Current therapies for HER2-positive breast cancer have limited efficacy in patients with triple-positive breast cancer (TPBC). We conduct a multi-center single-arm phase 2 trial to test the efficacy and safety of an oral neoadjuvant therapy with pyrotinib, letrozole and dalpiciclib (a CDK4/6 inhibitor) in patients with treatment-naïve, stage II–III TPBC with a Karnofsky score of ≥70 (NCT04486911). The primary endpoint is the proportion of patients with pathological complete response (pCR) in the breast and axilla. The secondary endpoints include residual cancer burden (RCB)−0 or RCB-I, objective response rate (ORR), breast pCR (bpCR), safety and changes in molecular targets (Ki67) from baseline to surgery. Following 5 cycles of 4-week treatment, the results meet the primary endpoint with a pCR rate of 30.4% (24 of 79; 95% confidence interval (CI), 21.3–41.3). RCB-0/I is 55.7% (95% CI, 44.7–66.1). ORR is 87.4%, (95% CI, 78.1–93.2) and bpCR is 35.4% (95% CI, 25.8–46.5). The mean Ki67 expression reduces from 40.4% at baseline to 17.9% (P < 0.001) at time of surgery. The most frequent grade 3 or 4 adverse events are neutropenia, leukopenia, and diarrhoea. There is no serious adverse event- or treatment-related death. This fully oral, chemotherapy-free, triplet combined therapy has the potential to be an alternative neoadjuvant regimen for patients with TPBC.
Background Breast mucinous adenocarcinoma is a group of malignant tumors of epithelial origin of the breast with a good prognosis; however, whether its treatment regimen should be consistent with that of non-specific types of breast cancer remains to be investigated. Methods In this study, the clinicopathological information, treatment modalities, and prognosis of 10,466 patients with mucinous adenocarcinoma of the breast from the Surveillance, Epidemiology, and End Results (SEER) database were analyzed. Results After adjusting for other factors, radiotherapy showed a favorable benefit in most subgroups; although this may be associated with a higher proportion of breast-conserving surgery in early cases, chemotherapy did not show any benefit. In particular, estrogen receptor-negative subgroup patients who received chemotherapy had a poorer prognosis. Conclusions Although derived from retrospective studies, the results of these analyses revealed trends that may warrant further study.
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