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":"2025-11-10","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 : 2025-11-07DOI: 10.1016/j.breast.2025.104641
Martin Heidinger , Tibor A. Zwimpfer , Florian S. Halbeisen , Nadia Maggi , Marie Louise Frevert , Rama Kiblawi , Julie M. Loesch , Fabienne D. Schwab , Christian Kurzeder , Giacomo Montagna , Walter P. Weber
Background
Sentinel lymph node biopsy (SLNB) omission is safe in many patients with small, clinically and imaging node-negative (cN0/iN0), hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC). However, recruitment of the pivotal SOUND/INSEMA trials ended prior to approval of adjuvant cyclin-dependent kinase 4/6 inhibitors (CDK4/6i). Therefore, the impact of SLNB omission on eligibility for CDK4/6i and associated oncological outcomes is unknown.
Methods
Single-center, retrospective study including patients with ≤cT2, cN0/iN0, HR-positive/HER2-negative early BC who underwent breast-conserving surgery and SLNB between 01/2014-12/2024. CDK4/6i eligibility was based on monarchE inclusion criteria and FDA approval (abemaciclib) and NATALEE inclusion criteria (ribociclib). Predictors of CDK4/6i eligibility and node-positivity were identified using multivariable logistic regression analysis. Impact on invasive disease-free survival was estimated based on published number needed to treat values in stage II disease (abemaciclib 28; ribociclib 63).
Results
Among 309 patients, eligibility was 6.1 % (19/309), 3.2 % (10/309), and 7.8 % (24/309) for abemaciclib (monarchE), abemaciclib (FDA approval), and ribociclib based on node-criteria; consequently, the number of SLNB necessary to identify one eligible patient was 17 (95 %CI 11–27), 31 (95 %CI 17–64) and 13 (95 %CI 9–20). Lymphovascular invasion was identified as a predictor for CDK4/6i eligibility and node-positivity. Omitting SLNB could increase recurrences by 0.3 % (95 %CI 0.2–0.4), 0.2 % (95 %CI 0.1–0.3), and 0.2 % (95 %CI 0.1–0.2) due to missed treatment with abemaciclib (monarchE), abemaciclib (FDA approval), and ribociclib, respectively.
Conclusion
Omission of SLNB in patients with small HR-positive/HER2-negative tumors results in a missed indication for CDK4/6i in <8 % with minimal impact on recurrence.
背景：前哨淋巴结活检（SLNB）遗漏对于许多临床和影像学淋巴结阴性（cN0/iN0）、激素受体（HR）阳性、人表皮生长因子受体2 （HER2）阴性乳腺癌（BC）患者是安全的。然而，关键SOUND/INSEMA试验的招募在辅助细胞周期蛋白依赖性激酶4/6抑制剂（CDK4/6i）获批之前就结束了。因此，SLNB缺失对CDK4/6i治疗资格和相关肿瘤预后的影响尚不清楚。方法采用单中心回顾性研究，纳入2014年1月- 2024年12月期间接受保乳手术和SLNB的≤cT2、cN0/iN0、hr阳性/ her2阴性早期BC患者。CDK4/6i的资格基于monarchE纳入标准、FDA批准（abemaciclib）和NATALEE纳入标准（ribociclib）。使用多变量logistic回归分析确定CDK4/6i适格性和节点阳性的预测因子。对侵袭性无病生存的影响是基于II期疾病治疗价值所需的已发表数量（abemaciclib 28; ribociclib 63）。结果309例患者中，基于淋巴结标准的abemaciclib （monarchE）、abemaciclib （FDA批准）和ribociclib的适格率分别为6.1%（19/309）、3.2%（10/309）和7.8% (24/309)；因此，确定一名合格患者所需的SLNB数量为17 (95% CI 11-27), 31 （95% CI 17 - 64）和13 （95% CI 9-20）。淋巴血管侵袭被确定为CDK4/6i适格性和淋巴结阳性的预测因子。由于错过了abemaciclib （monarchE）、abemaciclib （FDA批准）和ribociclib的治疗，忽略SLNB可能会增加0.3% （95% CI 0.2 - 0.4）、0.2% （95% CI 0.1-0.3）和0.2% （95% CI 0.1-0.2）的复发率。结论在小的hr阳性/ her2阴性肿瘤患者中进行SLNB治疗会导致遗漏CDK4/6i指征的比例为8%，对复发的影响很小。
{"title":"Omission of sentinel lymph node biopsy in early stage luminal breast cancer: impact on adjuvant CDK4/6 inhibitor recommendation and oncological outcomes","authors":"Martin Heidinger , Tibor A. Zwimpfer , Florian S. Halbeisen , Nadia Maggi , Marie Louise Frevert , Rama Kiblawi , Julie M. Loesch , Fabienne D. Schwab , Christian Kurzeder , Giacomo Montagna , Walter P. Weber","doi":"10.1016/j.breast.2025.104641","DOIUrl":"10.1016/j.breast.2025.104641","url":null,"abstract":"<div><h3>Background</h3><div>Sentinel lymph node biopsy (SLNB) omission is safe in many patients with small, clinically and imaging node-negative (cN0/iN0), hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC). However, recruitment of the pivotal SOUND/INSEMA trials ended prior to approval of adjuvant cyclin-dependent kinase 4/6 inhibitors (CDK4/6i). Therefore, the impact of SLNB omission on eligibility for CDK4/6i and associated oncological outcomes is unknown.</div></div><div><h3>Methods</h3><div>Single-center, retrospective study including patients with ≤cT2, cN0/iN0, HR-positive/HER2-negative early BC who underwent breast-conserving surgery and SLNB between 01/2014-12/2024. CDK4/6i eligibility was based on monarchE inclusion criteria and FDA approval (abemaciclib) and NATALEE inclusion criteria (ribociclib). Predictors of CDK4/6i eligibility and node-positivity were identified using multivariable logistic regression analysis. Impact on invasive disease-free survival was estimated based on published number needed to treat values in stage II disease (abemaciclib 28; ribociclib 63).</div></div><div><h3>Results</h3><div>Among 309 patients, eligibility was 6.1 % (19/309), 3.2 % (10/309), and 7.8 % (24/309) for abemaciclib (monarchE), abemaciclib (FDA approval), and ribociclib based on node-criteria; consequently, the number of SLNB necessary to identify one eligible patient was 17 (95 %CI 11–27), 31 (95 %CI 17–64) and 13 (95 %CI 9–20). Lymphovascular invasion was identified as a predictor for CDK4/6i eligibility and node-positivity. Omitting SLNB could increase recurrences by 0.3 % (95 %CI 0.2–0.4), 0.2 % (95 %CI 0.1–0.3), and 0.2 % (95 %CI 0.1–0.2) due to missed treatment with abemaciclib (monarchE), abemaciclib (FDA approval), and ribociclib, respectively.</div></div><div><h3>Conclusion</h3><div>Omission of SLNB in patients with small HR-positive/HER2-negative tumors results in a missed indication for CDK4/6i in <8 % with minimal impact on recurrence.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104641"},"PeriodicalIF":7.9,"publicationDate":"2025-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145733547","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00682-4
Pat Garcia-Gonzalez
{"title":"ADVANCING ACCESS TO BREAST CANCER TREATMENT IN LMICS: INSIGHTS FROM THE HUMANITARIAN PACT TWO YEARS IN","authors":"Pat Garcia-Gonzalez","doi":"10.1016/S0960-9776(25)00682-4","DOIUrl":"10.1016/S0960-9776(25)00682-4","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Page S20"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448489","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00746-5
Derrick Bary Abila, Steven Kikonyogo, Ezra Anecho, Solomon Kibudde
{"title":"IMPACT OF LINAC ON RADIOTHERAPY SERVICES AT UCI: A RETROSPECTIVE ANALYSIS OF TREATMENT OUTCOMES AND SERVICE DELIVERY FOR BREAST CANCER PATIENTS","authors":"Derrick Bary Abila, Steven Kikonyogo, Ezra Anecho, Solomon Kibudde","doi":"10.1016/S0960-9776(25)00746-5","DOIUrl":"10.1016/S0960-9776(25)00746-5","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Pages S46-S47"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448644","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}
{"title":"ADVANCING PRECISION MEDICINE IN NIGERIA: THE ROLE OF PATIENT ENGAGEMENT AND EDUCATIONAL MATERIALS IN CARE ACTIVATION—A PILOT STUDY","authors":"Runcie C.W. Chidebe, Olushola Akapo, Sampson Ipiankama, Ozioma Uzodinma, Silvia Bornengo, Ifeoma Okoye, Helena Harnik","doi":"10.1016/S0960-9776(25)00705-2","DOIUrl":"10.1016/S0960-9776(25)00705-2","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Pages S28-S29"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145449164","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00701-5
Abena Addai, Beatrice Wiafe Addai, Benjamin Asante Oti
{"title":"HYPOTHETICAL MODEL: THE ROLE OF ADVANCED BREAST CANCER PATIENTS IN BRIDGING THE GENETIC DATA GAP IN LOW AND MIDDLE INCOME COUNTRIES","authors":"Abena Addai, Beatrice Wiafe Addai, Benjamin Asante Oti","doi":"10.1016/S0960-9776(25)00701-5","DOIUrl":"10.1016/S0960-9776(25)00701-5","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Page S28"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145449173","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00741-6
Junxiao Wang
{"title":"EFFICACY AND SAFETY OF POST-CDK4/6 INHIBITOR TREATMENT OPTIONS FOR HR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER: A NETWORK META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS","authors":"Junxiao Wang","doi":"10.1016/S0960-9776(25)00741-6","DOIUrl":"10.1016/S0960-9776(25)00741-6","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Pages S44-S45"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448383","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00742-8
Priscilla Osei, Beatrice Wiafe-Addai, Abena Wiafe
{"title":"CLINICAL CHARACTERISTICS OF 10 PATIENTS WITH A LOCALLY ADVANCED BREAST CANCER DIAGNOSIS AT THE PEACE AND LOVE HOSPITAL IN KUMASI, GHANA","authors":"Priscilla Osei, Beatrice Wiafe-Addai, Abena Wiafe","doi":"10.1016/S0960-9776(25)00742-8","DOIUrl":"10.1016/S0960-9776(25)00742-8","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Page S45"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448578","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 : 2025-11-01DOI: 10.1016/S0960-9776(25)00752-0
Laura Pinheiro, Caroline Zeng, Darima Dorzhieva, Lovely Joseph, Zori Hamilton, Kathryn Edick, Anne Marie Mercurio, Desiree Walker, Victoria Blinder, Shoshana Rosenberg
{"title":"IMPLEMENTATION AND EVALUATION OF RAISE (ROUTINE ASSESSMENT AND INTEGRATION OF SCREENING FOR EMPLOYMENT) FOR ADULTS WITH METASTATIC BREAST CANCER","authors":"Laura Pinheiro, Caroline Zeng, Darima Dorzhieva, Lovely Joseph, Zori Hamilton, Kathryn Edick, Anne Marie Mercurio, Desiree Walker, Victoria Blinder, Shoshana Rosenberg","doi":"10.1016/S0960-9776(25)00752-0","DOIUrl":"10.1016/S0960-9776(25)00752-0","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"83 ","pages":"Page S49"},"PeriodicalIF":7.9,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145448702","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}
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