Adjuvant treatment with giredestrant improved invasive disease-free survival and distant recurrence-free survival in women with breast cancer regardless of menopausal status, according to study data presented at the 2026 ASCO Annual Meeting.

Previously published data from the phase 3 lidERA study demonstrated that giredestrant, a next-generation oral selective estrogen receptor antagonist and full estrogen receptor antagonist, significantly improved invasive disease-free survival in patients with estrogen receptor-positive, HER2-negative early breast cancer.

Peter Schmid, MD, PhD, chair of cancer medicine at Barts Cancer Institute, Queen Mary University of London, London, England, conducted a subanalysis based on menopausal status to determine whether the efficacy and safety of giredestrant differed in premenopausal (PRE-M) and postmenopausal (POST-M) patients.

The evaluable study population included 1687 PRE-M patients and 2456 POST-M patients. Schmid and colleagues randomly assigned patients to daily oral giredestrant or standard-of-care endocrine therapy with aromatase inhibitors.

The course of treatment was prescribed for 5 years. Regardless of treatment assignment, PRE-M women also received luteinizing hormone-releasing hormone agonists.

According to the researchers, PRE-M women demonstrated somewhat elevated baseline risks for recurrence compared with POST-M women. Neoadjuvant chemotherapy utilization was also higher among PRE-M women.

The 3-year invasive disease-free survival outcomes favored assignment to giredestrant for both PRE-M women and POST-M women.

Similarly, the researchers observed distant recurrence-free survival trends in favor of giredestrant for PRE-M women and POST-M women. 

In the safety-evaluable population, the researchers observed similar rates of any-grade adverse events and grade 3 or higher adverse events.

Fewer patients assigned to giredestrant discontinued treatment due to adverse events, regardless of menopausal status. Musculoskeletal pain was common in both treatment arms, but fewer patients assigned to giredestrant discontinued treatment due to musculoskeletal pain.

A greater number of patients assigned to the control arm switched to alternative endocrine therapies due to adverse events than those receiving giredestrant.

“PRE-M patients experienced a 42% reduction in the risk of developing metastatic disease and POST-M patients a 24% reduction. Safety was comparable between menopausal groups and there were few discontinuations, regardless of menopausal status, although PRE-M and POST-M patients receiving [giredestrant] had fewer treatment discontinuations than those receiving an [aromatase inhibitor] or [tamoxifen] in the PRE-M and POST-M settings.”

- Peter Schmid, MD, PhD, chair of cancer medicine at Barts Cancer Institute, Queen Mary University of London, London, England

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References:

https://www.asco.org/abstracts-presentations/261559

https://clinicaltrials.gov/study/NCT04961996

Disclosures: Schmid declared financial ties to drugmakers. See abstract for details. F. Hoffmann-La Roche sponsored the lidERA study.

By Cameron Kelsall

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