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Nivolumab in combination with ipilimumab versus capecitabine as post-operative treatment for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy: a multicentre, randomized, open-label phase II trial – BREASTIMMUNE-03 Nivolumab联合易普利姆单抗与卡培他滨作为新辅助化疗后残留疾病的三阴性乳腺癌患者的术后治疗:一项多中心、随机、开放标签的II期试验- breasttimmune -03
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-21 DOI: 10.1016/j.breast.2025.104648
Olivier Trédan , Delphine Loirat , Sylvie Chabaud , Philippe Toussaint , Thierry Petit , Frédéric Viret , Christelle Levy , Aurélien Robert , Julien Grenier , Laura Mansi , Jean-Philippe Spano , Anne Patsouris , Olfa Derbel , Christelle Jouannaud , Jean Marc Ferrero , Jean Sébastien Frenel , Yann Molin , Louis Doublet , Pierre-Etienne Heudel , Jean-Yves Pierga , Thomas Bachelot

Background

Triple negative breast cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy (NAC) face high risk of recurrence. BREASTIMMUNE-03 trial evaluates the efficacy of nivolumab and ipilimumab combination compared to capecitabine as adjuvant treatment.

Methods

This multicentre, randomized open-label phase II trial included TNBC patients with Residual Cancer Burden (RCB) of class II-III after NAC and surgery, and allocated them to randomization (1:1) to receive nivolumab plus ipilimumab or capecitabine for 24 weeks. Randomization was stratified by center, ECOG performance status (PS) 0 or 1, and RCB Class. Primary endpoint was disease free survival (DFS), assessed in the intent-to-treat population. Safety analysis according to NCI-CTCAE V5.0 included all patients who received at least one dose of study drug.

Results

From July 2019 to October 2021, 95 patients were randomized to the nivolumab plus ipilimumab arm (NIVO + IPI n = 45), or to the capecitabine arm (CT n = 50). With a median follow-up of 34.3 (IQR 33–36) months, 39 events (relapse or death) were reported: 17 (38 %) for NIVO + IPI; 22 (44 %) for CT (HR 0.84, 95 %CI 0.45–1.59; log-rank test p-value 0.5938). 17 (38 %) patients in the NIVO + IPI arm prematurely discontinued treatment due to treatment-related adverse events (AEs), versus 7 (14 %) in the CT arm.

Conclusion

A 6-month post-operative nivolumab plus ipilimumab treatment did not significantly improve DFS compared to capecitabine in TNBC patients with RCB II-III and resulted in increased immune-mediated AEs. Despite premature trial termination, our results do not support nivolumab plus ipilimumab adjuvant treatment in this setting.

Trial registration

NCT03818685.
背景三阴性乳腺癌(TNBC)患者在新辅助化疗(NAC)后存在残留病变,面临着较高的复发风险。BREASTIMMUNE-03试验评估了纳武单抗和伊匹单抗联合使用与卡培他滨辅助治疗的疗效。方法这项多中心、随机、开放标签的II期临床试验纳入了NAC和手术后伴有II- iii级残留癌负担(RCB)的TNBC患者,并将其随机分配(1:1),接受纳鲁单抗联合伊匹单抗或卡培他滨治疗24周。随机分组按中心、ECOG表现状态(PS) 0或1和RCB分级进行分层。主要终点是在意向治疗人群中评估的无病生存期(DFS)。根据NCI-CTCAE V5.0进行的安全性分析包括所有接受至少一剂研究药物的患者。从2019年7月到2021年10月,95名患者被随机分配到尼武单抗+伊匹单抗组(NIVO + IPI n = 45)或卡培他滨组(CT n = 50)。中位随访34.3 (IQR 33-36)个月,报告了39例事件(复发或死亡):NIVO + IPI 17例(38%);CT 22例(44%)(HR 0.84, 95% CI 0.45-1.59; log-rank检验p值0.5938)。NIVO + IPI组中有17例(38%)患者因治疗相关不良事件(ae)过早停止治疗,而CT组中有7例(14%)患者过早停止治疗。结论与卡培他滨相比,术后6个月纳鲁单抗联合伊匹单抗治疗未显著改善RCB II-III型TNBC患者的DFS,并导致免疫介导的ae增加。尽管试验过早终止,我们的结果不支持在这种情况下纳武单抗加伊匹单抗辅助治疗。registrationNCT03818685审判。
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引用次数: 0
Subcutaneous pertuzumab-trastuzumab: Efficiency, safety, and the biosimilar horizon. 皮下帕妥珠单抗-曲妥珠单抗:有效性、安全性和生物仿制药水平。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-19 DOI: 10.1016/j.breast.2025.104651
Asim Armagan Aydin, Erkan Kayikcioglu
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引用次数: 0
Corrigendum to "Climate change impacts and sustainability integration among breast international group members" [The Breast Volume 81 June 2025 104469]. “气候变化影响和乳房国际小组成员的可持续性整合”的勘误表[The breast Volume 81 June 2025 104469]。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-17 DOI: 10.1016/j.breast.2025.104653
Seamus O'Reilly, Jessica Griffiths, Lisa Fox, Catherine S Weadick, Nay My Oo, Lucy Murphy, Robert O'Leary, Theodora Goulioti, Virginie Adam, Evangelia D Razis, Barbro Lindholm, Gustavo Werutsky, David Cameron, Judith Bliss
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引用次数: 0
Impact of treatment response to neoadjuvant chemotherapy on brain metastasis patterns and breast cancer prognosis 新辅助化疗治疗反应对脑转移模式和乳腺癌预后的影响。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-14 DOI: 10.1016/j.breast.2025.104650
Jihwan Yoo , Yoon Jin Cha , Sung Gwe Ahn , Joon Jeong , Hun Ho Park , Sung Jun Ahn , Bio Joo , Ji Hyun Park , Jee Hung Kim , Soong June Bae

Background

Brain metastases (BM) are a major cause of mortality in breast cancer. While pathologic complete response (pCR) after neoadjuvant chemotherapy is associated with favorable survival outcomes, its impact on BM development and prognosis remains unclear.

Methods

We retrospectively analyzed 1,244 patients with early-stage breast cancer who underwent neoadjuvant chemotherapy followed by surgery. Clinicopathological features, BM incidence, and survival outcomes were assessed. Propensity score matching (PSM) was applied to adjust for baseline differences. Gene expression profiling was performed in BM samples from pCR and non-pCR patients.

Results

Of these, 437 (35.1 %) patients achieved pCR and 52 (4.2 %) developed BM. In TNBC, non-pCR patients had a significantly higher BM rate (9.2 % vs. 3.3 %, P = 0.026), whereas no differences were observed in other subtypes. Patients with BM who achieved pCR were more likely to present with single brain lesion (42.9 % vs. 10.5 %, P = 0.016), undergo craniotomy (71.4 % vs. 31.6 %, P = 0.010), and less frequently had extracranial metastases (28.6 % vs. 73.7 %, P = 0.003). Median overall survival after BM was longer in the pCR (42 vs. 4 months, P = 0.002), and this benefit remained significant after PSM (43 vs. 10 months, P = 0.033). Transcriptomic analysis identified distinct molecular profiles, with upregulation of RPL27A and CTLA4 in pCR BM and non-pCR BM.

Conclusions

pCR was associated with lower metastatic burden and improved survival following BM diagnosis. Molecular differences between pCR and non-pCR BM suggest distinct mechanisms of metastatic evolution, suggesting the need for tailored surveillance and preventive strategies.
背景:脑转移(BM)是乳腺癌死亡的主要原因。虽然新辅助化疗后的病理完全缓解(pCR)与良好的生存结果相关,但其对脑转移的发展和预后的影响尚不清楚。方法:回顾性分析1244例接受新辅助化疗后手术治疗的早期乳腺癌患者。评估临床病理特征、脑转移发生率和生存结果。使用倾向评分匹配(PSM)来调整基线差异。在pCR和非pCR患者的BM样本中进行基因表达谱分析。结果:其中437例(35.1%)患者实现pCR, 52例(4.2%)发展为BM。在TNBC中,非pcr患者的BM率明显更高(9.2% vs 3.3%, P = 0.026),而在其他亚型中没有观察到差异。实现pCR的BM患者更有可能出现单脑病变(42.9%比10.5%,P = 0.016),接受开颅手术(71.4%比31.6%,P = 0.010),较少发生颅外转移(28.6%比73.7%,P = 0.003)。在pCR中,BM后的中位总生存期更长(42个月vs. 4个月,P = 0.002), PSM后这一优势仍然显著(43个月vs. 10个月,P = 0.033)。转录组学分析发现了不同的分子谱,在pCR BM和非pCR BM中RPL27A和CTLA4上调。结论:pCR与BM诊断后转移性负担降低和生存率提高相关。pCR和非pCR BM之间的分子差异表明转移进化的不同机制,这表明需要量身定制的监测和预防策略。
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引用次数: 0
Critical appraisal of a machine learning model for predicting internal mammary lymph node metastasis in breast cancer. 预测乳腺癌内乳淋巴结转移的机器学习模型的关键评价。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-14 DOI: 10.1016/j.breast.2025.104652
Kun Fang, Suxiao Jiang, Ping Zhang
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引用次数: 0
Early Ki67 change predicts prognosis and supports response-adapted therapy in breast cancer treated with neoadjuvant chemotherapy 早期Ki67变化预测预后并支持新辅助化疗治疗乳腺癌的反应适应治疗。
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-13 DOI: 10.1016/j.breast.2025.104649
Ying Zhang , Siyu Wu , Liang Xue , Yifan Xie , Juping Shen , Zhimin Shao , Guangyu Liu

Background

Early prediction of response to neoadjuvant chemotherapy (NACT) in breast cancer is critical for optimizing treatment strategies and improving outcomes. This study assessed the prognostic value of early Ki67 change (ΔKi67 %) via on-treatment core needle biopsy (CNB) in stratifying event-free survival (EFS) and informing potential treatment escalation.

Methods

In this prospective cohort study, 1388 breast cancer patients treated from 2013 to 2021 were randomly divided into training and validation sets (7:3 ratio). ΔKi67 % was calculated as the percentage change from baseline to on-treatment CNB after a median of two NACT cycles. K-means clustering determined an optimal 40 % cutoff classifying patients as poor (≤40 %) or good responders (>40 %). EFS was analyzed using Kaplan-Meier estimates, multivariable Cox models, and restricted mean survival time (RMST).

Results

Good responders had significantly superior 5-year EFS compared to poor responders in both training (78.8 % versus 62.4 %, p < 0.001) and validation (78.6 % versus 60.9 %, p = 0.001) sets. ΔKi67 % showed stronger stratification than imaging-based metrics in RMST analysis and remained an independent predictor after adjustment. Subgroup analyses suggested poor responders in the ER-negative/HER2-negative subgroup derived a 32.0 % 3-year EFS benefit from chemotherapy intensification. The 3-year survival benefit was 14.1 % in poor responders in the HER2-positive subtype with dual HER2 blockade, though these findings require further validation.

Conclusion

Early ΔKi67 % change using a 40 % cutoff via on-treatment CNB is a reliable prognostic predictor supporting response-adapted treatment tailoring, particularly in ER-negative/HER2-negative and HER2-positive populations.
背景:早期预测乳腺癌患者对新辅助化疗(NACT)的反应对于优化治疗策略和改善预后至关重要。本研究通过治疗中芯针活检(CNB)评估早期Ki67改变(ΔKi67 %)在分层无事件生存(EFS)和提示潜在的治疗升级中的预后价值。方法:本前瞻性队列研究将2013 - 2021年接受治疗的1388例乳腺癌患者随机分为训练组和验证组(7:3比例)。ΔKi67 %计算为中位数两个NACT周期后从基线到治疗时CNB的变化百分比。K-means聚类确定了将患者分类为不良(≤40%)或良好(> 40%)的最佳40%截断值。使用Kaplan-Meier估计、多变量Cox模型和限制平均生存时间(RMST)对EFS进行分析。结果:在两种训练中,良好反应者的5年EFS明显优于不良反应者(78.8%对62.4%,p)。结论:通过治疗中CNB使用40%的截止值,早期ΔKi67 %变化是一个可靠的预后预测指标,支持适应反应的治疗定制,特别是在er阴性/ her2阴性和her2阳性人群中。
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引用次数: 0
Health-related quality of life and fear of recurrence after early breast cancer treatment: Results from a cross-sectional survey 早期乳腺癌治疗后与健康相关的生活质量和对复发的恐惧:来自横断面调查的结果
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-13 DOI: 10.1016/j.breast.2025.104647
Paola Mosconi , Secondo Folli , Rosalba Miceli , Serena Scrudato , Massimiliano Gennaro , Gabriele Tinè , Maria Carmen De Santis , Cristina Ferraris , Gabriele Martelli , Immacolata Di Carlo , Ilaria Maugeri , Alessio Arata , Maria Grazia Carnevale , Chiara Listorti , Roberto Agresti , Claudia Borreani , Claudio Vernieri , Giancarlo Pruneri , Paolo Baili , Valentina Appierto , Giovanni Apolone

Background

The growing population of breast cancer survivors has raised attention to the long-term effects of treatment and follow-up. This study explored how survivors experience follow-up care and its impact on quality of life, focusing on fear of cancer recurrence (FCR), work and financial burden.

Methods

In this monocentric observational study, survivors completed a questionnaire including validated items from GIVIO, EORTC QLQ-C30, and FCR Inventory Short-Form. Fourteen domains were assessed. Scores were scaled 0–100, with higher values indicating better outcomes, except for FCR, where higher scores indicate greater concern. Data were stratified by age, time since diagnosis, education, income. Cluster analysis uncovered patterns of survivor experience across questionnaire domains.

Results

Of 1565 women scheduled for follow-up over six months, 681 (43.5 %) agreed to participate and, after excluding patients not fulfilling the protocol, and questionnaires with >50 % missing data, 656 entered the final analysis. Mean quality of life (73.3), physical (75.6), and social functioning (82.7) scored high, while emotional (55.6) and cognitive functioning (61.6) were lower. Satisfaction with care was mixed, with lower ratings for the national health system-level (56.8). FCR was moderate overall (38), with recurrent/intrusive thoughts in 2.9 % and 5.6 % of respondents. Lower income was significantly associated with worse outcomes across several domains, while no relevant differences were observed by age, education, or time since diagnosis. Cluster analysis revealed two distinct response profiles, clearly distinguished only by socioeconomic status.

Conclusions

Breast cancer survivors reported overall good levels of functioning, with lower scores in emotional and cognitive domains. Socioeconomic status was the only factor clearly associated with distinct response patterns.
背景:乳腺癌幸存者人数的增加引起了人们对治疗和随访的长期影响的关注。本研究探讨了幸存者如何经历随访护理及其对生活质量的影响,重点关注对癌症复发的恐惧(FCR),工作和经济负担。方法在这项单中心观察性研究中,幸存者完成了一份问卷,包括GIVIO、EORTC QLQ-C30和FCR量表短表中的验证项目。共评估了14个领域。分数从0到100分,分数越高表明结果越好,除了FCR,分数越高表明越受关注。数据按年龄、诊断后时间、教育程度、收入进行分层。聚类分析揭示了跨问卷域的幸存者经历模式。结果在1565名随访超过6个月的女性中,681名(43.5%)同意参与,在排除不符合方案的患者和50%缺失数据的问卷后,656名进入最终分析。平均生活质量(73.3分)、身体(75.6分)和社会功能(82.7分)得分较高,而情感(55.6分)和认知功能(61.6分)得分较低。对医疗服务的满意度参差不齐,对国家卫生系统水平的满意度较低(56.8分)。FCR总体上是中等的(38),2.9%和5.6%的受访者有反复/侵入性的想法。在几个领域中,收入较低与较差的结果显著相关,而年龄、教育程度或诊断后的时间没有观察到相关差异。聚类分析揭示了两种不同的反应概况,仅由社会经济地位明显区分。结论:乳腺癌幸存者总体表现良好,情感和认知领域得分较低。社会经济地位是唯一与不同的反应模式明显相关的因素。
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引用次数: 0
Eligibility for bilateral prophylactic mastectomy: An expert opinion study in the Netherlands 双侧预防性乳房切除术的资格:荷兰的专家意见研究
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-13 DOI: 10.1016/j.breast.2025.104645
L.P. Jansen , G.M. Kramer , E.G. Engelhardt , C.W. van der Zee , I. van de Beek , M.A. Adank , M.T.F.D. Vrancken Peeters , M.K. Schmidt , C.A. Drukker
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引用次数: 0
A UK study of the experiences, information needs and attitudes to clinical research among patients living with secondary breast cancer in the UK: A prospective co-developed study 一项关于英国继发性乳腺癌患者的经历、信息需求和临床研究态度的英国研究:一项前瞻性共同开发的研究
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-12 DOI: 10.1016/j.breast.2025.104644
Lesley Stephen , Janet Dunn , Claire Balmer , Nada Elbeltagi , Sophie Gasson , Ellen Copson , Carlo Palmieri

Background

Clinical research is key to improving the outcomes of patients with metastatic breast cancer (MBC). However, participation is low, with little data on patients’ attitudes and experiences of clinical research. This study aimed to explore the experience and attitude of patients in accessing and participating in clinical research in the UK.

Methods

An online survey, available between May and November 2021, was open to people living with MBC in the UK; this was complemented with by qualitative interviews.

Findings

768 responses were received (766 female, 2 male); median age was 51–60 years with 235 (31 %) having de novo disease. 660 (86 %) respondents were confident in their understanding of clinical research. Discussion of participation in research with an oncologist was reported by 173 (23 %) respondents. Accessing new treatments was the most common reason for study participants wanting to take part in research, 737 (96 %). Of the 107 (14 %) respondents who had taken part in clinical trials, 77 (72 %) reported a positive experience. 276 (36 %) would consider travelling to participate in research and 430 (56 %) would be more likely to travel if expenses were met. Themes emerging from the qualitative interviews include ‘lack of information’, ‘barriers to participation’ and ‘participants research priorities’.

Interpretation

This is the largest UK prospective study in regards to the views of MBC patients towards research. It demonstrates keenness to be involved in research, but participants face barriers as well as a lack of opportunity for participation. Key messages include importance of clinical staff in providing research information, need to develop patient accessible information, and to support travel costs. Improvements within the UK health care system are necessary to enable MBC patients to have equitable access to clinical research.
临床研究是改善转移性乳腺癌(MBC)患者预后的关键。然而,参与率很低,很少有关于患者对临床研究的态度和经验的数据。本研究旨在探讨英国患者获取和参与临床研究的经验和态度。方法在2021年5月至11月期间对英国MBC患者进行在线调查;此外,还进行了定性访谈。共收到768份回复(女性766份,男性2份);中位年龄为51-60岁,其中235例(31%)为新发疾病。660名(86%)受访者对自己对临床研究的理解充满信心。173名(23%)受访者报告了与肿瘤学家讨论参与研究的情况。获得新的治疗方法是研究参与者想要参加研究的最常见原因,737(96%)。在参与临床试验的107名(14%)受访者中,77名(72%)报告了积极的经历。276人(36%)会考虑出差参加研究,430人(56%)在费用得到满足的情况下更有可能出差。定性访谈的主题包括“缺乏信息”、“参与障碍”和“参与者的研究重点”。这是英国最大的关于MBC患者对研究看法的前瞻性研究。它显示了参与研究的热情,但参与者面临着障碍以及缺乏参与机会。关键信息包括临床工作人员在提供研究信息方面的重要性、开发患者可获取信息的必要性以及支持差旅费用。为了使MBC患者能够公平地获得临床研究,英国医疗保健系统的改进是必要的。
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引用次数: 0
“Silent Spring” revisited: Implications for breast cancer care 《寂静的春天》重访:对乳腺癌护理的启示
IF 7.9 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-11-11 DOI: 10.1016/j.breast.2025.104643
Seamus O'Reilly , Hans Wildiers , Alexandra Thomas
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引用次数: 0
期刊
Breast
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