Obesity was associated with lower ORR with letrozole alone, whereas this association was not observed in patients treated with taselisib.

P1, N=30, Not yet recruiting, Northwestern University | N=75 --> 30

Despite aggressive critical care management, she experienced cardiac arrest and died. This case may represent the first reported fatal occurrence of anastrozole-associated TLS in advanced breast cancer, underscoring the need for vigilance for TLS even with hormonal agents traditionally considered low-toxicity.

The present study evaluated berberine-gallic acid (BBR-GAL) and berberine-gentisic acid (BBR-GEN) using an integrated in silico and in vivo approach in a letrozole-induced PCOS mouse model...By restoring hepatic insulin signaling through modulation of the adenosine monophosphate-activated protein kinase-insulin receptor substrate-1/phosphatidylinositol 3-kinase/protein kinase B axis and attenuating ovarian inflammation, these formulations provide mechanistic validation for improved therapeutic efficacy. These findings indicate that crystal-engineered BBR could be a useful approach in improving the endocrine-metabolic phenotypes of preclinical PCOS.

Therefore, this study investigates the ameliorative effects of total flavonoids from Rubus chingii Hu (RHF) on HPO axis function and inflammatory response in a rat model of PCOS induced by letrozole...In ovarian tissue, RHF downregulated the protein and mRNA expression of NLRP3, caspase-1, the N-terminal fragment of gasdermin D (GSDMD-NT), IL-18, and IL-1β, and lowered the mRNA levels of IL-6 and TNF-α, thereby attenuating both systemic and local ovarian inflammatory responses. Taken together, these findings demonstrate that RHF confers protective effects in PCOS rats, which are associated with the amelioration of HPO axis function and suppression of inflammatory responses.

P=N/A, N=400, Completed, Sohag University

We investigated whether DHED could prevent side effects associated with the aromatase inhibitor letrozole in a primate model of aging...Here, we show that a brain-selective estrogen therapy administered orally via the prodrug DHED substantially increases estrogen levels in the marmoset brain without affecting the periphery and normalizes impairments in working memory, hippocampal neuronal excitability and sleep induced by aromatase inhibition. These findings in a translational primate model represent a significant advance for women's health by positioning DHED as a non-invasive, safe and efficient novel hormone therapy to improve quality of life of women with ER+ breast cancers.

P3, N=309, Recruiting, University of California, San Francisco | Trial completion date: Mar 2026 --> Mar 2028 | Trial primary completion date: Mar 2026 --> Mar 2028

P4, N=62, Terminated, University of Washington | Recruiting --> Terminated; Study ended earlier than anticipated due to end of funding.

P2, N=70, Not yet recruiting, Kafrelsheikh University

MBR-01 may effectively mitigate abemaciclib-induced diarrhea, likely through the achievement of stabilization of gut microbiota composition. Larger prospective studies are warranted to validate these preliminary findings.

P3, N=200, Completed, Beni-Suef University | N=500 --> 200 | Trial completion date: Dec 2024 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Mar 2026 | Not yet recruiting --> Completed