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A new drug for early breast cancer is easier on patients than the current standard. Phase 3 trial data show that giredestrant maintained physical functioning and caused less joint pain than standard endocrine therapy in ER+, HER2– early breast cancer, while also cutting the risk of disease recurrence by 30%. The FDA is already reviewing a new drug application, with a decision expected by November 2026.
Giredestrant, an oral selective estrogen receptor degrader (SERD), isn't just more effective than standard endocrine therapy in early breast cancer — it's also better tolerated. Patient-reported outcome (PRO) data from the phase 3 lidERA Breast Cancer trial, presented at the 2026 ESMO Congress, show that patients on giredestrant maintained physical functioning, role functioning, and overall health-related quality of life over more than three years of treatment, with no clinically meaningful decline in either arm.
Crucially, fewer patients on giredestrant reported frequent or near-constant joint pain compared to those on standard-of-care (SOC) endocrine therapy — a common reason patients stop hormone therapy early. Hot flash and fatigue profiles were similar between the two groups. These findings complement the trial's primary results, which showed giredestrant reduced the risk of invasive disease recurrence or death by 30% vs. SOC.
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Why it matters: Better tolerability means patients are more likely to stay on therapy — a critical factor in preventing recurrence. With an FDA decision expected by November 30, 2026, giredestrant could soon become the first oral SERD approved in the curative early breast cancer setting.