We are pleased to inform you that primary results from GeparX trial have been published in JAMA Oncology.
The GeparX (NCT02682693) was a multicenter, prospective, open-label, phase 2b, 2 × 2 randomized clinical trial conducted by GBG and AGO-B at 38 German sites between February 2017 and March 2019. Eligible patients had unilateral or bilateral primary breast cancer, stage cT2-cT4a-d or cT1c, with either clinically node-positive or pathologically node-positive or HR-negative disease, or Ki-67 proliferation index greater than 20%, or HER2-positive breast cancer. Primary objective was to determine whether adding denosumab to anthracycline/taxane-containing neoadjuvant chemotherapy increases the pathological complete response (pCR) rate and which nab-paclitaxel schedule is more effective in this neoadjuvant setting.
Conclusion: In the GeparX trial, denosumab added to anthracycline/taxane-based neoadjuvant chemotherapy did not improve pCR rates. Nab-paclitaxel at a dosage of 125 mg/m2 weekly significantly increased the pCR rate compared with the days 1 and 8, every-3-weeks schedule overall and in TNBC, but generated higher toxicity.
Blohmer JU, Link T, Reinisch M, et al. Effect of Denosumab Added to 2 Different nab-Paclitaxel Regimens as Neoadjuvant Therapy in Patients With Primary Breast Cancer: The GeparX 2 × 2 Randomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1010-1018. doi: 10.1001/jamaoncol.2022.1059.