrant, in TPBC...In the phase II MUKDEN 01 trial, pyrotinib combined with dalpiciclib and letrozole showed promise in TPBC, though efficacy remains suboptimal... This chemotherapy-free, quadruple-targeted neoadjuvant regimen demonstrated promising activity and manageable toxicity in early-stage TPBC. These data support further evaluation of this regimen as a potential alternative to standard chemotherapy-based neoadjuvant approaches in TPBC."

Clinical • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • PGR

Feasibility of Telemonitoring of Personalized Circadian Rhythms in Patients with Early-Stage HR-Positive Breast Cancer Receiving Endocrine Therapy (SABCS 2025) - "All pts were on endocrine monotherapy: 5 anastrozole, 2 tamoxifen, 2 letrozole, and 2 exemestane. Telemonitoring of circadian rhythms using wearable sensors is feasible and well-tolerated in patients receiving ET for HR+ breast cancer. Preliminary data suggest excellent patient adherence and feasibility of such telemonitoring approach, as well as increased ET-related symptoms and sleepiness in the "late" as compared to "early" ET groups. Further analysis will explore circadian rhythm metrics and associations with ET-related symptom burden."

Clinical • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Identifying Premenopausal Patients with Early-Stage Hormone Receptor-Positive Node-Negative Breast Cancer at Minimal Risk of Distant Recurrence by Breast Cancer Index (SABCS 2025) - "Here, we evaluated the prognostic performance of the adjusted BCI model in premenopausal patients with HR+ N0 breast cancer in the SOFT and TEXT trials; the median follow-up was 12 and 13 years, respectively. The analysis included 1110 N0 patients from SOFT (N = 383 assigned tamoxifen; N = 727 assigned exemestane+OFS or tamoxifen+OFS), of whom 70 experienced DR; and 915 N0 patients from TEXT (assigned exemestane+OFS or tamoxifen+OFS), of whom 64 had DR. This study confirms the prognostic ability of the adjusted BCI model to identify a subset of premenopausal patients whose estimated 10-year risk of DR was <5%. Thesefindings provide clinicians and premenopausal patients with additional information for discussions about potential benefits and side effects of adjuvant endocrine therapy regimens."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Survivor plots for quantitated adjunctive statistically standardized ER, PgR, and HER2 in adjuvant postmenopausal breast cancer: Canadian Cancer Trials Group MA.27 trial of exemestane versus anastrozole (SABCS 2025) - P3 | "Survivor plots adjusted for baseline demographic and clinical characteristics provided similar indications of significance for standardized ER, PgR, and HER2 as those seen in multivariable models with both log-normal and Cox survival analyses. Higher PgR was associated with significantly better DDFS."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

An Exploratory Clinical Trial of CDK4/6 Inhibitor Dalpiciclib Combined with Aromatase Inhibitors as Neoadjuvant Therapy for Stage II-III HR-positive HER2-negative Breast Cancer (SABCS 2025) - "Participants receive dalpiciclib 150 mg/d (d1-21 every 28 days) + AIs (letrozole 2.5 mg/d, anastrozole 1 mg/d, or exemestane 25 mg/d); premenopausal women add ovarian suppression (goserelin/leuprolide). Conclusion Dalpiciclib combined with AIs demonstrates promising efficacy and manageable toxicity as neoadjuvant therapy for stage II-III HR+/HER2- breast cancer, offering a new chemotherapy-free option. Future research should focus on biomarker-guided patient selection, long-term outcomes assessment, and comparative trials with other neoadjuvant therapies, aiming to improve the treatment paradigm for HR+/HER2- breast cancer."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Evaluating weight loss outcomes in patients with hormone receptor-positive breast cancer on endocrine therapy receiving concurrent weight loss medications (SABCS 2025) - "ET at weight loss medication initiation: anastrozole (n=17); exemestane (n=3), letrozole (n=2), fulvestrant (n=1); tamoxifen (n=1). The use of GLP-1 RAs or phentermine in this cohort of patients with HR+ BC on ET was associated with meaningful weight loss, most notably within the first nine months, with weight plateauing thereafter. The degree of weight loss observed was comparable to outcomes reported in the general population using these medications. Limitations include a small sample size and grouping of all weight loss agents together."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Circulating Tumour DNA (ctDNA) Dynamics From Patients With ER+, HER2- Advanced Breast Cancer in the Phase 3 EMBER-3 Trial (SABCS 2025) - "Background: The EMBER-3 trial, which included patients with ER+/HER2- advanced breast cancer previously treated with endocrine therapy (ET), demonstrated a significant improvement in progression-free survival (PFS) with imlunestrant (imlu) over standard ET (SOC ET, fulvestrant or exemestane) in patients with ESR1 mutations (ESR1m). Analyses of early ctDNA dynamics from EMBER-3 demonstrated greater early ctDNA reduction with imlunestrant compared with SOC ET in patients with ESR1m. The addition of abemaciclib to imlunestrant enhanced ctDNA decline in all patients, consistent with the primary study outcomes. Furthermore, while a ≥50% decline in ctDNA at C2D21 was associated with improved PFS, the allocated treatment remained a key determinant of patient outcomes."

Circulating tumor DNA • Clinical • Metastases • P3 data • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Impact of prior CDK 4/6 inhibitor treatment on the efficacy of everolimus and exemestane or fulvestrant in hormone receptor positive HER 2 negative (HR+/HER2-) metastatic breast cancer (MBC): a restrospective analysis of 144 patients. (SABCS 2025) - "Two cohorts were compared: cohort 1 without previos CDK 4/6 inhibitor and cohort 2 with previous CKD4/6 inhibitor (palbociclib or ribociclib). Clin Breast Cancer. 2022 Feb; 22(2):143-148."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Impact of Glucagon-like peptide-1 receptor agonists Use on Survival and Metabolic Outcomes in Metastatic Estrogen Receptor Positive Breast Cancer: A Real-World Cohort Study (SABCS 2025) - "Two cohorts were defined: (1) ER+ MBC patients treated with GLP-1a (tirzepatide, dulaglutide, semaglutide, or liraglutide) and aromatase inhibitors (letrozole, anastrozole, or exemestane), excluding metformin users; and (2) ER+ MBC patients treated with aromatase inhibitors without GLP-1a or metformin. This large retrospective cohort analysis provides evidence suggesting that GLP-1a use in patients with ER+ metastatic breast cancer may offer survival benefits beyond their established metabolic indications. The association between GLP-1a use and improved two-year overall survival, as well as reduced hospitalizations and lower incidence of several treatment-related adverse events, is clinically significant and suggests a possible dual role for GLP-1a in addressing both metabolic and oncologic challenges in this population. Importantly, GLP-1a therapy was not associated with increased gastrointestinal or cardiac toxicity, reinforcing its safety profile when used alongside..."

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER

Chidamide combined with fulvestrant in the treatment of HR-positive,HER2-negative advanced breast cancer after failure of previous endocrine therapy: A single-arm, single-center, phase 2 study (SABCS 2025) - "The ACE study demonstrated that chidamide combined with exemestane significantly improved progression-free survival compared to placebo plus exemestane in patients with advanced, hormone receptor-positive(HR-positive), HER2-negative (HER2-) breast cancer who had experienced disease progression following prior endocrine therapy. Chidamide combined with fulvestrant demonstrated promising antitumor efficacy and manageable toxicity in patients with HR+/HER2- advanced breast cancer who experienced disease progression following prior endocrine therapy."

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Evaluating all-cause mortality and endocrine therapy tolerability with sodium glucose cotransporter-2 inhibitors in hormone receptor-positive breast cancer: A real-world analysis (SABCS 2025) - "Methodology: We conducted a real-world analysis using the TrinetX database, which includes data from 184 million patients in 156 healthcare organizations, to identify BC patients on ET (letrozole, anastrozole, exemestane, tamoxifen) who received SGLT-2 inhibitors vs. those who did not. This analysis reveals novel evidence supporting the cardiometabolic potential of SGLT-2 inhibitors in hormone receptor-positive BC, particularly postmenopausal populations. These agents were linked to lower all-cause mortality and improved tolerance of specific ET-related effects. However, certain adverse risks require caution."

Clinical • Real-world • Real-world evidence • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor