Yvette C. Terrie

DocwireNews

Findings from the phase II UCBG 3-06 START trial (Study on Androgen Receptor and Triple Negative Breast Cancer) recently published in <a href="https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00737-X/fulltext" target="_blank" rel="noopener">The Lancet Oncology</a> revealed that treatment with the anti-androgen darolutamide did not achieve the clinical benefit endpoint in patients with triple-negative, androgen receptor (AR)-positive advanced breast cancer.Herve Bonnefoi, MD, from the Department of Medical Oncology, Breast Unit, Institute Bergoni&eacute;, in France, and colleagues wrote, &ldquo;We proposed in 2005 that androgens replace oestrogens as the driver steroids in a subgroup of triple-negative breast cancer (TNBC) with androgen receptor (AR) expression called molecular apocrine (MA) or luminal androgen receptor (LAR). Here, we report the analysis of a clinical trial evaluating the antitumour activity of the anti-androgen darolutamide in MA breast cancer.&rdquo;The trial sought to evaluate the clinical benefit in patients diagnosed with AR-positive triple-negative breast cancers (TNBCs), as determined by immunohistochemistry and RNA profiling.In the non-comparative multicenter trial, 90 eligible women with TNBC AR-positive breast cancer were randomly assigned 2:1 to darolutamide (600 mg twice daily, n=58) or capecitabine (1,000 mg/m&sup2; twice daily for 2 weeks on and 1 week off, n=32) until disease progression or toxicity, lack of follow-up, or termination of consent.The researchers categorized tumors into groups with high and low AR activity (MA-high and MA-low) employing transcriptomic analysis.The primary endpoint was the clinical benefit rate at 16 weeks and to demonstrate at least a 40% rate in the darolutamide group.At 16 weeks, clinical benefit was observed in 29% (darolutamide) and 59% (capecitabine). MA-high tumors responded better to darolutamide (57%) compared to MA-low tumors (16%) (P=0.0020).The most common grade 3 adverse events included headache (5%) in the darolutamide group and palmar-plantar erythrodysesthesia (6%) in the capecitabine group, with no grade 4 or 5 events. Drug-associated serious adverse events were reported as 5% and 9% for the darolutamide and capecitabine groups, respectively.&ldquo;This study did not reach its prespecified endpoint for darolutamide activity in patients with triple-negative breast cancer selected on the basis of immunohistochemistry for AR. Further studies selecting patients based on RNA profiling might allow better identification of tumors sensitive to antiandrogens,&rdquo; concluded the authors.<h3>Reference</h3>Bonnefoi H, et al. Lancet Oncol. 2025 Mar;26(3):355-366. doi: 10.1016/S1470-2045(24)00737-X.

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Lancet Study: Darolutamide Shows No Clinical Benefit in AR+ Triple-Negative Breast Cancer

Triple-Negative Breast Cancer

Darolutamide did not meet the clinical benefit endpoint in AR-positive TNBC, per findings from the phase II START trial.

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