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Breast cancer is the most common malignancy in women. Clinical models such as Oncotype DX recurrence score (RS) and Clinical Treatment Score post–5 years (CTS5) model for survival prediction are crucial for clinical practice. However, it remains unclear whether CTS5 or RS would be a more powerful clinical model for recurrence risk evaluation. Therefore, we conducted the present study to compare the performance of CTS5 risk model and RS on different recurrence evaluation. And we further integrated the two models into a novel nomogram to improve the power for prognosis prediction. Female patients with invasive hormone receptor positive breast cancer in the Surveillance, Epidemiology, and End Results Program (SEER) database with RS data available were included. The clinicopathological data were directly extracted from SEER database. Participants were divided into three subsets according to recurrence timing (<36 months, between 36 and 60 months, and >60 months) for model evaluation. Survival receiver operating characteristic curve and C-index were calculated to evaluate discrimination. Calibration curve were used to visual inspection for calibration. Model comparison was assessed by net reclassification index (NRI) method. Nomogram prognostic model was developed with the combination of CTS5 score and RS and also included other critical clinicopathological parameters. In total, 64044 breast cancer patients were enrolled for analysis. The number of patients with survival <36 months (early recurrence subset), 36–60 months (intermediate recurrence subset) and >60 months (late recurrence subset) were 64044, 36878 and 15926, respectively. For model discrimination, CTS5 model was superior to RS for overall survival (OS) prediction (likelihood ratio test P < 0 0.001). RS model showed better performance for breast cancer specific survival (BCSS) in late recurrence subsets and worse performance in early and intermediate recurrence subsets than CTS5 (likelihood ratio test P < 0 0.001). For calibration, CTS5 model was superior to RS model for OS, which overestimated the recurrence risk in low-risk subgroup. Both models overestimated the risk for BCSS. In either early/intermediate/late recurrence patient subsets, there was no significant difference in NRI between two models in terms of both BCSS and OS, indicating the two models had comparable prognostic value. The nomogram which combined these two models largely improved the discrimination and calibration power (C-index 0.70–0.72). Our study proved the CTS5 risk model had comparable prognostic value as RS in HR + breast cancer patients. And the novel nomogram model had better discrimination and calibration than both CTS5 and RS, and future large-scale clinical trials are warranted for further validation. [ABSTRACT FROM AUTHOR]

Background: HER2 dual-blockade combined with aromatase inhibitors (AI) is a promising strategy to improve progression-free survival (PFS) in hormone receptor (HR) positive, metastatic breast cancer (MBC). Pyrotinib is a novel irreversible epidermal growth factor receptor/HER2 dual tyrosine kinase inhibitor. However, there is scarcity of data on the effectiveness and safety of pyrotinib combined with trastuzumab and AI as first-line treatment in a metastatic setting.Methods/design: The present study is a prospective, randomized, open-label trial. 198 patients with HER2+/HR+ MBC will be recruited. Eligible patients will be allocated (2:1) to either an experimental group (pyrotinib + trastuzumab + AI) or a control group (trastuzumab + AI). Allocation will be stratified by 1) time since adjuvant hormone therapy (≤ 12 months/> 12 months/no prior hormone therapy); 2) lesion sites (visceral / non-visceral). The primary endpoint is PFS.Discussion: To our knowledge, this is the first prospective randomized controlled trial to assess dual HER2-blockade with pyrotinib in the metastatic setting. This study will provide valuable evidence regarding the efficacy and safety of pyrotinib when combined with trastuzumab and an AI as first-line treatment for MBC. Moreover, it will also evaluate the feasibility of endocrine therapy as an alternative to chemotherapy in providing de-escalation therapy with less toxicity for advanced HR+/HER2+ patients.Trial Registration: ClinicalTrials.gov, ID: NCT03910712 . Registered on 10 Apr. 2019. [ABSTRACT FROM AUTHOR]

Background: HER2+ and hormone receptor (HoR)‐negative breast cancer usually associated with poor outcome. However, it remained elusive for the prognosis of small (T1a‐T1c) HER2+/HoR‐ breast cancer. The present study retrospectively analyzed the Surveillance, Epidemiology, and End Results (SEER) database to explore the clinicopathological characteristics and prognosis of T1a‐T1c HER2+/HoR‐ breast cancer. Material and Methods: Data for patients diagnosed with either HER2‐/HoR+or HER2+/HoR‐ T1a‐T1c breast cancer between 2010 and 2012 were obtained from SEER program. Survival analyses were conducted by Kaplan‐Meier method and Cox proportion hazard regression. Results: Totally, 2648 HER2+/HoR‐ and 56387 HER2‐/HoR+T1a‐T1c breast cancer patients were enrolled. There was a clear trend that tumor size had a positive correlation with advanced AJCC stage (P < 0.001) and N‐stage (P < 0.001). T1a and T1b HER2+/HoR‐ breast cancer had great homogeneity in that these two subgroups had comparable survival and both showed no significant survival difference with its counterpart of HER2‐/HoR+subtype. Conversely, T1c HER2+/HoR‐ breast cancers revealed worse prognosis than T1a/T1b HER2+/HoR‐ and T1c HER2‐/HoR+tumors (BCSS HR 3.847, P < 0.001; OS HR 2.055, P < 0.001). Conclusion: T1a and T1b HER2+/HoR‐ breast cancer had favorable prognosis and great homogeneity, indicating 1.0 cm may be a suitable cutoff for subclassification of T1 cancer. Future randomized clinical trials were warranted to verify this hypothesis and elucidate the biological behavior of small T1 tumor to facilitate precise medicine. The present study retrospectively analyzed the prognosis of T1a‐T1c HER2+/Hormone Receptor‐negative (HoR‐) breast cancer. T1a and T1b HER2+/HoR‐ breast cancer had great homogeneity in that these two subgroups had comparable survival and both showed no significant survival difference with its counterpart of HER2‐/HoR+subtype. Conversely, T1c HER2+/HoR‐ breast cancers revealed worse prognosis than T1a/T1b HER2+/HoR‐ and T1c HER2‐/HoR+tumors. Hence, compared to T1c, T1a and T1b HER2+/HoR‐ breast cancer had favorable prognosis and great homogeneity, indicating 1.0 cm may be a suitable cutoff for subclassification of T1 cancer. [ABSTRACT FROM AUTHOR]