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• W4361947425 abstract "<div>AbstractPurpose:<p>Preclinical data demonstrating androgen receptor (AR)–positive (AR⁺) triple-negative breast cancer (TNBC) cells are sensitive to AR antagonists, and PI3K inhibition catalyzed an investigator-initiated, multi-institutional phase Ib/II study TBCRC032. The trial investigated the safety and efficacy of the AR-antagonist enzalutamide alone or in combination with the PI3K inhibitor taselisib in patients with metastatic AR⁺ (≥10%) breast cancer.</p>Patients and Methods:<p>Phase Ib patients [estrogen receptor positive (ER⁺) or TNBC] with AR⁺ breast cancer received 160 mg enzalutamide in combination with taselisib to determine dose-limiting toxicities and the maximum tolerated dose (MTD). Phase II TNBC patients were randomized to receive either enzalutamide alone or in combination with 4 mg taselisib until disease progression. Primary endpoint was clinical benefit rate (CBR) at 16 weeks.</p>Results:<p>The combination was tolerated, and the MTD was not reached. The adverse events were hyperglycemia and skin rash. Overall, CBR for evaluable patients receiving the combination was 35.7%, and median progression-free survival (PFS) was 3.4 months. Luminal AR (LAR) TNBC subtype patients trended toward better response compared with non-LAR (75.0% vs. 12.5%, <i>P</i> = 0.06), and increased PFS (4.6 vs. 2.0 months, <i>P</i> = 0.082). Genomic analyses revealed subtype-specific treatment response, and novel <i>FGFR2</i> fusions and AR splice variants.</p>Conclusions:<p>The combination of enzalutamide and taselisib increased CBR in TNBC patients with AR⁺ tumors. Correlative analyses suggest AR protein expression alone is insufficient for identifying patients with AR-dependent tumors and knowledge of tumor LAR subtype and AR splice variants may identify patients more or less likely to benefit from AR antagonists.</p></div>" @default.
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• W4361947425 date "2023-03-31" @default.
• W4361947425 modified "2023-10-14" @default.
• W4361947425 title "Data from TBCRC 032 IB/II Multicenter Study: Molecular Insights to AR Antagonist and PI3K Inhibitor Efficacy in Patients with AR⁺ Metastatic Triple-Negative Breast Cancer" @default.
• W4361947425 doi "https://doi.org/10.1158/1078-0432.c.6529968" @default.
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