Background: The introduction of multigene assays has significantly altered the indications for adjuvant chemotherapy in hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer. The 70-gene signature (MammaPrintTM) test has demonstrated its ability to identify prognostic capability. Patients with high clinical risk classified as low risk by MammaPrintTM (MP) can be safely spared adjuvant chemotherapy. However, it is worth noting that the majority of clinical studies conducted on MP have predominantly involved Caucasian populations. Breast cancer is known to exhibit biological and clinical differences across different ethnicities and races. In China, the onset of breast cancer occurs a decade earlier than in Western populations, with an average age of diagnosis at 48.7 years and a peak incidence between 45 to 49 years. The prevalence of breast cancer among patients under 50 is significantly higher than in Western countries. Consequently, it is crucial to validate the performance of MP across diverse populations to ensure its generalizability and reliability. This study aimed to explore the real-world utilization of MP among Chinese patients. Method: From March 2018 to June 2022, genomic analysis utilizing the 70-gene platform, MammaPrintTM, was conducted on a consecutive series of 637 patients. An evaluation was performed to assess the distribution of clinicopathological characteristics across various risk groups as determined by the MP assay. This assessment was further compared with the findings from the pivotal MINDACT trial to indentify any notable differences. A robust analysis was conducted using the Kaplan-Meier method for survival curves and the Cox proportional hazards model to estimate hazard ratios. Results: Among the 637 patients enrolled in the study, 261 (41.0%) were identified as high risk, with a substantial majority, 214 (82.0%), undergoing chemotherapy. In contrast, 376 (59.0%) were categorized as low risk, with a significantly smaller proportion, 46 (12.2%), receiving chemotherapy. A stark contrast was observed in the distribution of risk categories between the two groups, with a statistical significance (p < 0.001). Patients characterized by tumor grade 1, Ki67<30%, and PR ≥ 20% were predominantly classified as low risk. Compared to the MINDACT study population, the patients in this cohort were notably younger, with 33.3% versus 56.2% being under 50 years of age, and had larger tumors with higher tumor grades (p < 0.001). Notably, younger patients, those with Ki67≥ 30%, and lymph node-positive patients were more inclined to receive chemotherapy, even when classified as low risk. Conversely, older patients in the high-risk group were less likely to be treated with chemotherapy. During a median follow-up period of 33 months (8 -66 months), 17 events were recorded. No significant difference in breast cancer free interval (BCFI) was observed between genetically high and low-risk groups for all patients (96.5% vs 97.3%, P=0.28), including those under 50 years of age (95.5% vs 97.5%, P=0.863). However, among patients aged 50 or older, those classified as genetically low risk exhibited a superior BCFI compared to their high-risk counterparts (98.9% vs. 97.1%, P=0.047). It was interesting to observe that the BCFI significantly improved following ovarian function suppression in patients under 50 years of age identified as low risk, compared to those without such suppression (P=0.035). Nonetheless, no significant difference was noted between the two groups for high-risk patients (P=0.115). Conclusion: The real-world data clearly illustrate the benefits of the MP assay in decreasing the necessity for adjuvant chemotherapy in Chinese patients with low genomic risk in HR+/HER2- early breast cancer. The recurrence rates were similar in the high and low risk groups, which might be due to the favorable prognosis of the study population, the effectiveness of tailored treatments in managing breast cancer across different risk profiles and the short follow-up period. The poorer prognosis observed in high-risk patients aged 50 or older might be attributed to the fact that a significant number older patients did not receive chemotherapy. Our data showed that low-risk patients under the age of 50 could benefit from ovarian function suppression. This finding warrants further investigation. Citation Format: Weijuan Jia, Yongwen Jiang, Anqin Zhang, Fengxia Gan, Qian Ouyang. Early-stage HR+/HER2- breast cancer patients under 50 years old with a low-risk identified by the 70-gene signature (MammaPrintTM) could benefit from ovarian function suppression: A real-world study in China [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P1-11-12.

e12507 Background: Neratinib, a pan-HER tyrosine kinase inhibitor, was approved in China in 2020 based on the results of the ExteNET trial. With the increasing use of neoadjuvant treatment and recent approval of additional adjuvant anti-HER2 therapies, the current treatment landscape for HER2+ EBC in China has recently evolved. A real-world study investigating neratinib use in a Chinese population will provide valuable insights into the evolving landscape of HER2+ EBC and offer a better understanding of neratinib's effectiveness and safety in patients who have received different prior treatments. Methods: This is a multi-center, prospective, non-interventional study enrolled 500 patients with HER2+ EBC scheduled to receive extended adjuvant neratinib treatment. (NCT05491057) The primary and secondary objectives are to describe real-world adjuvant treatment patterns and to observe the safety of neratinib, respectively. This interim analysis will report the patient characteristics and prior treatments before receiving extended adjuvant neratinib. Results: As of 28 October 2024, 500 patients were included in the analysis. The median age of patients was 50.5 years. A total of 328 patients (65.6%) were postmenopausal. At primary diagnosis, a total of 275 patients (55.0%) had HER2+/hormone receptor positive (HR+) tumors; 286 patients (57.2%) had stage I-II tumors, and 183 patients (36.6%) had stage III tumors. A total of 166 patients (33.2%) received neoadjuvant therapy. Ninety-six of them (57.8%) did not achieve pCR. Trastuzumab plus pertuzumab was the most used neoadjuvant (n=152, 91.6%) and adjuvant (451, 90.2%) treatment. The median time from completion of previous adjuvant therapy until the start of neratinib treatment was 1.14 months (interquartile range: 0.69 - 2.43). The initial dose of neratinib was <240 mg for 67% and 240 mg for 33% of the patients. Two hundred ninety-seven patients (59.4%) adopted anti-diarrheal strategies at least once, including drug prophylaxis (loperamide or other agents (90, 18%), dose escalation (140, 28%), or both (67, 13.4%). Conclusions: The profile of patients and pattern of anti-HER2 treatment prior to extended adjuvant neratinib reflected the current treatment landscape for HER2+ EBC in China. With increasing clinical experience, more than half of patients using neratinib in the real-world setting are now receiving diarrhea prophylaxis. Clinical trial information: NCT05491057 . Adjuvant regimen Total N=500 Patients with neoadjuvant treatment, n (33.2%) Patients without neoadjuvant treatment, n N=334 (66.8%) Totaln=166 pCRn=59 (35.5%) non-pCRn=96 (57.8%) Trastuzumab 38 (7.6) 3 (1.8) 0 3 (3.1) 35 (10.5) Trastuzumab+Pertuzumab 451 (90.2) 153 (92.2) 59 (100) 85 (88.5) 298 (89.2) T-DM1 9 (1.8) 9 (5.4) 0 8(8.3) 0 Other anti-HER2 therapy 2 (0.4) 1 (0.6) 0 0 1(0.3)

BACKGROUND:Pegylated liposomal doxorubicin (PLD) was shown to have comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity. This study evaluated the cardiotoxicity and efficacy of the PLD-based regimen compared with those of the doxorubicin-based regimen as adjuvant therapy for early-stage breast cancer (BC). METHODS:In this open-label, randomized controlled trial, patients with early-stage BC were assigned to receive either 4 cycles of PLD (study group) or doxorubicin (control group) plus cyclophosphamide followed by 4 cycles of docetaxel/paclitaxel. The primary endpoint was cardiotoxicity. RESULTS:Between November 2017 and September 2019, 247 patients (study group, n = 131; control group, n = 116) were enrolled. Incidence rates of abnormal left ventricular ejection fraction (LVEF, 0 vs. 1.7%) and congestive heart failure (0.0% vs. 0.9%) were similar between the two groups (all P > 0.05). A lower proportion of elevated high-sensitivity cardiac troponin T (3.8% vs. 30.2%, P < 0.001) was observed in the study group. The 5-year disease-free survival (82.7% vs. 83.8%) and overall survival (90.4% vs. 91.6%) rates were comparable (all P > 0.05). Grade 3-4 adverse events in the study group were significantly less than in the control group (43.5% vs. 61.2%, P = 0.005). CONCLUSION:The PLD-based regimen for early-stage BC showed significantly lower rates of elevated hs-cTnT and grade 3-4 AEs with comparable efficacy to the doxorubicin-based regimen. (ClinicalTrials.gov Identifier: NCT03949634; IRB Approved: Ethics committee institutional review board of Shanghai Cancer Hospital, Fudan University's (No. 1706173-19-1904B) and other center).

PURPOSE:To evaluate the efficacy and safety of adjuvant epirubicin plus cyclophosphamide followed by taxanes (EC-T) versus EC-T plus carboplatin (EC-TCb) in patients with early-stage triple-negative breast cancer (TNBC). PATIENTS AND METHODS:In this phase III trial, patients with TNBC with node-positive or node-negative (tumor size ≥1.0 cm) disease who received definitive surgery, were stratified by lymph node status and randomly assigned in a 1:1 ratio to receive four cycles of EC followed by four cycles T with or without carboplatin adjuvant chemotherapy. The primary end point was disease-free survival (DFS). Secondary end points included distant DFS (DDFS), overall survival (OS), and safety. This study had 80% power to detect a DFS hazard ratio (HR) of 0.64, with a two-sided type I error of 0.05. RESULTS:A total of 786 patients were randomly assigned to receive EC-T (n = 391) or EC-TCb (n = 395) between March 2016 and March 2023. With a median follow-up of 4.52 (IQR, 2.83-6.06) years, 62 and 41 events were reported in the EC-T and EC-TCb arm, respectively. Adding carboplatin significantly improved DFS (HR, 0.66; [95% CI, 0.44 to 0.97]; P = .034), DDFS (HR, 0.61 [95% CI, 0.38 to 0.98]; P = .040), and OS (HR, 0.39 [95% CI, 0.16 to 0.94]; P = .029). Grade 3 to 4 adverse events were more frequent among the EC-TCb arm (49.9%) than the EC-T arm (38.7%), primarily driven by higher incidence of neutropenia (47.0% v 37.8%) and thrombocytopenia (4.5% v 0%). Other grade 3 to 4 toxicities were comparable. CONCLUSION:Adding carboplatin to adjuvant EC-T chemotherapy significantly improves DFS, DDFS, and OS in patients with early-stage TNBC. Although increased hematologic toxicity was observed, no new safety signals emerged.

BackgroundThis study investigated the clinical value of breast magnetic resonance imaging (MRI) radiomics for predicting axillary lymph node metastasis (ALNM) and to compare the discriminative abilities of different combinations of MRI sequences.MethodsThis study included 141 patients diagnosed with invasive breast cancer from two centers (center 1: n = 101, center 2: n = 40). Patients from center 1 were randomly divided into training set and test set 1. Patients from center 2 were assigned to the test set 2. All participants underwent preoperative MRI, and four distinct MRI sequences were obtained. The volume of interest (VOI) of the breast tumor was delineated on the dynamic contrast-enhanced (DCE) postcontrast phase 2 sequence, and the VOIs of other sequences were adjusted when required. Subsequently, radiomics features were extracted from the VOIs using an open-source package. Both single- and multisequence radiomics models were constructed using the logistic regression method in the training set. The area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, and precision of the radiomics model for the test set 1 and test set 2 were calculated. Finally, the diagnostic performance of each model was compared with the diagnostic level of junior and senior radiologists.ResultsThe single-sequence ALNM classifier derived from DCE postcontrast phase 1 had the best performance for both test set 1 (AUC = 0.891) and test set 2 (AUC = 0.619). The best-performing multisequence ALNM classifiers for both test set 1 (AUC = 0.910) and test set 2 (AUC = 0.717) were generated from DCE postcontrast phase 1, T2-weighted imaging, and diffusion-weighted imaging single-sequence ALNM classifiers. Both had a higher diagnostic level than the junior and senior radiologists.ConclusionsThe combination of DCE postcontrast phase 1, T2-weighted imaging, and diffusion-weighted imaging radiomics features had the best performance in predicting ALNM from breast cancer. Our study presents a well-performing and noninvasive tool for ALNM prediction in patients with breast cancer.

Purpose:Results from studies of extended capecitabine after the standard adjuvant chemotherapy in early stage triple-negative breast cancer (TNBC) were inconsistent, and only low-dose capecitabine from the SYSUCC-001 trial improved disease-free survival (DFS). Adjustment of the conventional adjuvant chemotherapy doses affect the prognosis and may affect the efficacy of subsequent treatments. This study investigated whether the survival benefit of the SYSUCC-001 trial was affected by dose adjustment of the standard adjuvant chemotherapy or not.Patients and Methods:We reviewed the adjuvant chemotherapy regimens before the extended capecitabine in the SYSUCC-001 trial. Patients were classified into "consistent" (standard acceptable dose) and "inconsistent" (doses lower than acceptable dose) dose based on the minimum acceptable dose range in the landmark clinical trials. Cox proportional hazards model was used to investigate the impact of dose on the survival outcomes.Results:All 434 patients in SYSUCC-001 trial were enrolled in this study. Most of patients administered the anthracycline-taxane regimen accounted for 88.94%. Among patients in the "inconsistent" dose, 60.8% and 47% received lower doses of anthracycline and taxane separately. In the observation group, the "inconsistent" dose of anthracycline and taxane did not affect DFS compared with the "consistent" dose. Moreover, in the capecitabine group, the "inconsistent" anthracycline dose did not affect DFS compared with the "consistent" dose. However, patients with "consistent" taxane doses benefited significantly from extended capecitabine (P=0.014). The sufficient dose of adjuvant taxane had a positive effect of extended capecitabine (hazard ratio [HR] 2.04; 95% confidence interval [CI] 1.02 to 4.06).Conclusion:This study found the dose reduction of adjuvant taxane might negatively impact the efficacy of capecitabine. Therefore, the reduction of anthracycline dose over paclitaxel should be given priority during conventional adjuvant chemotherapy, if patients need dose reduction and plan for extended capecitabine.

The 2021 National Comprehensive Cancer Network guidelines recommend that adjuvant chemotherapy combined with trastuzumab be considered for human epidermal growth factor receptor 2 (HER-2)-positive breast cancer patients with small tumors (tumor diameter ≤1 cm) and negative lymph nodes. Additionally, the prognostic factors and clinical significance of HER-2-positive breast cancer with negative lymph nodes and a tumor diameter ≤1 cm remain unclear. In the present study, the clinical data and prognostic factors of 87 patients with HER-2-positive breast cancer with negative lymph nodes and a tumor diameter ≤1 cm admitted to Guangdong Women and Children Hospital from January 2013 to December 2019 were retrospectively analyzed. The median follow-up time was 70 months, the disease-free survival (DFS) of all patients was 94.3% and the overall survival (OS) was 100%. Univariate analysis of prognosis demonstrated that patients aged ≤40 years had significantly lower DFS than those aged >40 (80.8 vs. 100.0%, P<0.001). DFS was significantly improved in patients who were hormone-receptor-positive and patients who received endocrine therapy compared with patients who were estrogen receptor negative and patients who did not receive endocrine therapy (100.0 vs. 89.6%, P=0.039; 100.0 vs. 90.0%, P=0.049). Prognostic univariate analysis demonstrated that patient age, hormone receptor status and use of endocrine therapy were significantly related to the DFS (P<0.05), while none of these were independent factors related to the DFS in the prognostic multivariate analysis (P=0.240, P=0.976 and P=0.925). The proportion of patients with a tumor diameter 0.5-1 cm receiving adjuvant anti-HER-2 treatment was significantly greater compared with patients with tumors with a diameter ≤0.5 cm (46.4 vs. 18.6%, P<0.05). There was no significance difference in the DFS of patients treated with adjuvant chemotherapy with or without anti-HER-2 therapy with tumor diameters ≤0.5 cm (P>0.05), but there was a significant difference in the DFS of patients with a tumor diameter 0.5-1 cm (P<0.05). These results suggested that adjuvant chemotherapy, with or without anti-HER-2 therapy, may affect the prognosis of HER-2-positive breast cancer patients with negative lymph nodes and a tumor diameter of 0.5-1 cm. Therefore, it could be recommended that such patients receive adjuvant chemotherapy and anti-HER-2 therapy in the future.

Abstract Aims: The addition of extended capecitabine after standard neo/adjuvant chemotherapy shows controversial results in triple-negative breast cancer (TNBC) patients between SYSUCC-001 trial and CIBOMA trial. Patients presents different responses to diverse regimens, and different dose strengths also affect their prognosis. Hence, we tried to investigate whether the benefit from SYSUCC-001 is effected by the strength of previous adjuvant chemotherapy. Methods: We reviewed the neo/adjuvant chemotherapy regimens, dose divide by body surface area, etc. of TNBC patients in SYSUCC-001 trial. Their therapeutic dose were classified into consistent and inconsistent with CIBOMA trial. Besides, we stratified patients into the strong regimen arm (A/EC-T and TA/EC) and medium regimen arm (A/EC, TA/E, CMF, FA/EC, FA/EC-T, and TC) according to their specific neo/adjuvant treatment.Subsequently, we compared differences in baseline characteristics between the strong and medium regimen arms, and further investigated the impact of therapeutic regimens and dose on the survival outcome of TNBC patients in SYSUCC-001 trial(the median follow-up is 61months, interquartile range, 44-82months). Results: A total of 434 TNBC patients were included in this study. Among them, patients who used strong chemotherapy regimen accounted for about 76.74%, and those who used medium regimen accounted for 23.26%. About 32.3% and 52.2% patients received the standard doses of anthracyclines and taxanes separately according to minimum acceptable regimens for chemotherapy in CIBOMA trial. In our analysis we found the dose strength did not affect the DFS in the observe group. However, the standard dose of taxanes improved the DFS in capecitabine group [HR, 2.04 (1.02 - 4.06)]. The interaction analysis showed that the strength of treatment regimenand anthracycline dose did not affect DFS. Whereas, subgroup analysis showed TNBC patients with standard dose of taxanes significantly benefited from capecitabine (P = 0.014). In addition, the standard dose of taxanes could improve DFS. Conclusions: The strength of neo/adjuvant chemotherapy does not affect the curative effect of capecitabine maintenance chemotherapy. The benefits of the SYSUCC-001 study are mainly from one-year capecitabine administration. Moreover, the standard dose of chemotherapy especially taxanes is a positive factor for the effect of capecitabine treatment. So in some special condition, such as patients can’t endure the side effect of the chemotherapy, we’d better reduce the dose of anthracycline not the taxanes.

目的 探讨超声光散射乳腺诊断系统(简称乳光超)在多中心乳腺癌筛查中对乳房影像报告及数据系统(BI-RADS)3、4级乳腺结节的诊断价值.方法 纳入2017-10-01-2018-05-316家妇幼保健院(广东省妇幼保健院、北京市海淀妇幼保健院、广州市妇女儿童医疗中心、安阳市妇幼保健院、长沙市妇幼保健院、北京市延庆妇幼保健院)36706名女性体检筛查及门诊筛查者,均进行乳光超和超声2种检查,部分进行乳腺X射线检查,均进行BI-RADS分级.任意一种检查方法BI-RADS 4级者进行活检(空芯针、真空辅助微创旋切或手术活检),BI-RADS 3级者至少随机选取20％进行活检.分析乳光超和超声筛查乳腺癌的灵敏度和特异度,探讨2种检查方法区分BI-RADS 3和4级肿块及≤1 cm肿块的能力.采用SPSS 22.0对数据进行统计学分析,构成比比较采用χ2检验.结果 6家研究单位共采集36706名患者数据,有肿块病例为6237例,肿块检出率为16.99％,活检病例为1056例,活检率为2.88％.乳光超灵敏度大于超声(0.932 vs 0.915),差异无统计学意义,P=0.942.乳光超特异度大于超声(0.809 vs 0.737),差异有统计学意义,P<0.001.乳光超与超声检查的BI-RADS 3级恶性率分别为3.39％和6.78％,差异无统计学意义,P=0.316;乳光超与超声BI-RADS 4级良性率分别为17.25％和25.38％,差异有统计学意义,P<0.001.结论 乳光超在乳腺筛查中对BI-RADS 3、4级结节的诊断准确性优于超声,可作为早期乳腺癌筛查的有效方法之一.

肉芽肿性乳腺炎(granulomatous mastitis,GLM)是非哺乳期乳腺炎之一,好发于有哺乳史的经产女性,是一种良性的肉芽肿性病变.近年来,该病的发病率逐渐升高,临床上越来越常见.因该病病程漫长,病情容易反复、经久不愈,给患者的身心造成了较大的伤害.糖皮质激素是治疗GLM最常用的药物之一,但目前临床上没有统一的用药标准,使用剂量及疗程各有所异.因激素的用法、用量错误,在治疗过程中不仅延误了患者的病情,还引起了诸多的副作用.本文作者大量地阅读了近年来国内外关于激素治疗GLM的相关文献,详细阐述了激素治疗GLM的最新进展,以供临床参考.

Importance Among all subtypes of breast cancer, triple-negative breast cancer has a relatively high relapse rate and poor outcome after standard treatment. Effective strategies to reduce the risk of relapse and death are needed. Objective To evaluate the efficacy and adverse effects of low-dose capecitabine maintenance after standard adjuvant chemotherapy in early-stage triple-negative breast cancer. Design, Setting, and Participants Randomized clinical trial conducted at 13 academic centers and clinical sites in China from April 2010 to December 2016 and final date of follow-up was April 30, 2020. Patients (n = 443) had early-stage triple-negative breast cancer and had completed standard adjuvant chemotherapy. Interventions Eligible patients were randomized 1:1 to receive capecitabine (n = 222) at a dose of 650 mg/m2 twice a day by mouth for 1 year without interruption or to observation (n = 221) after completion of standard adjuvant chemotherapy. Main Outcomes and Measures The primary end point was disease-free survival. Secondary end points included distant disease-free survival, overall survival, locoregional recurrence-free survival, and adverse events. Results Among 443 women who were randomized, 434 were included in the full analysis set (mean [SD] age, 46 [9.9] years; T1/T2 stage, 93.1%; node-negative, 61.8%) (98.0% completed the trial). After a median follow-up of 61 months (interquartile range, 44-82), 94 events were observed, including 38 events (37 recurrences and 32 deaths) in the capecitabine group and 56 events (56 recurrences and 40 deaths) in the observation group. The estimated 5-year disease-free survival was 82.8% in the capecitabine group and 73.0% in the observation group (hazard ratio [HR] for risk of recurrence or death, 0.64 [95% CI, 0.42-0.95]; P = .03). In the capecitabine group vs the observation group, the estimated 5-year distant disease-free survival was 85.8% vs 75.8% (HR for risk of distant metastasis or death, 0.60 [95% CI, 0.38-0.92]; P = .02), the estimated 5-year overall survival was 85.5% vs 81.3% (HR for risk of death, 0.75 [95% CI, 0.47-1.19]; P = .22), and the estimated 5-year locoregional recurrence-free survival was 85.0% vs 80.8% (HR for risk of locoregional recurrence or death, 0.72 [95% CI, 0.46-1.13]; P = .15). The most common capecitabine-related adverse event was hand-foot syndrome (45.2%), with 7.7% of patients experiencing a grade 3 event. Conclusions and Relevance Among women with early-stage triple-negative breast cancer who received standard adjuvant treatment, low-dose capecitabine maintenance therapy for 1 year, compared with observation, resulted in significantly improved 5-year disease-free survival. Trial Registration ClinicalTrials.gov Identifier: NCT01112826.

first-line therapy patients HR+HER2+ therapy Abstract 70 Purpose: There is no research evidence demonstrate which is the better partner 71 strategy, endocrine therapy or chemotherapy, to combine with anti-HER2 therapy as 72 the first line management of hormone receptor (HR)-positive and HER2- positive 73 metastatic breast cancer (MBC). We wished to ascertain if trastuzumab plus endocrine 74 therapy is non-inferior to trastuzumab plus chemotherapy. 75 Experimental Design: We conducted an open-label, non-inferiority, phase-3, 76 randomized, controlled trial (NCT01950182) at nine hospitals in China. Participants, 77 stratified by previous adjuvant endocrine therapy and disease status (recurrent disease 78 vs. de novo metastasis), were assigned randomly (1:1) to receive trastuzumab plus 79 endocrine therapy (per investigator's choice of oestrogen-receptor modulators or 80 aromatase inhibitor, with/without concurrent ovarian suppression) or chemotherapy 81 (per investigator's choice of taxanes, capecitabine, or vinorelbine). The primary 82 endpoint was progression-free survival (PFS) with a non-inferiority upper margin of 83 1.35 for the hazard ratio. The intention-to-treat population was used in primary and 84 safety analyses. Results: A total of 392 patients were enrolled and assigned randomly to receive trastuzumab plus endocrine therapy (ET group, n=196) or trastuzumab plus 87 chemotherapy (CT group, n=196). After a median follow-up of 30.2 months (IQR 88 15.0–44.7), the median PFS was 19.2 months (95%CI 16.7–21.7) in the ET group and 89 14.8 months (12.8–16.8) in the CT group (hazard ratio 0.88, 95%CI 0.71–1.09; p non-inferiority <0.0001). A significantly higher prevalence of toxicity was observed in

e12511 Background: The role of secondary prophylaxis with pegfilgrastim (brand name: Jinyouli) in Chinese breast cancer patients has not been fully evaluated. We assessed the efficacy and safety of pegfilgrastim in secondary prophylaxis of chemotherapy-induced neutropenia in breast cancer patients. Methods: In the open-label, single-arm, multicenter trail, 319 patients were enrolled. Breast cancer patients who developed grades 3/4 neutropenia in the previous chemotherapy cycle were given a fixed dose of subcutaneous pegfilgrastim, 24-48 hours after receiving the same chemotherapy regimen in the subsequent cycle. A dose of 6mg/cycle was given to patients weighed ≥45kg, and a dose of 3mg/cycle was given to patients weighed <45kg. The primary end point was the incidence of grade 3/4 neutropenia and secondary end point was the incidence of febrile neutropenia (FN). Results: In patients who received prophylactic pegfilgrastim, the incidence of grade 3/4 neutropenia was reduced to 12.53% (95% CI, 9.1 to 16.7) and the incidence of FN was reduced from 6.58% (95% CI, 4.1 to 9.9) in the screening cycle to 0.94% (95% CI, 0.2 to 2.7)(Table). Among the 40 patients who still developed grades 3/4 neutropenia after receiving pegfilgrastim, the absolute neutrophil count (ANC) was not significantly different between patients with (n=10) or without (n=30) additional filgrastim treatment. The most common adverse events (AEs) associated with pegfilgrastim were bone pain and myalgia, which were prevalent in 10% to 15% of the patients. However, both AEs were mild or moderate (grades 1/2). Conclusions: Prophylactic administration of pegfilgrastim is effective and safe in reducing the risk of grades 3/4 neutropenia and FN in breast cancer patients after receiving chemotherapy. [Table: see text]

Background Taxane-induced peripheral neuropathy (TIPN) is a dose-limiting adverse effect. Ganglioside-monosialic acid (GM1) functions as a neuroprotective factor. We assessed the effects of GM1 on the prevention of TIPN in breast cancer patients. Methods We conducted a randomized, double-blind, placebo-controlled trial including 206 patients with early-stage breast cancer planning to receive taxane-based adjuvant chemotherapy with a follow-up of more than 1year. Subjects were randomly assigned to receive GM1 (80mg, day -1 to day 2) or placebo. The primary endpoint was the Functional Assessment of Cancer Treatment Neurotoxicity subscale score after four cycles of chemotherapy. Secondary endpoints included neurotoxicity evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 and the Eastern Cooperative Oncology Group neuropathy scale. All statistical tests were two-sided. Results In 183 evaluable patients, the GM1 group reported better mean Functional Assessment of Cancer Treatment Neurotoxicity subscale scores than patients in the placebo group after four cycles of chemotherapy (43.27, 95% confidence interval [CI] = 43.05 to 43.49 vs 34.34, 95% CI = 33.78 to 34.89; mean difference = 8.96, 95% CI = 8.38 to 9.54, P < .001). Grade 1 or higher peripheral neurotoxicity in Common Terminology Criteria for Adverse Events v4.0 scale was statistically significantly lower in the GM1 group (14.3% vs 100.0%, P < .001). Additionally, the GM1 group had a statistically significantly lower incidence of grade 1 or higher neurotoxicity assessed by Eastern Cooperative Oncology Group neuropathy scale sensory neuropathy (26.4% vs 97.8%, P < .001) and motor neuropathy subscales (20.9% vs 81.5%, P < .001). Conclusions The treatment with GM1 resulted in a reduction in the severity and incidence of TIPN after four cycles of taxane-containing chemotherapy in patients with breast cancer.

In SOFT study, subgroup analysis for hormone receptor-positive (HR+) breast cancer women younger than 35 years indicated better 5-year DFS in OFS+exemestane arm than OFS+tamoxifen. Since only about 11% of women included were younger than 35 years of age, this subgroup analysis result is underpowered. In addition, there still no specific randomized clinical trial focusing on endocrine treatment in women younger than 35 years of age. The purpose of this study is to compare the efficacy of gonadotropin releasing hormone agonists (GnRHa)+tamoxifen versus GnRHa+AIs in HR+ early breast cancer patients under age 35 with intermediate or high risk for disease recurrence. Study design This is a prospective, open label, multicentre, randomized controlled trial that compared the efficacy of GnRHa+tamoxifen versus GnRHa+AIs in HR+ early breast cancer patients under age 35 with intermediate or high risk for disease recurrence. This study was initiated by the first affiliated hospital of Sun Yat-sen university in 2016. Twenty-four hospitals in China participate in this trial. The protocol was approved by the appropriate regulatory and ethics authorities for each centre. This trial has been registrated at ClinicalTrials.gov. The NCT Number is NCT02914158. Criteria for patient eligibility: 1. Written informed consent must be signed. 2. ECOG≤2. 3. Histologically proven HR+ (ER≥1% by IHC) invasive breast cancer. 4. Age≤35, premenopausal. 5. No distant metastatic disease. 6. T≥2cm or with at least 1 axillary lymph node involved. 7. Patient must accept proper surgery, systemic therapy and radiation therapy if necessary. 8. Laboratory exam criteria for enrollment: hemoglobin ≥10g/dl, white blood cell ≥4,000/mm3, platelets ≥100,000/mm3, glutamic oxalacetic transaminase, glutamic-pyruvic transaminase, alkaline phosphatase ≤2 times upper limit of normal (ULN), total bilirubin, creatinine clearance rate ≤1.5 times ULN. Criteria for patient ineligibility: 1. Patients who are pregnant or lactating at the time of randomization or refuse to contraception.2. Patients who received organ transplantation. 3. Patients who have other malignant diseases within 5 years. 4. Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. 5. Patients with sever hepatic, renal, cardiovascular, respiratory, digestive diseases or uncontrolled diabetes. 6. Patients who participate in other clinical trials. 7. Patients who allergy to goserelin, leuprorelin, tamoxifen or AIs. Statistical analysis According to previous results, 5-year DFS for OFS+tamoxifen in HR+ breast cancer patients under age 35 with intermediate or high risk of disease recurrence was 73% vs. 81% for OFS+AIs. This trial designed 80% power to detect a between-group difference using a two-sample log-rank test (two-sided a=0.05). To allow for missing 10% data, the study planned to enroll 680 patients (340 patients for each group) in 5 years. The statistical design assumed that 197 primary end point events should occur during 5-year follow-up and OFS+AIs should decrease 30% DFS relative risk. The calculations were performed using PASS 11. Treatment details Patients enrolled are randomized 1:1 to two arms in 8 weeeks after surgery, adjuvant chemotherapy or radiation therapy. Goserelin 3.6mg or leuprorelin 3.75mg is injected subcutaneously every 28 days for 5 years. Arm A: Tamoxifen 20mg orally daily. Arm B: Exemestane 25mg, letrozole 2.5mg or anastrozole 1mg orally daily. Stratification Stratified by HER2 and axillary lymph node status. Primary end point: Disease free survival. Secondary end point: Overall survival. Invasive Breast Cancer Recurrence-Free Interval. Adverse Effects Rate. Citation Format: Zhen Shan, Nan Shao, Zhongyu yuan, Qianjun Chen, Anqin Zhang, Kun Wang, Ailing Zhang, Li Cai, Yuhua Song, Herui Yao, Hongmin Ma, Heng Huang, Jianwen Li, Yuanqi Zhang, Lehong Zhang, Jincai Zhong, Hui Liu, Zhiyong Wu, Li Zhao, Feihai Ling, Weixiong Yang, Rui Zhuo, Xiangyang Song, Ying Lin. Adjuvant ovarian suppression plus aromatase inhibitor or tamoxifen for hormone receptor-positive breast cancer in women younger than 35 (ASPAIT): A multicenter randomized clinical trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT1-04-01.

目的 探讨保留乳头、乳晕的乳房切除术(NSM)加一期假体乳房重建的安全性和术后美容效果.方法 本回顾性研究收集了2011年3月至2018年12月在广东省妇幼保健院接受NSM或全乳切除术联合一期假体乳房重建的81例乳腺癌患者的临床资料.其中,45例接受NSM+假体重建术,36例接受全乳切除+假体重建术.对全部患者进行随访,随访时间4～97个月,中位随访36个月.采用Harris乳房评价标准评价术后美容效果,采用乳腺癌患者生活质量测定量表(FACT-B)评价患者术后生活质量.采用χ2检验比较2组患者临床病理特征、美容效果优良率及术后并发症发生率;采用两独立样本非参数检验(Mann-Whitney U检验)比较2组患者术后美容效果;采用t检验比较2组患者生活质量评分;生存分析采用Kaplan-Meier法及log-rank检验.结果 NSM+假体重建组与全乳切除+假体重建组术后近期并发症和远期并发症发生率比较,差异均无统计学意义[24.4％(11/45)比22.2％(8/36),χ2=0.055,P=0.815;2.2％(1/45)比2.8％(1/36),P=1.000].全乳切除+假体重建组术后美容效果评价等级为优、良、中、差的例数分别为14、7、9、6例,NSM+假体重建组分别为20、18、5、2例,2组比较,差异无统计学意义(Z=-1.626,P=0.104).NSM+假体重建组的术后美容效果优良率为84.4％(38/45),全乳切除+假体重建组为58.3％(21/36),2组比较,差异有统计学意义(χ2=6.892,P=0.009).乳腺癌术后生活质量评分中,NSM+假体重建组的生理状况、社会/家庭状况及附加关注3个部分评分均明显优于全乳切除+假体重建组(t=2.720、2.585、3.160,P=0.009、0.013、0.004);2组的感情状况及功能状态比较,差异均无统计学意义(t=0.396、1.258,P=0.694、0.212).共3例患者出现复发转移,其中,NSM+假体重建组有2例(1例乳头、乳晕部位复发,1例为患侧腋窝淋巴结复发),全乳切除+假体重建组1例出现局部复发和纵隔淋巴结转移.2组患者DFS曲线比较,差异无统计学意义(χ2=0.398,P=0.528).2组5年OS率均为100％.结论 与全乳切除+假体重建术比较,NSM+假体重建术不增加术后并发症风险,具有较高的美容效果优良率及生活质量评分,在严格选择适应证的前提下,NSM+假体即刻乳房重建术也是一种可选择的手术方式.

507 Background: Triple-negative breast cancer (TNBC) has a relatively high relapse rate and poor outcome after standard therapy among all subtypes of breast cancer. Effective strategies to reduce risk of relapse and death are unmet medical needs. Methods: In this phase III trial, patients with operable TNBC were randomly assigned to receive metronomic capecitabine (650 mg/m2 twice daily continuously for one year) as maintenance therapy or observation after standard local and systemic treatment for curative intent. The primary end point was disease-free survival (DFS). Secondary end points included distant disease-free survival (DDFS), overall survival (OS) and safety. Results: A total of 434 patients were randomly assigned to capecitabine group (n = 221) or observation group (n = 213). At a median follow-up of 56.5 months, 5-year DFS was significantly better in capecitabine group than in observation group (83% vs. 73%, HR, 0.63; 95% CI, 0.42 to 0.96; p = 0.027). 5-year DDFS was also significantly better in capecitabine group than in observation group (85% vs. 76%, HR, 0.56; 95% CI, 0.37 to 0.90; p = 0.016). However, 5-year OS was not significantly different between two groups (85% vs. 81%, HR, 0.74; 95% CI, 0.47 to 1.18; p = 0.203). Two hundred and two (91.4%) of patients completed one year of capecitabine therapy as planned. The most common capecitabine-related adverse events were hand-foot syndrome (46%), leukopenia (24%), Hyperbilirubinemia (13%), gastrointestinal pain (7%) and elevated serum transaminases (5%). Conclusions: Maintenance therapy with metronomic capecitabine for one year following standard treatment significantly improved DFS in operable TNBC, which was safe and well tolerated. (SYSUCC-001, Clinical trial information: NCT01112826 .