Trial reportBreast cancer research : BCR2026
Pathway activity profiling can predict neoadjuvant endocrine therapy response in HR+ HER2- postmenopausal early stage breast cancer.
Trial report in Breast cancer research : BCR, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03283384 (Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo improve patient selection for neoadjuvant endocrine therapy (NET), signal transduction pathway profiles of estrogen receptor (ER)-, androgen receptor (AR), were studied and compared to standard immunohistochemistry (IHC) in postmenopausal patients with HR+ (IHC ER ≥ 50%, progesterone receptor any), HER2- breast cancer of the NEOLBC trial (NCT03283384).
methodsAfter two weeks of NET with letrozole, patients with Ki67 (Ki67-2 W) ≥ 1% IHC were randomized to receive letrozole + ribociclib or standard chemotherapy until surgery, while patients with Ki67-2 W < 1% continued NET (letrozole monotherapy). Baseline, two week- and resection FFPE samples of 82 patients were analyzed using mRNA-based OncoSIGNal profiling test, providing the pathway activity score (PAS).
resultsDespite samples being ER-IHC ≥ 50%, the ER-PAS varied over a range of 32–78 (scale from 0 to 100) with 20% of the patients showing low ER-PAS (32–45; similar to triple negative breast cancer tissue). At 2 weeks, 89% (73/82) of the patients showed a decreased ER-PAS (11.6 ± 8.6) compared to baseline (p < 0.001), whereas ER-IHC remained unchanged. Patients with complete response (RECIST1.1) appeared to have a higher ER-PAS at baseline compared to those with stable disease (p = 0.03), ROC analysis confirmed ER-PAS at baseline as an acceptable predictive factor for MRI response (AUC ≥ 0.7). Lastly, baseline and 2-week pathway activity profiling could identify targetable escape mechanisms for NET non-responders, which could improve personalized treatment strategies.
conclusionER IHC+ does not correlate to ER-PAS and ER-PAS is a more dynamic marker that appears to reflect variable NET response more accurately than IHC.
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