Pub Date : 2026-02-01Epub Date: 2025-12-18DOI: 10.1016/j.breast.2025.104680
Jiyeong Kim , Shin Jeong Pak , Min Sung Chung , Chihwan David Cha
Background
s: Male breast cancer (MBC) accounts for less than 1 % of all breast cancer cases and is considered a rare disease. However, its incidence is steadily increasing. Despite this trend, comprehensive analyses comparing the clinicopathological characteristics and outcomes between male and female breast cancer (FBC) patients remain limited.
Methods
Using Korean National Health Insurance data (2007–2023), we analyzed 368,577 patients (1437 men; 367,140 women). Age-standardized incidence rates (ASR), clinicopathological features (age at diagnosis, Charlson Comorbidity Index), treatment modalities, recurrence rates, and mortality outcomes were compared between MBC and FBC. Multivariate Cox proportional hazards regression was performed to assess the association of sex with recurrence and survival.
Results
ASR of MBC doubled (0.59–1.19), while female breast cancer (FBC) increased from 67.6 to 157.3. Male patients were older at diagnosis (64 vs. 51 years, p < 0.001), had higher comorbidity (p < 0.001), and showed worse outcomes. Recurrence was more frequent in men (14.3 % vs. 12.5 %, p = 0.038) as was mortality (31.3 % vs. 11.1 %, p < 0.001). Multivariate analysis confirmed male sex as a significant risk factor for recurrence (p = 0.010).
Conclusion
Despite its rarity, MBC incidence is increasing, with distinct clinicopathological features and poorer prognosis compared to FBC. These findings emphasize the need for sex-specific strategies and inclusion of male patients in breast cancer research.
{"title":"Korean nationwide analysis of male breast Cancer: Incidence trends, treatment disparities, and survival compared with female patients","authors":"Jiyeong Kim , Shin Jeong Pak , Min Sung Chung , Chihwan David Cha","doi":"10.1016/j.breast.2025.104680","DOIUrl":"10.1016/j.breast.2025.104680","url":null,"abstract":"<div><h3>Background</h3><div>s: Male breast cancer (MBC) accounts for less than 1 % of all breast cancer cases and is considered a rare disease. However, its incidence is steadily increasing. Despite this trend, comprehensive analyses comparing the clinicopathological characteristics and outcomes between male and female breast cancer (FBC) patients remain limited.</div></div><div><h3>Methods</h3><div>Using Korean National Health Insurance data (2007–2023), we analyzed 368,577 patients (1437 men; 367,140 women). Age-standardized incidence rates (ASR), clinicopathological features (age at diagnosis, Charlson Comorbidity Index), treatment modalities, recurrence rates, and mortality outcomes were compared between MBC and FBC. Multivariate Cox proportional hazards regression was performed to assess the association of sex with recurrence and survival.</div></div><div><h3>Results</h3><div>ASR of MBC doubled (0.59–1.19), while female breast cancer (FBC) increased from 67.6 to 157.3. Male patients were older at diagnosis (64 vs. 51 years, p < 0.001), had higher comorbidity (p < 0.001), and showed worse outcomes. Recurrence was more frequent in men (14.3 % vs. 12.5 %, p = 0.038) as was mortality (31.3 % vs. 11.1 %, p < 0.001). Multivariate analysis confirmed male sex as a significant risk factor for recurrence (p = 0.010).</div></div><div><h3>Conclusion</h3><div>Despite its rarity, MBC incidence is increasing, with distinct clinicopathological features and poorer prognosis compared to FBC. These findings emphasize the need for sex-specific strategies and inclusion of male patients in breast cancer research.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104680"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910403","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-10DOI: 10.1016/j.breast.2025.104672
Christina Engebrethsen , Synnøve Yndestad , Mari E. Rasmussen , Emiel A.M. Janssen , Bjørnar Gilje , Egil S. Blix , Helge Espelid , Steinar Lundgren , Jürgen Geisler , Laura Minsaas , Reidun Lillestøl , Hildegunn S. Aase , Turid Aas , Per E. Lønning , Hans P. Eikesdal , Stian Knappskog
Background
While neoadjuvant endocrine therapy (NET), with or without a CDK4/6 inhibitor, is an established treatment option for estrogen receptor-positive breast cancers, optimal patient selection and second-line treatment for non-responders remain uncertain.
Methods
In the open-label, phase 2 PETREMAC trial (NCT02624973), pre- and postmenopausal patients with large T2 (>4 cm) or locally advanced ER/PGR>50 %, HER2-, and TP53 wild-type breast cancers received NET (tamoxifen + goserelin for premenopausal and letrozole for postmenopausal patients). Palbociclib was added if the Ki67 reduction was ≤50 % after 14 days. Neoadjuvant chemotherapy (NAC) was introduced if NET ± palbociclib failed to reduce Ki67 sufficiently or if there was no objective response on MRI after 24 weeks. Tumor biopsies underwent targeted sequencing of 360 cancer-related genes and subsequent gene expression profiling.
Results
Among 88 patients, the median tumor size was 48 mm (range 16–140 mm). NET alone reduced Ki67 > 50 % in 49/88 (56 %) of evaluable tumors. Adding palbociclib yielded a Ki67 reduction >50 % in 24/34 (71 %) of tumors where neoadjuvant endocrine therapy alone failed to suppress Ki67, providing a Ki67 reduction of >50 % in a total of 72/88 (82 %) of patients. NAC was administered to 34/88 (39 %) due to inadequate Ki67 response or lack of MRI response. Overall, 70 % achieved a pre-surgical objective response. Pathological complete response was seen in 3/84 patients. Postmenopausal status (p = 0.005) and invasive lobular carcinoma (p = 0.02) predicted Ki67-based response to NET.
Conclusion
Sequential NET with palbociclib, limiting NAC to non-responders, is a feasible strategy for ER/PGR>50 %, HER2-, TP53 wild-type breast cancers.
{"title":"Neoadjuvant endocrine therapy with sequential palbociclib and chemotherapy based on Ki67 status in stage II-III breast cancer: An open-label, phase II study","authors":"Christina Engebrethsen , Synnøve Yndestad , Mari E. Rasmussen , Emiel A.M. Janssen , Bjørnar Gilje , Egil S. Blix , Helge Espelid , Steinar Lundgren , Jürgen Geisler , Laura Minsaas , Reidun Lillestøl , Hildegunn S. Aase , Turid Aas , Per E. Lønning , Hans P. Eikesdal , Stian Knappskog","doi":"10.1016/j.breast.2025.104672","DOIUrl":"10.1016/j.breast.2025.104672","url":null,"abstract":"<div><h3>Background</h3><div>While neoadjuvant endocrine therapy (NET), with or without a CDK4/6 inhibitor, is an established treatment option for estrogen receptor-positive breast cancers, optimal patient selection and second-line treatment for non-responders remain uncertain.</div></div><div><h3>Methods</h3><div>In the open-label, phase 2 PETREMAC trial (NCT02624973), pre- and postmenopausal patients with large T2 (>4 cm) or locally advanced ER/PGR>50 %, HER2-, and <em>TP53</em> wild-type breast cancers received NET (tamoxifen + goserelin for premenopausal and letrozole for postmenopausal patients). Palbociclib was added if the Ki67 reduction was ≤50 % after 14 days. Neoadjuvant chemotherapy (NAC) was introduced if NET ± palbociclib failed to reduce Ki67 sufficiently or if there was no objective response on MRI after 24 weeks. Tumor biopsies underwent targeted sequencing of 360 cancer-related genes and subsequent gene expression profiling.</div></div><div><h3>Results</h3><div>Among 88 patients, the median tumor size was 48 mm (range 16–140 mm). NET alone reduced Ki67 > 50 % in 49/88 (56 %) of evaluable tumors. Adding palbociclib yielded a Ki67 reduction >50 % in 24/34 (71 %) of tumors where neoadjuvant endocrine therapy alone failed to suppress Ki67, providing a Ki67 reduction of >50 % in a total of 72/88 (82 %) of patients. NAC was administered to 34/88 (39 %) due to inadequate Ki67 response or lack of MRI response. Overall, 70 % achieved a pre-surgical objective response. Pathological complete response was seen in 3/84 patients. Postmenopausal status (p = 0.005) and invasive lobular carcinoma (p = 0.02) predicted Ki67-based response to NET.</div></div><div><h3>Conclusion</h3><div>Sequential NET with palbociclib, limiting NAC to non-responders, is a feasible strategy for ER/PGR>50 %, HER2-, <em>TP53</em> wild-type breast cancers.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104672"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-21DOI: 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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Pub Date : 2026-02-01Epub Date: 2025-11-24DOI: 10.1016/j.breast.2025.104665
Renata Duchnowska , Katarzyna Soter , Katarzyna Pogoda , Jolanta Smok-Kalwat , Aleksandra Grela-Wojewoda , Karolina Winsko-Szczęsnowicz , Agnieszka Kowalewska-Felczak , Marek Szwiec , Iwona Danielewicz , Joanna Streb , Tomasz Lewandowski , Bartosz Szymanowski , Joanna Kiszka , Barbara Radecka , Ewa Kalinka , Bartosz K. Sobocki , Maria Litwiniuk , Aleksandra Łacko , Anna Bałata , Justyna Żubrowska , Jacek Jassem
Background
Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) are the standard first- and second-line treatments for hormone receptor-positive (HR+), HER2-negative (HER2−) advanced breast cancer (ABC). Real-world data (RWD) may inform the optimal use of these agents in routine practice.
Patients and methods
The multicenter, population-based POLiCDK study compared progression-free survival (PFS), second PFS, and overall survival (OS) in ABC patients with HR+/HER2− ABC treated with palbociclib (PAL), ribociclib (RIB), or abemaciclib (ABE) in first- or second-line ET settings at 16 Polish centers between September 2017 and January 2025. Analyses were stratified by endocrine sensitivity/resistance, and stabilized inverse probability of treatment weighting was used to balance baseline characteristics.
Results
Among 2063 patients (701 PAL, 968 RIB, 394 ABE), 1583 (76.7 %) received CDK4/6i in the first-line and 480 (23.3 %) in the second-line setting. Overall, 927 (44.9 %) had de novo ABC; 819 (39.7 %) were endocrine-naïve, 158 (8.9 %) primary resistant, and 808 (39.2 %) secondary resistant. Median follow-up was 35.9, 24.1, and 21.4 months for PAL, RIB, and ABE, respectively. In endocrine-naïve patients, PFS did not differ significantly between CDK4/6i combined with aromatase inhibitors (AIs). In secondary endocrine-resistant disease, RIB and ABE outperformed PAL with AI combinations, whereas outcomes with fulvestrant were similar. In second-line therapy, all three CDK4/6i showed comparable results. Adjusted hazard ratios confirmed these trends without consistent superiority of any single agent.
Conclusions
Endocrine sensitivity/resistance and ET partner were major determinants of outcome with CDK4/6i plus ET in HR+/HER2− ABC, informing individualized treatment selection and sequencing.
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Pub Date : 2026-02-01Epub Date: 2025-11-24DOI: 10.1016/j.breast.2025.104666
Maartje A.C. Schreurs , Muriel A. Adank , Bernadette A.M. Heemskerk-Gerritsen , Antoinette Hollestelle , Nyrée Smallenbroek , Christi J. van Asperen , Margreet G.E.M. Ausems , Irma van de Beek , Geertruida H. de Bock , Ingrid Boere , Liselotte P. van Hest , Kim J.A.F. van Kaam , Linda de Munck , Janet R. Vos , Agnes Jager , Marjanka K. Schmidt , Maartje J. Hooning , Hebon
Purpose
Germline CHEK2 c.1100delC-associated breast cancer (BC) patients have been reported with worse prognosis than patients without the variant. However, results are based on older cohorts and treatment regimens. As part of the Hebon-CHEK2 study, we aim to study prognosis in a Dutch cohort of genetically tested ER-positive BC patients diagnosed from 2006 onwards.
Methods
All patients underwent genetic testing based on personal and family history risk, and data on BC outcomes were collected. Hazard ratios (HRs) and 95 % confidence intervals (CI) for the association of CHEK2-status with prognosis were estimated via delayed entry Cox regression models, adjusted for age and year of diagnosis, tumor size, nodal status, and primary treatment regimens. Furthermore, we meta-analyzed our results with previous studies.
Results
We included 480 CHEK2 BC patients and 944 BC patients without the variant. Median follow-up was 6.0 years. Heterozygotes were more often diagnosed with small tumors, and lymph node positive disease. No significant difference was found for recurrent disease and distant disease-free survival, neither before 5 years (HR = 0.73; 95 %CI = 0.35–1.53 and HR = 0.99; 95 %CI = 0.44–2.21, respectively), nor after 5 years follow-up (HR = 0.29; 95 %CI = 0.06–1.28 and HR = 0.39; 95 %CI = 0.10–1.39, respectively). Also no significant difference in BC-specific survival (HR = 0.77; 95 %CI = 0.42–1.39) or overall survival (HR = 0.69; 95 %CI = 0.43–1.08) was found. Meta-analysis of our results with previous studies showed a worse BC-specific survival for heterozygotes.
Conclusion
In our study, with more recent years of diagnosis and treatment, we found no difference in prognosis, as opposed to previous studies. Further research is needed to validate our findings.
目的:据报道,种系CHEK2 c. 1100delc相关乳腺癌(BC)患者的预后比没有该变异的患者差。然而,结果是基于年龄较大的队列和治疗方案。作为Hebon-CHEK2研究的一部分,我们的目标是研究2006年以后诊断的基因检测er阳性BC患者的预后。方法对所有患者进行基于个人和家族史风险的基因检测,收集BC预后数据。通过延迟进入Cox回归模型估计chek2状态与预后相关的风险比(hr)和95%置信区间(CI),并根据年龄和诊断年份、肿瘤大小、淋巴结状态和主要治疗方案进行调整。此外,我们将我们的结果与之前的研究进行了meta分析。结果我们纳入了480例CHEK2 BC患者和944例无该变异的BC患者。中位随访时间为6.0年。杂合子更常被诊断为小肿瘤和淋巴结阳性疾病。5年前(HR = 0.73, 95% CI = 0.35-1.53, HR = 0.99, 95% CI = 0.44-2.21)和5年后(HR = 0.29, 95% CI = 0.06-1.28, HR = 0.39, 95% CI = 0.10-1.39),复发性疾病和远处无病生存率均无显著差异。bc特异性生存率(HR = 0.77; 95% CI = 0.42-1.39)或总生存率(HR = 0.69; 95% CI = 0.43-1.08)也无显著差异。我们的结果与先前研究的荟萃分析显示,杂合子的bc特异性生存率较差。结论在我们的研究中,随着近年来的诊断和治疗,我们发现预后没有差异,这与以往的研究相反。需要进一步的研究来验证我们的发现。
{"title":"Outcomes for ER-positive CHEK2 c.1100delC breast cancer patients compared with breast cancer patients without the variant","authors":"Maartje A.C. Schreurs , Muriel A. Adank , Bernadette A.M. Heemskerk-Gerritsen , Antoinette Hollestelle , Nyrée Smallenbroek , Christi J. van Asperen , Margreet G.E.M. Ausems , Irma van de Beek , Geertruida H. de Bock , Ingrid Boere , Liselotte P. van Hest , Kim J.A.F. van Kaam , Linda de Munck , Janet R. Vos , Agnes Jager , Marjanka K. Schmidt , Maartje J. Hooning , Hebon","doi":"10.1016/j.breast.2025.104666","DOIUrl":"10.1016/j.breast.2025.104666","url":null,"abstract":"<div><h3>Purpose</h3><div>Germline <em>CHEK2</em> c.1100delC-associated breast cancer (BC) patients have been reported with worse prognosis than patients without the variant. However, results are based on older cohorts and treatment regimens. As part of the Hebon-CHEK2 study, we aim to study prognosis in a Dutch cohort of genetically tested ER-positive BC patients diagnosed from 2006 onwards.</div></div><div><h3>Methods</h3><div>All patients underwent genetic testing based on personal and family history risk, and data on BC outcomes were collected. Hazard ratios (HRs) and 95 % confidence intervals (CI) for the association of <em>CHEK2</em>-status with prognosis were estimated via delayed entry Cox regression models, adjusted for age and year of diagnosis, tumor size, nodal status, and primary treatment regimens. Furthermore, we meta-analyzed our results with previous studies.</div></div><div><h3>Results</h3><div>We included 480 <em>CHEK2</em> BC patients and 944 BC patients without the variant. Median follow-up was 6.0 years. Heterozygotes were more often diagnosed with small tumors, and lymph node positive disease. No significant difference was found for recurrent disease and distant disease-free survival, neither before 5 years (HR = 0.73; 95 %CI = 0.35–1.53 and HR = 0.99; 95 %CI = 0.44–2.21, respectively), nor after 5 years follow-up (HR = 0.29; 95 %CI = 0.06–1.28 and HR = 0.39; 95 %CI = 0.10–1.39, respectively). Also no significant difference in BC-specific survival (HR = 0.77; 95 %CI = 0.42–1.39) or overall survival (HR = 0.69; 95 %CI = 0.43–1.08) was found. Meta-analysis of our results with previous studies showed a worse BC-specific survival for heterozygotes.</div></div><div><h3>Conclusion</h3><div>In our study, with more recent years of diagnosis and treatment, we found no difference in prognosis, as opposed to previous studies. Further research is needed to validate our findings.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104666"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Involving those with a lived experience of the relevant condition in the design of clinical research ensures that studies address real-world needs and priorities, enabling more relevant, ethical, and impactful outcomes. In 2019, the Breast International Group (BIG) established the BIG Patient Partnership to facilitate the meaningful involvement of people affected by breast cancer in the design and conduct of its studies. The members provide a strong international patient voice in academic breast cancer research. The partnership is based on 4 pillars: foundational and ongoing training, meaningful and systematic involvement, patients as a strategic driving force in BIG's research, and promoting the value of the patients' voice in research. In this paper, we describe a model to enable performing transnational clinical research for and with patient partners. We hope to inspire organizations and people who are burdened by cancer from different cultural backgrounds to develop an interactive, engaging, and empowering process for researchers and patient partners to work together.
{"title":"The Breast International Group (BIG) Patient Partnership: Embedding meaningful patient involvement in the design and conduct of breast cancer clinical research","authors":"Carmela Caballero , Virginie Adam , Orsolya Birta , Lydie Meheus , Judy Needham , Christine Hodgdon , Leslie Gilhams , Concepcion Biurrun , Mairead MacKenzie , Tanja Spanic , Hilary Stobart , Lynda Belhadi , Julia Maués , Ana Casas , Eva Schumacher-Wulf , Carolyn Straehle , Seamus O'Reilly , David Cameron , Martine Piccart , Judith Bliss , Boon Chua","doi":"10.1016/j.breast.2025.104642","DOIUrl":"10.1016/j.breast.2025.104642","url":null,"abstract":"<div><div>Involving those with a lived experience of the relevant condition in the design of clinical research ensures that studies address real-world needs and priorities, enabling more relevant, ethical, and impactful outcomes. In 2019, the Breast International Group (BIG) established the BIG Patient Partnership to facilitate the meaningful involvement of people affected by breast cancer in the design and conduct of its studies. The members provide a strong international patient voice in academic breast cancer research. The partnership is based on 4 pillars: foundational and ongoing training, meaningful and systematic involvement, patients as a strategic driving force in BIG's research, and promoting the value of the patients' voice in research. In this paper, we describe a model to enable performing transnational clinical research for and <em>with</em> patient partners. We hope to inspire organizations and people who are burdened by cancer from different cultural backgrounds to develop an interactive, engaging, and empowering process for researchers and patient partners to work together.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104642"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145562810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-11-18DOI: 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
{"title":"Corrigendum to “Climate change impacts and sustainability integration among breast international group members” [The Breast Volume 81 June 2025 104469]","authors":"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","doi":"10.1016/j.breast.2025.104653","DOIUrl":"10.1016/j.breast.2025.104653","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104653"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145547880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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.
{"title":"Early Ki67 change predicts prognosis and supports response-adapted therapy in breast cancer treated with neoadjuvant chemotherapy","authors":"Ying Zhang , Siyu Wu , Liang Xue , Yifan Xie , Juping Shen , Zhimin Shao , Guangyu Liu","doi":"10.1016/j.breast.2025.104649","DOIUrl":"10.1016/j.breast.2025.104649","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104649"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145556338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-11DOI: 10.1016/j.breast.2025.104674
Peter H. Wessels , Sten Cornellisen , Kim Monkhorst , Gabe S. Sonke , Annegien Broeks , Dorothe Linders , Daan van den Broek , Mirjam C. Boelens , Dieta Brandsma
Purpose
To study differences in genetic alterations between primary breast cancer, systemic metastases, and cerebrospinal fluid (CSF) in patients with leptomeningeal metastases (LM).
Material and methods
Breast cancer patients with confirmed or probable LM and available primary tumor tissue were selected from a CSF-biobank study of the Netherlands Cancer Institute. Genetic analysis of cell-free DNA (cfDNA) in CSF and tissue from the primary tumor and/or systemic metastases was performed using Next Generation Sequencing (NGS). In patients with HR+/HER2-breast cancer, CSF and tumor tissues were also tested for ESR1 mutations with Sanger sequencing.
Results
27 breast cancer patients with LM (n = 23 confirmed LM; n = 4 probable LM) were included in the study. Fourteen patients had triple negative (TN), 11 HR+/HER2-and 3 HER2+ breast cancer. CSF-only genetic alterations were observed in 5 (20 %) of 25 evaluable patients. The majority of these genetic alterations were found in the PTEN-PI3K-AKT pathway, which were present in 3 of 14 evaluable patients with a TN breast cancer subtype (21 %) and in one patient wit HER2+ breastcancer. In one HR+/HER2+ patient, an ESR1 mutation was present in both CSF and systemic metastases, while it was absent in the primary tumor. All genetic alterations that were observed in either the primary tumor or systemic metastases were also observed in the CSF.
Conclusion
In 20 % of breast cancer patients with LM, genetic alterations in the CSF were discordant from the primary tumor and/or systemic metastases. These genetic alterations involved in particular the PTEN-PI3K-AKT pathway in TN breast cancer. No ESR1 mutation limited to CSF only was found in HR+/HER2-breast cancer. Divergence of genetic alterations in LM from breast cancer must be considered for optimization of future target treatment strategy.
{"title":"Divergence of DNA tumor mutations in cerebrospinal fluid in metastatic breast cancer patients with leptomeningeal metastases","authors":"Peter H. Wessels , Sten Cornellisen , Kim Monkhorst , Gabe S. Sonke , Annegien Broeks , Dorothe Linders , Daan van den Broek , Mirjam C. Boelens , Dieta Brandsma","doi":"10.1016/j.breast.2025.104674","DOIUrl":"10.1016/j.breast.2025.104674","url":null,"abstract":"<div><h3>Purpose</h3><div>To study differences in genetic alterations between primary breast cancer, systemic metastases, and cerebrospinal fluid (CSF) in patients with leptomeningeal metastases (LM).</div></div><div><h3>Material and methods</h3><div>Breast cancer patients with confirmed or probable LM and available primary tumor tissue were selected from a CSF-biobank study of the Netherlands Cancer Institute. Genetic analysis of cell-free DNA (cfDNA) in CSF and tissue from the primary tumor and/or systemic metastases was performed using Next Generation Sequencing (NGS). In patients with HR+/HER2-breast cancer, CSF and tumor tissues were also tested for ESR1 mutations with Sanger sequencing.</div></div><div><h3>Results</h3><div>27 breast cancer patients with LM (n = 23 confirmed LM; n = 4 probable LM) were included in the study. Fourteen patients had triple negative (TN), 11 HR+/HER2-and 3 HER2+ breast cancer. CSF-only genetic alterations were observed in 5 (20 %) of 25 evaluable patients. The majority of these genetic alterations were found in the PTEN-PI3K-AKT pathway, which were present in 3 of 14 evaluable patients with a TN breast cancer subtype (21 %) and in one patient wit HER2+ breastcancer. In one HR+/HER2+ patient, an ESR1 mutation was present in both CSF and systemic metastases, while it was absent in the primary tumor. All genetic alterations that were observed in either the primary tumor or systemic metastases were also observed in the CSF.</div></div><div><h3>Conclusion</h3><div>In 20 % of breast cancer patients with LM, genetic alterations in the CSF were discordant from the primary tumor and/or systemic metastases. These genetic alterations involved in particular the PTEN-PI3K-AKT pathway in TN breast cancer. No ESR1 mutation limited to CSF only was found in HR+/HER2-breast cancer. Divergence of genetic alterations in LM from breast cancer must be considered for optimization of future target treatment strategy.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104674"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910427","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-14DOI: 10.1016/j.breast.2026.104700
Anneke Kastelein , Laura Kervezee , Dieuwke R. Mink van der Molen , Daniel J. Evers , Carmen C. van der Pol , Annemiek Doeksen , N.H. Chavannes , Hans Gelderblom , Jacques Neefjes , Helena M. Verkooijen , Anne M. May
Background
Cancer-related fatigue is a common and profound side effect of cancer treatment. The specific impacts of different classes of chemotherapy remains understudied. This study aimed to compare the trajectory of fatigue between breast cancer patients treated with anthracycline-based versus non-anthracycline-based regimens over a period of 4 years.
Methods
Data were obtained from the Dutch UMBRELLA cohort. Included were breast cancer patients treated with (neo)adjuvant chemotherapy, categorized as anthracycline-containing vs. non-anthracycline-containing. Fatigue was measured using the Multidimensional Fatigue Inventory-20 and the fatigue scale of the EORTC QLQ-C30. A total of 1155 patients were included: 971 received anthracycline-based chemotherapy, and 184 received non-anthracycline-based chemotherapy. Linear mixed-effects models were employed to analyse time-by-treatment interactions for different dimensions of fatigue.
Results
The fatigue trajectories differed significantly between treatment groups for general and physical fatigue. Pairwise comparisons indicate that anthracycline-treated patients reported higher levels of general fatigue and physical fatigue as well as reduced activity in the first six months after start of treatment. Notably, patients treated with non-anthracycline-based regimens reported better recovery over time, with significantly lower fatigue levels at 42–48 months compared to anthracyclines-treated patients, as measured by both the MFI-20 and the fatigue scale of the EORTC QLQ-C30.
Conclusion
These observations suggest that (neo)adjuvant anthracycline-based chemotherapy in breast cancer patients is associated with higher levels of fatigue during treatment as well as a prolonged burden of fatigue. Treatment tailored fatigue management strategies may be particularly useful for patients undergoing anthracycline-based chemotherapy.
{"title":"The trajectory of fatigue over time in breast cancer patients treated with chemotherapy: exploring the effect of anthracycline-based chemotherapy","authors":"Anneke Kastelein , Laura Kervezee , Dieuwke R. Mink van der Molen , Daniel J. Evers , Carmen C. van der Pol , Annemiek Doeksen , N.H. Chavannes , Hans Gelderblom , Jacques Neefjes , Helena M. Verkooijen , Anne M. May","doi":"10.1016/j.breast.2026.104700","DOIUrl":"10.1016/j.breast.2026.104700","url":null,"abstract":"<div><h3>Background</h3><div>Cancer-related fatigue is a common and profound side effect of cancer treatment. The specific impacts of different classes of chemotherapy remains understudied. This study aimed to compare the trajectory of fatigue between breast cancer patients treated with anthracycline-based versus non-anthracycline-based regimens over a period of 4 years.</div></div><div><h3>Methods</h3><div>Data were obtained from the Dutch UMBRELLA cohort. Included were breast cancer patients treated with (neo)adjuvant chemotherapy, categorized as anthracycline-containing vs. non-anthracycline-containing. Fatigue was measured using the Multidimensional Fatigue Inventory-20 and the fatigue scale of the EORTC QLQ-C30. A total of 1155 patients were included: 971 received anthracycline-based chemotherapy, and 184 received non-anthracycline-based chemotherapy. Linear mixed-effects models were employed to analyse time-by-treatment interactions for different dimensions of fatigue.</div></div><div><h3>Results</h3><div>The fatigue trajectories differed significantly between treatment groups for general and physical fatigue. Pairwise comparisons indicate that anthracycline-treated patients reported higher levels of general fatigue and physical fatigue as well as reduced activity in the first six months after start of treatment. Notably, patients treated with non-anthracycline-based regimens reported better recovery over time, with significantly lower fatigue levels at 42–48 months compared to anthracyclines-treated patients, as measured by both the MFI-20 and the fatigue scale of the EORTC QLQ-C30.</div></div><div><h3>Conclusion</h3><div>These observations suggest that (neo)adjuvant anthracycline-based chemotherapy in breast cancer patients is associated with higher levels of fatigue during treatment as well as a prolonged burden of fatigue. Treatment tailored fatigue management strategies may be particularly useful for patients undergoing anthracycline-based chemotherapy.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104700"},"PeriodicalIF":7.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146008930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}