Trial reportESMO open2026
Phase II study of trastuzumab-pkrb plus gedatolisib in patients with HER2-positive metastatic breast cancer who progressed after two or more HER2-directed therapies.
Trial report in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
30 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo evaluate the activity and safety of trastuzumab-pkrb plus gedatolisib in patients with treatment-refractory human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) harboring phosphatidylinositol 3-kinase (PI3K) pathway alterations. PATIENTS AND
methodsIn this multicenter, single-arm phase II study, eligible patients had HER2-positive MBC with PI3K pathway aberrations identified by tumor or circulating cell-free DNA and had progressed after at least two prior HER2-directed therapies. Patients received trastuzumab-pkrb (8 mg/kg loading dose, then 6 mg/kg IV every 3 weeks) plus gedatolisib (180 mg IV on days 1, 8 and 15 of each 21-day cycle). The primary endpoint was objective response rate (ORR), 90% power with one-sided 5% type I error, assuming a 25% target for the combination therapy. The trial closed early after 44 patients due to changes in regulatory sponsorship.
resultsPI3K pathway alterations included PIK3CA kinase domain mutations (59%), helical domain mutations (25%), and PTEN deletions (5%). The ORR was 43.2% [95% confidence interval (CI) 28.3%-59.0%], with two complete and 17 partial responses. Disease control rate was 86.4%. Median progression-free survival (PFS) was 6.01 months (95% CI 5.03-7.69), and median overall survival (OS) was 24.74 months (95% CI 17.28-NA) after 32.05 months of follow-up. Oral mucositis (90.9%; 15.9% grade ≥3) and hyperglycemia (25.0%; 2.3% grade 3) were most frequent, and no treatment-related deaths occurred. Early circulating tumor DNA dynamics predicted PFS and OS.
conclusionTrastuzumab-pkrb plus gedatolisib demonstrated a 43.2% response rate and manageable toxicity, supporting dual HER2/PI3K pathway targeting in heavily pretreated HER2-positive MBC.
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