Trial reportESMO open2025
Long-term effect of neoadjuvant denosumab treatment in high-risk early breast cancer (GeparX).
Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02682693 (Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design), which is not on this map. Cited by 1 paper.
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.
Investigating Denosumab as an add-on Neoadjuvant Treatment for RANK-positive or RANK-negative Primary Breast Cancer and Two Different Nab-Paclitaxel Schedules ; 2x2 Factorial Design (GeparX)
Who cites it
1 citing paper in PubMed.
- Right-sizing treatment for HER2-positive breast cancer: evolving algorithms across the disease continuum.Nature reviews. Clinical oncology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the GeparX trial (NCT02682693), neoadjuvant denosumab, in addition to either weekly or days 1 and 8 (d1,8) q22 nab-paclitaxel (nPac)-based chemotherapy, did not improve the pathological complete response (pCR) rate in early high-risk breast cancer patients, while the concomitantly applied weekly nPac regimen resulted in a significantly higher pCR rate compared with the interrupted regimen. PATIENTS AND
methodsGeparX is a randomized, open-label, phase II study comparing neoadjuvant treatment with or without denosumab and two different nPac schedules. Invasive disease-free survival (iDFS), distant disease-free survival (DDFS), overall survival (OS), and locoregional recurrence-free interval (LRRFI) were considered as time-to-event endpoints.
resultsAfter a median follow-up of 62.3 months, there was no statistically significant difference in iDFS [hazard ratio (HR) 0.86, 95% confidence interval (CI) 0.62-1.21, P = 0.39], DDFS (HR 0.77, 95% CI 0.54-1.11, P = 0.16), LRRFI (HR 1.41, 95% CI 0.76-2.63, P = 0.28), and OS (HR 0.81, 95% CI 0.50-1.33, P = 0.41) between denosumab-treated and non-denosumab-treated patients. However, numerically fewer distant relapses occurred in patients with denosumab treatment (9.2% versus 13.8%). Denosumab treatment resulted in a significant risk reduction of 36% for distant relapse in the multivariate analysis (DDFS; HR 0.64, 95% CI 0.43-0.93, P = 0.02). There was no overall differential impact of the two neoadjuvant chemotherapy (NACT) regimens (nPac weekly or nPac d1,8 q22) on long-term outcome in the total study population. Triple-negative breast cancer (TNBC) patients without a pCR (non-pCR) had a significantly worse iDFS (HR 0.22, 95% CI 0.12-0.39, P < 0.0001), with a trend toward improved iDFS in those receiving weekly nPac at the 5-year landmark (iDFS rate at 60 months: 58.4% versus 72%).
conclusionsDenosumab as part of neoadjuvant therapy, although not improving the pCR rate, significantly reduced the risk of distant relapses. Other long-term outcome parameters did not differ between the treatment arms. TNBC patients, especially when not achieving pCR, seem to benefit from weekly nPac.
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