Pub 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。
{"title":"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","authors":"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","doi":"10.1016/j.breast.2025.104648","DOIUrl":"10.1016/j.breast.2025.104648","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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), <em>versus</em> 7 (14 %) in the CT arm.</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Trial registration</h3><div>NCT03818685.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104648"},"PeriodicalIF":7.9,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615858","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 : 2025-11-14DOI: 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.
{"title":"Impact of treatment response to neoadjuvant chemotherapy on brain metastasis patterns and breast cancer prognosis","authors":"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","doi":"10.1016/j.breast.2025.104650","DOIUrl":"10.1016/j.breast.2025.104650","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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 %, <em>P</em> = 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 %, <em>P</em> = 0.016), undergo craniotomy (71.4 % vs. 31.6 %, <em>P</em> = 0.010), and less frequently had extracranial metastases (28.6 % vs. 73.7 %, <em>P</em> = 0.003). Median overall survival after BM was longer in the pCR (42 vs. 4 months, <em>P</em> = 0.002), and this benefit remained significant after PSM (43 vs. 10 months, <em>P</em> = 0.033). Transcriptomic analysis identified distinct molecular profiles, with upregulation of RPL27A and CTLA4 in pCR BM and non-pCR BM.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104650"},"PeriodicalIF":7.9,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145556382","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":"2025-11-13","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 : 2025-11-13DOI: 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.
{"title":"Health-related quality of life and fear of recurrence after early breast cancer treatment: Results from a cross-sectional survey","authors":"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","doi":"10.1016/j.breast.2025.104647","DOIUrl":"10.1016/j.breast.2025.104647","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Results</h3><div>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.</div></div><div><h3>Conclusions</h3><div>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.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104647"},"PeriodicalIF":7.9,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145569974","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 : 2025-11-13DOI: 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
{"title":"Eligibility for bilateral prophylactic mastectomy: An expert opinion study in the Netherlands","authors":"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","doi":"10.1016/j.breast.2025.104645","DOIUrl":"10.1016/j.breast.2025.104645","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104645"},"PeriodicalIF":7.9,"publicationDate":"2025-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145569972","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 : 2025-11-12DOI: 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.
{"title":"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","authors":"Lesley Stephen , Janet Dunn , Claire Balmer , Nada Elbeltagi , Sophie Gasson , Ellen Copson , Carlo Palmieri","doi":"10.1016/j.breast.2025.104644","DOIUrl":"10.1016/j.breast.2025.104644","url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Findings</h3><div>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’.</div></div><div><h3>Interpretation</h3><div>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.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104644"},"PeriodicalIF":7.9,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145570208","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 : 2025-11-11DOI: 10.1016/j.breast.2025.104646
Xiaoyang Du , Leo Gkekos , Balram Rai , Anna L.V. Johansson , Irma Fredriksson , Mattias Rantalainen , Emelie Heintz , Shuang Hao , Mark Clements
Background
With new emerging technologies for diagnostics and treatment for breast cancer, there is a demand for updated breast cancer costs based on current clinical practice. The objectives of this study were to estimate recent societal costs of breast cancer in Sweden and provide population-based patient-level cost estimates for health economic evaluations.
Methods
This prevalence-based cost-of-illness study was based on 2019 data linking multiple Swedish national registers. The analysis employed a societal perspective considering direct health care, informal care, and productivity losses. Total costs were estimated using a bottom-up micro-costing approach. Direct costs per patient-year were also estimated by subgroups, including age group, breast cancer subtype, breast cancer stage at diagnosis, and disease state defined by metastatic status.
Findings
82,960 breast cancer patients diagnosed since 2008 were alive by the end of 2019. The annual societal cost of breast cancer in Sweden was €632 million, where the direct health care, informal care, and productivity losses accounted for 37 %, 5 %, and 57 %, respectively. The cost per capita was €61. Costs of direct health care, including inpatient/outpatient care and prescribed drugs, varied by subgroups, where younger age, higher stage, and more adverse subtypes were associated with higher costs per patient-year. Patients with a diagnosis of de novo metastatic cancer incurred the highest mean cost per patient-year.
Conclusion
Breast cancer represents a large economic burden in Sweden. The mean cost estimates per patient-year are informative to future health economic evaluations for breast cancer screening and treatment.
{"title":"Breaking down the costs for breast cancer: Insights from Sweden's national quality register","authors":"Xiaoyang Du , Leo Gkekos , Balram Rai , Anna L.V. Johansson , Irma Fredriksson , Mattias Rantalainen , Emelie Heintz , Shuang Hao , Mark Clements","doi":"10.1016/j.breast.2025.104646","DOIUrl":"10.1016/j.breast.2025.104646","url":null,"abstract":"<div><h3>Background</h3><div>With new emerging technologies for diagnostics and treatment for breast cancer, there is a demand for updated breast cancer costs based on current clinical practice. The objectives of this study were to estimate recent societal costs of breast cancer in Sweden and provide population-based patient-level cost estimates for health economic evaluations.</div></div><div><h3>Methods</h3><div>This prevalence-based cost-of-illness study was based on 2019 data linking multiple Swedish national registers. The analysis employed a societal perspective considering direct health care, informal care, and productivity losses. Total costs were estimated using a bottom-up micro-costing approach. Direct costs per patient-year were also estimated by subgroups, including age group, breast cancer subtype, breast cancer stage at diagnosis, and disease state defined by metastatic status.</div></div><div><h3>Findings</h3><div>82,960 breast cancer patients diagnosed since 2008 were alive by the end of 2019. The annual societal cost of breast cancer in Sweden was €632 million, where the direct health care, informal care, and productivity losses accounted for 37 %, 5 %, and 57 %, respectively. The cost per capita was €61. Costs of direct health care, including inpatient/outpatient care and prescribed drugs, varied by subgroups, where younger age, higher stage, and more adverse subtypes were associated with higher costs per patient-year. Patients with a diagnosis of de novo metastatic cancer incurred the highest mean cost per patient-year.</div></div><div><h3>Conclusion</h3><div>Breast cancer represents a large economic burden in Sweden. The mean cost estimates per patient-year are informative to future health economic evaluations for breast cancer screening and treatment.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"85 ","pages":"Article 104646"},"PeriodicalIF":7.9,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145518957","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":"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}
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