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Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1
Vaklavas, C. Oliveira, M. Armstrong, A. C. Moreno, I. Twelves, C. Victoria Ruiz, I. Bermejo de Las Heras, B. Brier, T. Ciardullo, C. Gibbons, L.
Vaklavas, C.
Oliveira, M.
Armstrong, A. C.
Moreno, I.
Twelves, C.
Victoria Ruiz, I.
Bermejo de Las Heras, B.
Brier, T.
Ciardullo, C.
Gibbons, L.
Abstract
BACKGROUND: Camizestrant, the next-generation oral selective estrogen receptor degrader and complete estrogen receptor (ER) antagonist, has previously demonstrated superiority over fulvestrant in patients with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Capivasertib is a selective AKT inhibitor recommended with fulvestrant for patients with PIK3CA/AKT1/PTEN-altered ER-positive, HER2-negative advanced breast cancer. Here, we report data from Parts I and J of SERENA-1 (NCT03616587), evaluating the safety, tolerability, pharmacokinetics and efficacy for the combination of camizestrant and capivasertib. PATIENTS AND METHODS: SERENA-1 is a phase I, open-label, multi-part trial of camizestrant alone and in combination with other anticancer agents in women with ER-positive, HER2-negative advanced breast cancer. In parts I and J, participants received oral camizestrant 75 mg (once daily) in combination with oral capivasertib 400 mg (4 days on, 3 days off). RESULTS: Participants (n = 29) had a median of two previous lines of therapy in the advanced setting; 55.2% had received fulvestrant and 89.7% had received a cyclin-dependent kinase 4/6 inhibitor. Camizestrant in combination with capivasertib had a well-tolerated safety profile, with diarrhea (75.9%) and nausea (44.8%) being the most common adverse events. Median t(max) was achieved ∼4 hours and ∼2 hours post dose for camizestrant and capivasertib, respectively. Clinical benefit at 24 weeks was seen in 51.7% of participants, and median progression-free survival was 8.3 months. CONCLUSION: In these pretreated participants, camizestrant 75 mg in combination with capivasertib 400 mg was well tolerated, with a side effect profile consistent with each drug as monotherapy, and showed encouraging evidence of clinical efficacy.
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Date
2026
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Article
Citation
Vaklavas C, Oliveira M, Armstrong AC, Moreno I, Twelves C, Victoria Ruiz I, et al. Camizestrant in combination with capivasertib for women with ER-positive, HER2-negative advanced breast cancer: results from SERENA-1. ESMO Open. 2026 Jan 21;11(2):106049. Epub 2026/01/23.