Disease-free survival improvement with adjuvant giredestrant in breast cancer

Results from lidERA phase III trial, recently presented at the San Antonio Breast Cancer Symposium, show that adjuvant giredestrant, an investigational, oral selective estrogen receptor degrader (SERD), significantly improved invasive disease-free survival compared (iDFS) compared with the current standard-of-care endocrine therapy in patients with early-stage, hormone receptor (HR)-positive, HER2-negative breast cancer.

LidERA trial is randomised, open-label, multicentre phase III study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in over 4100 patients with medium- or high-risk stage I-III HR+/HER2- breast cancer. All the patients had received surgery and, if indicated, completed adjuvant or neoadjuvant chemotherapy; they were randomized to receive either 30 mg of giredestrant or one of four standard-of-care endocrine therapies (tamoxifen, letrozole, anastrozole, or exemestane). At the pre-specified interim analysis after a median follow-up of 32.3 months, patients who received giredestrant had significantly better iDFS than their counterparts who received standard-of-care endocrine therapy; indeed, they were 30% less likely to develop iDFS at the time of follow-up and they were also 31% less likely than those in the standard-of-care arm to experience distant recurrence at the time of follow-up. Preliminary overall survival data showed a benefit too, with a clear positive trend, with a manageable safety profile. Aditya Bardia from the Los Angeles Jonsson Comprehensive Cancer Center, who presented the data, said: «For more than a quarter of a century, tamoxifen and aromatase inhibitors have remained the standard endocrine therapy option for patients with early breast cancer. Results from lidERA demonstrate clinical superiority of giredestrant to tamoxifen and aromatase inhibitors, placing giredestrant as a new standard in endocrine therapy for patients with early-stage, HR-positive, HER2-negative breast cancer».