exemestane

Although tucidinostat in combination with exemestane had produced a clinically meaningful and statistically significant improvement in the primary endpoint PFS, the ACE study did not show a prolongation of the secondary endpoint OS in the tucidinostat combination regimen. Ongoing studies have been considered in terms of potential identification of what patient subpopulations could benefit most from the tucidinostat combination regimens in advanced HR+ breast cancer.

P=N/A, N=779, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: May 2024 --> Jan 2024 | Trial primary completion date: May 2024 --> Jan 2024

P3; Trial completion date: Mar 2024 --> Oct 2032

P2, N=30, Completed, Johns Hopkins University | Active, not recruiting --> Completed

This retrospective analysis cohort of everolimus plus ET in mBC patients previously treated with a CDK4/6 inhibitor suggests a longer estimated mPFS when compared with the mPFS with ET monotherapy obtained from current randomized clinical data. Everolimus plus ET may be considered as a valid control arm in novel clinical trial designs.

P2, N=37, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended

P2, N=247, Active, not recruiting, Pfizer | Trial completion date: Dec 2023 --> Jun 2024

P3, N=500, Not yet recruiting, AstraZeneca

P3, N=3100, Suspended, Novartis Pharmaceuticals | Recruiting --> Suspended

P2, N=367, Active, not recruiting, Sanofi | Trial completion date: Mar 2024 --> Sep 2024

To the best of our knowledge, we present here for the first time a comprehensive and direct head-to-head, intra-patient-cross-over comparison of the aromatase inhibitor letrozole and the aromatase inactivator exemestane concerning their ability to suppress serum estrogen levels in vivo. All in all, our results clearly demonstrate that letrozole therapy results in a more profound suppression of serum E1 and E2 levels compared to exemestane.

P2, N=90, Recruiting, UNC Lineberger Comprehensive Cancer Center | Trial completion date: May 2025 --> Apr 2032 | Trial primary completion date: May 2024 --> Apr 2027

P2, N=257, Completed, Palleos Healthcare GmbH | Active, not recruiting --> Completed

P2, N=160, Not yet recruiting, Andrea DeCensi

These real-life data show that everolimus in combination with AI in patients with HER2-negative, HR-positive advanced breast cancer is an effective treatment with an acceptable toxicity profile.

Studies using anastrozole (ANA), exemestane (EXE), letrozole (LET), and tamoxifen (TMX) were involved. Our results suggest that, despite statistically significant results, EXE and LET may not be sufficient to cause severe dyslipidemia in patients without cardiovascular comorbidities according to the AHA/ACC Guideline on the Management of Blood Cholesterol. However, the results may raise the question of monitoring the effects of AIs in patients, especially those with pre-existing cardiovascular risk factors such as dyslipidemia.

P=N/A, N=351, Completed, University Health Network, Toronto | Unknown status --> Completed

P1, N=500, Active, not recruiting, Eli Lilly and Company | Phase classification: P1a/1b --> P1

P2, N=90, Recruiting, Dana-Farber Cancer Institute | Initiation date: Feb 2024 --> Oct 2023

P1, N=198, Active, not recruiting, Eli Lilly and Company | Phase classification: P1b --> P1

Multi-omics data from the phase IIa patients (n = 24 tumor/17 blood biopsy exomes; n = 27 tumor transcriptomes) showed potential mechanisms of resistance (convergent evolution of HER2 activation, BRAFV600E), identified joint genomic/transcriptomic resistance features (ESR1 mutations, high estrogen receptor pathway activity, and a Luminal A/B subtype; ERBB2/BRAF mutations, high RTK/MAPK pathway activity, and a HER2-E subtype), and provided hypothesis-generating results suggesting that mTOR pathway activation correlates with response to the trial's therapy. Our results illustrate how genome and transcriptome sequencing may help better identify patients likely to respond to CDK4/6i therapies.

P2, N=1008, Recruiting, Fudan University | Not yet recruiting --> Recruiting

P2, N=30, Completed, City of Hope Medical Center | Active, not recruiting --> Completed

P2, N=60, Not yet recruiting, University of Washington | Trial completion date: Mar 2025 --> Jun 2026

P=N/A, N=2683, Active, not recruiting, Novartis Pharmaceuticals

P1, N=50, Recruiting, Finn, Olivera, PhD | Not yet recruiting --> Recruiting | Trial completion date: Jul 2027 --> Aug 2028

Despite the rate of PEPI score 0 was not high, tucidinostat plus exemestane as a neoadjuvant therapy might be well tolerated and showed promising clinical responses in patients with early hormone receptor-positive, HER2-negative breast cancer. To clarify the safety and efficacy of this strategy, further investigation is warranted.

P2, N=105, Completed, Merus N.V. | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Jul 2023

The BRAWO study provides real-world evidence of efficacy and safety of EVE + EXE in patients with HR+, HER2- ABC. A high BMI and the absence of visceral metastases were independent predictors of PFS in this cohort of patients.

P1, N=55, Completed, Tianjin Hemay Pharmaceutical Co., Ltd | Recruiting --> Completed

P3, N=510, Recruiting, Pfizer | Not yet recruiting --> Recruiting

P3, N=5, Terminated, Veru Inc. | N=186 --> 5

P3, N=3100, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P2, N=19, Active, not recruiting, Mayo Clinic | Recruiting --> Active, not recruiting | N=80 --> 19

We have developed and validated this quantitative method for therapeutic drug monitoring of those four hormone therapy drugs:anastrozole, letrozole, fulvestrant and exemestane. This method can be also used for future clinical pharmacokinetics /pharmacodynamics studies.

P2, N=37, Recruiting, National Cancer Institute (NCI) | Initiation date: Oct 2024 --> Feb 2024

P3, N=3100, Not yet recruiting, Novartis Pharmaceuticals | Trial primary completion date: Jul 2028 --> Sep 2029

P3, N=496, Active, not recruiting, Alliance Foundation Trials, LLC. | Trial primary completion date: Dec 2023 --> Apr 2024

P2, N=367, Active, not recruiting, Sanofi | Trial completion date: Dec 2023 --> Mar 2024

P3, N=23, Terminated, Ente Ospedaliero Ospedali Galliera | N=468 --> 23 | Recruiting --> Terminated | Trial primary completion date: Oct 2022 --> Apr 2023; low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment

P=N/A, N=34, Recruiting, Second Affiliated Hospital of Soochow University

This protocol describes a study investigating the feasibility, acceptability, and usability of the symptom management tool Bone@BC developed for patients with breast cancer with an endocrine aspect.