anastrozole

P2, N=200, Recruiting, Oana Danciu | Trial completion date: Dec 2027 --> Aug 2029 | Trial primary completion date: Dec 2024 --> Aug 2028

P3, N=463, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2024 --> Jan 2026

Hormonal or endocrine therapy includes selective estrogen receptor modulators (SERMs) such as raloxifene, tamoxifen and toremifene, selective estrogen-receptor degraders (SERDs) including elacestrant and fulvestrant, and aromatase inhibitors such as anastrozole, letrozole, and exemestane...These agents include taxanes (docetaxel, nab-paclitaxel, and paclitaxel), anthracyclines (doxorubicin, epirubicin), anti-metabolites (capecitabine, gemcitabine, fluorouracil, methotrexate), alkylating agents (carboplatin, cisplatin, and cyclophosphamide), and drugs that target microtubules (eribulin, ixabepilone, ado-trastuzumab emtansine). Patients with ER-positive tumors are treated with 5-10 years of endocrine therapy and chemotherapy. For patients with metastatic breast cancer, standard first-line and follow-up therapy options include targeted approaches such as CDK4/6 inhibitors, PI3K inhibitors, PARP inhibitors, and anti-PDL1 immunotherapy, depending on the tumor type and molecular profile.

Cyclin D-dependent kinase 4/6 inhibitors palbociclib, ribociclib and abemaciclib, in combination with aromatase inhibitors anastrozole and letrozole or oestrogen receptor degrader fulvestrant, are being assessed as candidates for therapeutic drug monitoring. DLLME proved to be the most ecologically acceptable method due to the high degree of miniaturisation (AGREEprep score 0.44), PLR enabled very high sample throughput and cost-effectiveness (BAGI 72.5), while SPE showed the best analytical performance (redness score 100). All three methods are suitable for their designated purpose, and the choice of the ideal method can be made based on the scope of application, available funds and equipment and desired ecological footprint.

P3, N=3832, Not yet recruiting, Region Örebro County | Initiation date: May 2024 --> Jan 2025

Introduction The INGE-B trial (NCT02894398) aimed to confirm the efficacy and safety data from the PALOMA trials for patients treated first line (1L) with palbociclib (PAL) and letrozole or 1L and later line with PAL and fulvestrant. Conclusion The INGE-B trial demonstrated good efficacy and tolerability of PAL with letrozole (1L) or fulvestrant (first and later line) in accordance with the PALOMA-trials. In addition, the so far lacking proof of efficacy and safety of PAL in combination with anastrozole or exemestane in 1L and with letrozole in later line was provided by INGE-B.

In contrast, anastrozole and letrozole show lower binding affinities for HER2 and EGFR due to their simpler structures but are potent aromatase inhibitors, making them effective in treating estrogen receptor-positive (ER-positive) breast cancers. In conclusion, DFT and molecular docking studies affirm the suitability of lapatinib, tucatinib, and neratinib for HER2-positive cancers, while anastrozole and letrozole are effective in ER-positive cancers, emphasizing the role of molecular structure and binding affinity in optimizing cancer treatment strategies.

P2, N=90, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2026 --> Jun 2025

P3, N=1156, Not yet recruiting, Alliance for Clinical Trials in Oncology

Here we report the primary endpoint of complete cell cycle arrest (CCCA) and correlative studies of the NeoPalAna (NCT01723774) ET-R Cohort to examine resistance biomarkers for palbociclib (PAL) + anastrozole (ANA). Specific oncogenic pathways and immune tolerance markers, such as IDO1, were enriched in PAL-R. Our data also suggest immune modulatory effects of CDK4/6i/ET in association with ET/PAL response.

Eligible pts (n=81) will undergo baseline (BL) breast MRI and tumor/blood collection, followed by a 28-day cycle of anastrozole (ana) (+/- 14 days, C1), during which BC risk category will be determined based on BL tumor Ki67 and study-funded Prosigna(R) PAM50 subtype...If responses are observed in ≥16 pts among 23 ORR evaluable pts, the trial claims preliminary efficacy. The study is actively enrolling pts at Siteman Cancer Center.

In 1 pt, eribulin and abraxane did not have the same effect; ESR1 polyclonality was maintained. One pt with 1 ESR1 clone after 2.5 years of fulvestrant+palbociclib developed 15 additional clones after 1.5 years of an experimental SERD+everolimus. Another pt with 1 ESR1 clone after anastrozole+palbociclib developed 9 additional ESR1 clones after 10 months of AKT inhibition+anastrozole... This is the first investigation of dynamic changes in extreme ESR1 polyclonality in association with treatment outcomes in pts with ER+ MBC. Capecitabine was associated with a decrease in detectable ESR1-mutant clones, while increased polyclonality was found at progression on SERD+everolimus, AKT-inhibitor+AI, and an ADC. Although extreme ESR1 polyclonality is rare, understanding mutational dynamics will improve our understanding of polyclonality more broadly and its impact on treatment resistance.

Methods Pre/perimenopausal pts with no prior systemic therapy for aggressive HR+/HER2− ABC were randomized 1:1 to RIB + letrozole/anastrozole + goserelin or physician's choice of combo CT. Contrary results in the CT arm suggest that these signatures warrant further studies on their potential predictive value. These data are hypothesis generating and should be interpreted with caution due to small sample sizes.

P2, N=200, Recruiting, Oana Danciu | Active, not recruiting --> Recruiting

P3, N=4220, Recruiting, Stemline Therapeutics, Inc. | Not yet recruiting --> Recruiting

With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups. Observed adverse events remained stable.

P2, N=376, Completed, Novartis Pharmaceuticals | Active, not recruiting --> Completed

P4, N=137, Recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2030 --> Feb 2028 | Trial primary completion date: Feb 2030 --> Jan 2028

P2, N=48, Recruiting, Ruth O'Regan | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Sep 2024 --> Sep 2025

Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.

P3, N=500, Recruiting, AstraZeneca | Trial completion date: Jul 2030 --> Oct 2030

P=N/A, N=232, Completed, University of Colorado, Denver | Active, not recruiting --> Completed | N=379 --> 232

P3, N=493, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2024 --> Dec 2025

P3; Active, not recruiting --> Completed

P3, N=312, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P2, N=200, Active, not recruiting, Oana Danciu | Recruiting --> Active, not recruiting

P2, N=34, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Apr 2025 --> Sep 2024 | Trial primary completion date: Apr 2025 --> Sep 2024

P2, N=60, Suspended, University of Washington | Recruiting --> Suspended

P1/2, N=402, Active, not recruiting, Sihuan Pharmaceutical Holdings Group Ltd. | Recruiting --> Active, not recruiting | N=300 --> 402 | Trial completion date: Dec 2022 --> Dec 2025

P3, N=180, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Jun 2025

These findings, supported by molecular docking scores and MM-PBSA binding energies, advocate for their potential superior inhibitory capability against the AKT1 enzyme. Nevertheless, it is crucial to validate these computational predictions through in vitro and in vivo studies to thoroughly evaluate the therapeutic potential and viability of these compounds for AKT1-targeted breast cancer treatment.

P2, N=37, Active, not recruiting, Medical College of Wisconsin | Trial completion date: Jul 2024 --> Mar 2025

The recommended phase III dose of dalpiciclib was 150 mg. ClinicalTrials.gov identifier: NCT03481998.

P1, N=193, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting | N=400 --> 193

P2, N=152, Completed, Arvinas Inc. | Active, not recruiting --> Completed

P2, N=201, Completed, Priscilla McAuliffe | Active, not recruiting --> Completed

P3, N=500, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Aug 2024

P2, N=83, Active, not recruiting, Shayna Showalter, MD | Trial primary completion date: Mar 2024 --> Jun 2024

Clinical and pathological responses will be measured overall and in the luminal tumor A subgroup. Toxicity, health-related quality of life, and circulating biomarkers predicting early NET response will also be evaluated.

Beneficiaries who initiated tamoxifen, anastrozole, letrozole, or exemestane within 3 months after cancer diagnosis were defined as initiators (n = 24,289), and those who never initiated these treatments were noninitiators (n = 8,899). ET initiation and adherence was associated with reduced risk of all-cause (adjusted HR = 0.62, 0.59-0.66; HR = 0.55, 0.53-0.59; respectively) and breast cancer related (adjusted HR = 0.57, 0.50-0.64; HR = 0.41, 0.36-0.47; respectively) mortality compared with noninitiators. Women with early-stage breast cancer who initiate ET and are adherent to treatment may achieve survival benefits compared with noninitiators.

P3, N=250, Recruiting, Tolmar Inc. | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026

P=N/A, N=90, Recruiting, University of Maryland, Baltimore | Trial primary completion date: Mar 2024 --> Jul 2024