Trial reportBreast (Edinburgh, Scotland)2026
Dose-dense adjuvant chemotherapy in HER2-low breast cancer: An exploratory analysis of the GIM2 trial.
Trial report in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00433420 (A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients), which is not on this map. Not yet cited in PubMed.
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A Phase III Randomized Study of EC Followed by Paclitaxel Versus FEC Followed by Paclitaxel, All Given Either Every 3 Weeks or 2 Weeks Supported by Pegfilgrastim, for Node Positive Breast Cancer Patients
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21 authors.
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Abstract
backgroundDose-dense (DD) adjuvant chemotherapy represents a standard treatment for patients with high-risk node-positive early-stage HER2-negative breast cancer (BC). In this exploratory analysis of the GIM2 trial, we investigated the efficacy of DD chemotherapy among patients with HER2-negative BC according to HER2 immunohistochemistry (IHC) score.
methodsPatients with node-positive early BC were randomized to receive either DD or standard schedule anthracycline- and taxane-based chemotherapy. HER2 status was assessed locally. Tumours with HER2 score 0 were classified as HER2-zero, those with a HER2 score 1+ or 2+ without ISH amplification as HER2-low. Tumours classified as HER2-negative with unknown IHC score were considered as a separate subgroup.
resultsOverall, 1243 subjects were eligible for this analysis, with 475 (38.2%) tumours classified as HER2-zero, 446 (35.9%) as HER2-low and 322 (25.9%) as HER2-negative with unknown IHC score. At a median follow-up of 14.9 years (IQR 8.4-16.2), no interaction was observed between treatment effect and HER2 status in invasive disease-free survival (iDFS) (p for interaction = 0.42) nor in overall survival (OS) (p for interaction = 0.34). Efficacy of DD chemotherapy was observed regardless of HER2 status: among patients with HER2-zero tumours, adjusted hazard ratio (aHR) for iDFS was 0.62 (95% confidence interval [CI] 0.45-0.85) and for OS was 0.55 (95% CI 0.36-0.84). Among patients with HER2-low tumours, aHR was 0.82 (95% CI 0.61-1.11) for iDFS and 0.84 (95% CI 0.57-1.23) for OS.
conclusionsIn patients with HER2-negative high-risk early BC, the benefit of DD chemotherapy was observed irrespective of HER2 status. (NCT00433420).
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