Giredestrant Beats Standard Endocrine Therapies Irrespective of Menopausal Status in Patients with ER+, HER2- Early Breast Cancer
An interview with:
Peter Schmid MD PhD, Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre, Queen Mary University of London
CHICAGO, USA—Although endocrine therapy with the selective estrogen receptor degrader giredestrant has recently been found efficacious, safe and potentially superior to standard of care in postmenopausal patients who have ER positive, HER2 negative early breast cancer, its value for treating pre-menopausal patients remained to be established.
But at the American Society of Clinical Oncology 2026 new data from the phase 3 lidERA BC trial found that it’s superiority was irrespective of menopausal status.
First author of the study, Peter Schmid MD PhD, Professor of Cancer Medicine; Centre Lead, Centre of Experimental Cancer Medicine; Director, Barts Breast Cancer Centre, Queen Mary University of London spoke with the Audio Journal of Oncology:
AUDIO JOURNAL OF ONCOLOGY: Peter Schmid MD PhD
IN: [GOODWIN]” ….I am here at ….
OUT: …..of Oncology, I’m Peter Goodwin 8:29
ASCO 2026 Abstract # 502
Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor–positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the phase III lidERA BC clinical trial: Results by menopausal status.
Authors: Peter Schmid, Charles E. Geyer Jr., Miguel Martin, Sara A. Hurvitz, Kyung Hae Jung, Mothaffar Rimawi, Shigehira Saji, Gustavo Werutsky, Nadia Harbeck, Sherene Loi, Ernesto P. Korbenfeld, Isabel Blancas, Chi-Feng Chung, Rena D. Callahan, Meilin Huang, Miranda Craft, Mona D. Shah, Tanja Badovinac Crnjevic, Pablo D. Pérez- Moreno, Aditya Bardia
Organizations: Queen Mary University of London, London, United Kingdom, University of Pittsburgh School of Medicine and UPMC Hillman Cancer Center, Pittsburgh, PA, CIBERONC, Universidad Complutense, GEICAM, Madrid, Spain, Fred Hutch Cancer Center, Seattle, WA, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, Baylor College of Medicine, Houston, TX, Fukushima Medical University, Fukushima, Japan, Latin American Cooperative Oncology Group and Centro de Pesquisa em Oncologia Hospital Sao Lucas PUCRS, Porto Alegre, Brazil, LMU University Hospital, Munich, Germany, Peter MacCallum Cancer Centre and The Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Melbourne, Australia, Hospital Británico de Buenos Aires, Buenos Aires, Argentina, Hospital Clínico San Cecilio de Granada, Granada, Spain, Koo Foundation Sun Yat-Sen Cancer Center, Taipei City, Taiwan, UCLA David Geffen School of Medicine, Los Angeles, CA, Genentech, Inc., South San Francisco, CA, F. Hoffmann-La Roche Ltd, Basel, Switzerland, University of California, Los Angeles, Los Angeles, CA
Background:
The lidERA BC trial (NCT04961996) demonstrated a statistically significant, clinically meaningful improvement in invasive disease-free survival (IDFS) with GIRE (a next-generation oral SERD and full ER antagonist) vs standard-of-care endocrine therapy (SOC ET) in ER+, HER2–, Stage I–III eBC (Bardia SABCS 2025). We report efficacy and safety in pre-menopausal (PRE-M) vs post- menopausal (POST-M) pts.
Methods:
Pts with ER+, HER2– eBC who had BC surgery and (neo)adjuvant chemotherapy (if indicated) were randomized 1:1 to once-daily 30 mg GIRE or SOC ET (anastrozole/letrozole/exemestane [aromatase inhibitors; AIs] or tamoxifen [TAM]) for 5 years (y) of treatment (tx). PRE-M pts on
GIRE and on AIs received an LHRH.
Results:
In the efficacy-evaluable population (n = 4170), 40.7% of pts were PRE-M and 59.3% POST-M. 58.0% of pts on TAM received LHRH. PRE-M pts generally had a slightly higher baseline risk of recurrence vs POST-M pts (high risk, 70.5% vs 66.4%; medium risk, 28.4% vs 32.5%; higher use of [neo]adjuvant chemotherapy, 91.2% vs 78.9%). GIRE showed IDFS benefit and higher 3-y rates in both PRE-M and POST-M subgroups; a similar trend was observed for distant recurrence-free interval (DRFI) (Table). Adverse events (AE) were comparable in both subgroups and across txs (Table). Fewer pts discontinued GIRE due to AEs compared with pts receiving an AI, regardless of menopausal status. Discontinuation due to musculoskeletal pain occurred in 1.6% vs 4.5% of pts receiving GIRE vs AI, respectively. More pts switched to alternative ET in the SOC ET arm vs GIRE (10.1% vs 5.7%), mainly due to AEs for both arms.
Conclusions:
Adjuvant GIRE improved IDFS and DRFI vs SOC ET; benefit was consistent irrespective of menopausal status. PRE-M pts experienced a 42% reduction in the risk of developing metastatic disease and POST-M pts a 24% reduction. Safety was comparable between menopausal groups and there were few discontinuations, regardless of menopausal status, although PRE-M and POST-M pts receiving GIRE had fewer tx discontinuations than those receiving an AI or TAM in the PRE-M and POST-M settings.
HRs are unstratified vs SOC ET. *Includes other related terms.
Research Funding:
- Hoffmann-La Roche Ltd
Track:
Breast Cancer—Local/Regional/Adjuvant
Clinical Trial Registration Number:
NCT04961996
Citation:
J Clin Oncol 44, 2026 (suppl 16; abstr 502)
DOI:
10.1200/JCO.2026.44.16_suppl.502
Abstract Disclosures:
Disclaimer:
This material on this page is ©2026 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact [email protected]
260605 Peter Schmid, ASCO 2026 A J Oncology TEXT
June 5, 2026
