Two neoadjuvant nab-paclitaxel regimes with or without denosumab for primary breast cancer

Adjuvant denosumab might improve disease-free survival in HR-positive primary breast cancer, but there are no data on the use of denosumab in the neoadjuvant setting. The optimal neoadjuvant nab-paclitaxel schedule for primary breast cancer in terms of efficacy and safety is unclear. The phase 2b, 2 x 2 randomized GEPARX clinical trial at 38 centers in Germany found that addition of denosumab to anthracycline/taxane-based neoadjuvant chemotherapy did not improve pCR rates. Neoadjuvant nab-paclitaxel at a dosage of 125 mg/m² weekly significantly improved the pCR rate compared with a days 1 and 8 every three weeks schedule, overall and in TNBC, but generated higher toxicity.