Breast Cancer Research and Treatment最新文献

{"title":"Is the risk of local recurrence higher for microinvasive breast cancer vs. early stage invasive breast cancer?","authors":"Camille Hardy Abeloos, Jason Gurewitz, Julie Xiao, Farbod Darvishian, Cheongeun Oh, Naamit Gerber","doi":"10.1007/s10549-025-07664-z","DOIUrl":"10.1007/s10549-025-07664-z","url":null,"abstract":"<p><strong>Purpose: </strong>The prognosis and optimal treatment for microinvasive breast cancer is controversial with some data indicating a higher local recurrence with microinvasive disease as compared to early-stage invasive breast cancer. The goal of our study was to compare long-term outcomes between patients with T1mi disease and early-stage breast cancer after breast-conserving surgery and whole breast irradiation (WBI).</p><p><strong>Methods: </strong>We reviewed all patients treated at our institution from 2013 to 2019 with T1mi-T2N0 disease. Cox proportional hazard model was used to find independent prognostic variables associated with local recurrence (LR). Survival curves were analyzed by Kaplan-Meier.</p><p><strong>Results: </strong>We found 1155 patients with 56 (4.8%) having T1mi disease. The 5-year local recurrence rate was 5.3% in patients with T1mi disease and 1.2% in patients T1-2 disease (HR = 2.73; 95% CI 0.43, 17.9; p = 0.09). On Cox multivariate analysis, younger age, positive margins and the need for re-excision were prognostic for LR. Out of the 3 patients with microinvasive disease who developed a local recurrence, two had DCIS < 2 mm from the margin and the third patient underwent two re-excisions due to DCIS margins < 2 mm.</p><p><strong>Conclusions: </strong>Our study showed that patients with microinvasive disease treated with hypofractionated WBI had a numerically higher 5-year local recurrence rate than patients with T1a-2 disease though this difference was not statistically significant. Given the rarity of microinvasive disease, further work is needed to define optimal surgical and adjuvant management and to better clarify the risk of local recurrence in this patient population.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"479-487"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Breast imaging recommendations for young females (age < 40 years) with ≥ 20% lifetime breast cancer risk: practice patterns at a specialized clinic.","authors":"Alexandra Wehbe, Fisher Katlin, Eshita Sharma, Marybeth Hans, Mary Knust Graichen, Brittany L Bychkovsky, Rochelle Scheib, Judy E Garber, Lydia E Pace, Tari A King, Alison Laws","doi":"10.1007/s10549-025-07738-y","DOIUrl":"https://doi.org/10.1007/s10549-025-07738-y","url":null,"abstract":"<p><strong>Purpose: </strong>The National Comprehensive Cancer Network (NCCN) and American Cancer Society (ACS) endorse differing guidelines for screening breast imaging among young females with familial breast cancer risk not driven by a germline pathogenic variant (PV). We sought to characterize practice patterns in our high-risk breast clinic related to screening breast imaging in this population.</p><p><strong>Methods: </strong>We identified all females aged 25-39 years with a first- or second-degree relative (FDR/SDR) with breast cancer and estimated lifetime breast cancer risk of ≥ 20% by the Tyrer-Cuzick (TC) version 7 model. Those with known PV in a breast cancer gene were excluded. We described provider recommendations for age to initiate screening and use of supplemental imaging modalities.</p><p><strong>Results: </strong>Among 334 included patients, 218 (65.3%) had an FDR with breast cancer and 116 (34.7%) had SDRs only. Screening prior to age 40 was recommended to 233 (69.8%) patients and varied by extent of family history and age of the youngest affected relative. Only a minority (24.1-27.0%) of recommendations aligned with NCCN or ACS guidelines. For the remaining patients, 82.2% and 48.7% were recommended to initiate screening younger than the NCCN or ACS guideline, respectively. Supplemental imaging with MRI or whole breast ultrasound was offered to 219 (65.6%) patients.</p><p><strong>Conclusion: </strong>Even in a specialized clinic, there is substantial variation in breast imaging recommendations for young females with elevated breast cancer risk based on family history. As formal risk assessment is increasingly adopted in clinical practice, this population should be a priority for future screening imaging studies.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with locoregional recurrence after neoadjuvant chemotherapy for breast cancer in a safety-net medical center.","authors":"Danielle Brabender, Deena Hossino, Sean Kim, Margaret Jayich, Lauren Polyakov, David Gomez, Azadeh A Carr, Stephen F Sener","doi":"10.1007/s10549-025-07668-9","DOIUrl":"10.1007/s10549-025-07668-9","url":null,"abstract":"<p><strong>Background: </strong>The management of locally advanced breast cancer poses significant challenges, with contemporary strategies involving an approach that combines systemic and local treatment. The current study was performed to validate the clinical impression that locoregional recurrences have become increasingly uncommon after standardized multimodal treatment protocol.Please check and confirm that the authors and their respective affiliations have been correctly identified and amend if necessary.All authors and affiliations are correct.</p><p><strong>Methods: </strong>A retrospective analysis was performed using a single-institution database that included clinical, radiographic, and pathologic parameters for all non-metastatic and non-inflammatory breast cancer patients treated with neoadjuvant chemotherapy (NAC) from 2015 to 2023. Uni- and multivariable analyses were performed to define associations between clinical factors, recurrence, and RFS.</p><p><strong>Results: </strong>The median age was 51 years for 274 predominantly Hispanic (78%) patients, with a median follow-up of 38.1 months. The recurrence rates were 4% local, 2% regional, and 18% distant. Median time from surgery to local recurrence was 8.2 months and to regional recurrence was 9.7 months. There were no locoregional clinical recurrences in 92 (34%) patients who had pCR or in 85 (31%) patients who had radiological complete response after NAC. Locoregional recurrences were uncommon > 12 months after surgery. Five of 11 local recurrences occurred in patients who had a poor response to NAC (ypT4b). All 6 patients having regional recurrences had adjuvant radiation therapy, and only 2 occurred in patients who were pathologically node-negative (ypN0) post-NAC.</p><p><strong>Conclusions: </strong>Favorable responses to NAC were associated with excellent locoregional control rates. Results achieved for predominantly Hispanic patients at a safety net medical center were similar to those reported in prospective, randomized clinical trials.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"517-526"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006201/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Postoperative radiotherapy improves long-term survival in HER2-positive metastatic breast cancer: real-world evidence from the latest SEER database.","authors":"Ling-Xiao Xie, Yang Liu, Yao-Guo Yang, Jing-Nan Wang, Yan-Qun Zhang, Tao Wang, Lu-Yang Bian, Hao Jiang, Xiao-Ming Su, Yong-Chun Zhou","doi":"10.1007/s10549-025-07665-y","DOIUrl":"10.1007/s10549-025-07665-y","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the role of Postoperative Radiotherapy (PORT) in HER2-positive metastatic breast cancer (MBC) in the context of targeted therapy and clarify the subgroups that may benefit from PORT.</p><p><strong>Methods: </strong>Clinical data of female patients with HER2-positive MBC from the surveillance, epidemiology, and end results (SEER) database for the years 2016-2020 were collected according to established inclusion and exclusion criteria. The impact of PORT on patient survival was assessed, and subgroup analyses were performed to identify populations with potential benefits from PORT.</p><p><strong>Results: </strong>A total of 541 patients from the SEER database were included in the analysis. The 3-year overall survival (OS) of the PORT group was significantly higher than that of the non-PORT group. (86.7% vs. 80.2%, P = 0.011). Multivariate analysis revealed that race and PORT were independent prognostic factors. Black patients and those who received PORT had longer overall survival (OS) (P < 0.05). Subgroup analysis suggested that PORT further improved OS in patients with mastectomy, advanced TN stage, high tumor grade, positive hormone receptor status, and multiple metastatic organs (P < 0.05).</p><p><strong>Conclusion: </strong>PORT further improves the survival of HER2-positive MBC. Subgroup analysis suggests that patients with locally advanced stage (T3-4, N2-3), Grade III, HR-positive status, bone-and-visceral metastasis, and those who have undergone mastectomy benefit significantly.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"489-500"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Body composition as a potential biomarker of recurrence risk in patients with triple-negative breast cancer.","authors":"Jill B De Vis, Cong Wang, Kirsten V Nguyen, Lili Sun, Brigitte Jia, Alexander D Sherry, Mason N Alford-Holloway, Meridith L Balbach, Tatsuki Koyama, A Bapsi Chakravarthy, Marjan Rafat","doi":"10.1007/s10549-025-07675-w","DOIUrl":"10.1007/s10549-025-07675-w","url":null,"abstract":"<p><strong>Background: </strong>Triple-negative breast cancer (TNBC) patients are at increased risk for recurrence compared to other subtypes of breast cancer. Previous evidence showed that adiposity may contribute to worsened cancer control. Current measures of obesity, such as body-mass index (BMI), are poor surrogates of adiposity, while visceral-to-subcutaneous adiposity ratio (VSR), which can be measured from routine computed tomography (CT) imaging, is a direct adiposity measure. We hypothesized that VSR is a stronger predictor of recurrence compared with BMI in patients with TNBC.</p><p><strong>Materials and methods: </strong>This study includes 162 women with stage I-III TNBC who completed standard of care therapy. Measures of body composition, including VSR, visceral adiposity (VA), and subcutaneous adiposity (SA), were estimated using a semi-automated quantitative imaging tool on CT images of the abdomen at the level of L2-L3. Anthropometric measures included BMI and waist circumference and were obtained from CT images. Associations of adiposity measures and recurrence risk were assessed using Fine and Gray competing risk models with death as a competing risk and age at diagnosis and clinical disease stage as covariates.</p><p><strong>Results: </strong>During a median follow-up time of 7.1 years, 55 patients had recurrence. The median BMI at baseline was 30.2 [Quartiles: 26.3-35.2]. Body composition was not associated with overall or locoregional recurrence. VSR was significantly associated with an increased risk of distant recurrence, with a subdistribution hazard ratio of 4.25 (95% CI: 1.06-17.02), p = 0.041. By contrast, BMI was not associated with any recurrence risk.</p><p><strong>Conclusion: </strong>Consistent with our hypothesis, VSR was associated with a significant risk of distant recurrence and therefore may be a prognostic biomarker. Future directions include interventions targeting VSR reduction among patients with TNBC and VSR-directed therapy modulation.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"627-635"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12031647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the impact of histological vs. nuclear grading on CPS + EG Score for HR + /HER2-early breast cancer.","authors":"M Braun, M Hamann, C Hanusch, A Andrulat, E Bensmann, M Pölcher, M Beer, E Huber","doi":"10.1007/s10549-025-07685-8","DOIUrl":"10.1007/s10549-025-07685-8","url":null,"abstract":"<p><strong>Purpose: </strong>The CPS + EG score, widely used for risk assessment in high-risk HR + /HER2-early breast cancer following neoadjuvant chemotherapy (NAC), integrates clinical and pathological staging, estrogen receptor status, and nuclear grading (nG). However, histological grading (hG) is often used in clinical practice due to better availability. This study aims to assess the concordance between nG and hG and examine their impact on CPS + EG scores.</p><p><strong>Methods: </strong>A retrospective analysis was conducted at the Red Cross Hospital Munich with two cohorts. Cohort 1 included 610 consecutively treated patients in 2022 to evaluate the concordance of nG and hG scores. Cohort 2 involved 106 high-risk patients treated between 2019 and 2022, comparing CPS + EG scores calculated using nG versus hG values.</p><p><strong>Results: </strong>In Cohort 1, nG and hG were discordant in 31.2% of cases, with nG3 classifications outnumbering hG3. Cohort 2 showed a similar discordance rate of 33.0%, with more tumors classified as nG3 (52.8%) than hG3 (36.8%). Among non-pCR patients, a CPS + EG score of ≥ 3 was found in 29.7% of cases with nG, versus 19.0% with hG, indicating hG may underestimate risk.</p><p><strong>Conclusion: </strong>Using hG instead of nG for CPS + EG calculations may underestimate risks related to distant metastasis-free and disease-specific survival, suggesting a potential need for nG prioritization in clinical risk assessments.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"699-704"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biology, care, and outcomes of gestational breast cancers: a review.","authors":"Niharika Duggirala, Shiliang Zhang, Aashini Master, Rashmi Rao, Nimmi S Kapoor, Aditya Bardia, Marla Lipsyc-Sharf","doi":"10.1007/s10549-025-07684-9","DOIUrl":"10.1007/s10549-025-07684-9","url":null,"abstract":"<p><strong>Purpose: </strong>The incidence of gestational breast cancers, breast cancers diagnosed during pregnancy, is increasing. There is a critical need to understand the pathophysiology, treatment recommendations, and remaining questions regarding care and therapeutics for this complex condition.</p><p><strong>Methods: </strong>Here, we review existing data regarding evaluation and management of gestational breast cancer, including safe imaging modalities, timing and choice of chemotherapy, evidence regarding targeted therapies during pregnancy. We highlight the importance of multidisciplinary care including oncologic, obstetric, and psychosocial care.</p><p><strong>Results: </strong>Gestational breast cancers are associated with unique biologic and clinicopathologic features that are impacted by physiologic changes of pregnancy such as upregulation of target genes associated with cell proliferation and immune regulation. Patients with gestational breast cancers more often present at advanced stages, are more likely to have aggressive tumor subtypes (i.e., triple negative or HER2 positive), and overall have worse prognoses than patients with non-gestational breast cancers. In this review, we synthesize recommendations for treatment strategies based on pregnancy trimester, optimal timing and choice of surgery, chemotherapy, targeted therapies, and psychosocial support.</p><p><strong>Conclusion: </strong>Developing a framework for clinical care and treatment of patients with gestational breast cancers is integral to improving outcomes for patients with gestational breast cancers. Optimal treatment includes collaborative management with a multidisciplinary team dedicated to both maternal and fetal care.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"547-559"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12031940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Goserelin 3-month depot shows non-inferiority to the monthly formulation in U.S. patients with premenopausal breast cancer: a real-world evidence study.","authors":"Kelly E McCann, Noran Osman, Joan Cannon, Lonnie Brent, Yuexi Wang, Jon Tepsick, Prithviraj Vikramsinh Mandora, Vincent Miller, Nancy Martin, Virginia G Kaklamani","doi":"10.1007/s10549-025-07656-z","DOIUrl":"10.1007/s10549-025-07656-z","url":null,"abstract":"<p><strong>Purpose: </strong>Clinical trials demonstrated every 3-month goserelin 10.8 mg to be non-inferior to monthly goserelin 3.6 mg in premenopausal patients with ER-positive breast cancer. However, real-world studies comparing 3-month goserelin 10.8 mg with monthly goserelin 3.6 mg are scarce.</p><p><strong>Methods: </strong>Electronic medical records from the ConcertAI Patient360™ database were analyzed in U.S. patients exposed to goserelin 3.6 mg or 10.8 mg post-breast cancer diagnosis. Inverse probability of treatment weighting (IPTW) was used to ensure the comparability between the two cohorts (goserelin 3.6 mg and goserelin 10.8 mg). The non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg was assessed by 12-month real-world event-free survival (rwEFS) rates (- 15% margin) for the overall group of patients and separately for patients with early-stage/locally advanced and metastatic breast cancer.</p><p><strong>Results: </strong>A total of 575 patients received goserelin 3.6 mg and 123 received goserelin 10.8 mg. Goserelin 10.8 mg was non-inferior to goserelin 3.6 mg based on observed 12-month rwEFS rates (79.2% versus 76.6%, respectively; treatment difference 2.7%). Goserelin 10.8 mg was observed to be non-inferior in patients who initiated goserelin in early-stage/locally advanced (treatment difference - 2.3%) and metastatic (treatment difference 10.4%) breast cancer.</p><p><strong>Conclusion: </strong>This real-world analysis indicates that 3-month goserelin 10.8 mg is non-inferior to monthly 3.6 mg among premenopausal women with breast cancer in terms of 12-month rwEFS rate. These findings may support the use of the 3-month goserelin 10.8 mg as an alternative treatment option to monthly goserelin 3.6 mg for this patient population.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"409-419"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006218/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143571699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A potential therapeutic molecule target: lncRNA AK023507 inhibits the metastasis of breast cancer by regulating the WNT/DOCK4/β-catenin axis.","authors":"Biyu Diao, Yangjun Cai, Dandan Song, Yingying Hu, Bojian Xie, Yang Kan, Xiaoqu Hu","doi":"10.1007/s10549-025-07695-6","DOIUrl":"https://doi.org/10.1007/s10549-025-07695-6","url":null,"abstract":"<p><strong>Purpose: </strong>Breast cancer (BC) has become the most common malignant tumor in women worldwide. This study was carried out to find and validate a novel molecular therapeutic target for BC.</p><p><strong>Methods: </strong>Long non-coding RNA (lncRNA) AK023507 was selected as the study objects through microarray analysis. The function of lncRNA AK023507 was verified by various cell function experiments in vitro, subcutaneous tumorigenesis experiments, and lung metastasis model experiments in vivo. The RNA pull-down experiment and Western blot experiment were used to confirm the mechanism regulation pathway and the recovery experiment was used to verify it. TCGA datasets were used for clinical and immune function prediction analysis.</p><p><strong>Results: </strong>In vitro cell function tests and in vivo experiments suggested that overexpression of lncRNA AK023507 inhibited the proliferation and metastasis of BC cells. The RNA pull-down experiment and Western blot analysis validated that lncRNA AK023507 interacted with the dedicator of cytokinesis 4 (DOCK4) protein. Analysis of public databases predicted that DOCK4 is a potential prognostic risk factor associated with epithelial-mesenchymal transition (EMT) and central memory T cell (TCM) cellular immune infiltration.</p><p><strong>Conclusions: </strong>LncRNA AK023507 inhibits the proliferation and metastasis of BC by regulating the DOCK4/β-catenin axis. This discovery will provide new potential therapeutic targets for BC.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"211 3","pages":"727-741"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk-guided cardioprotection with carvedilol in patients with breast cancer (CCT guide): a phase 1 randomized clinical trial.","authors":"Wonyoung Jung, Rebecca A Hubbard, Amanda M Smith, Kyunga Ko, Anran Huang, Jessica Wang, Jordan M Isaacs, Liyong Zhang, Peter P Liu, Zhen Chen, Payal D Shah, David Mintzer, Saveri Bhattacharya, Hayley M Knollman, Amy S Clark, Daniel Koropeckyj-Cox, Melissa Messinger, Nicholas S Wilcox, Congying Xia, Vivek Narayan, Jenica N Upshaw, Saro H Armenian, Bonnie Ky","doi":"10.1007/s10549-025-07636-3","DOIUrl":"10.1007/s10549-025-07636-3","url":null,"abstract":"<p><strong>Purpose: </strong>Breast cancer treatment results in increased cardiotoxicity risk; a risk-guided approach to cardioprotection has not been fully tested.</p><p><strong>Methods: </strong>This single-center, randomized Phase I trial enrolled patients with Stage I-III breast cancer who planned to receive anthracycline and/or trastuzumab therapy. An internally validated cardiotoxicity risk score classified participants as low or elevated risk. Elevated risk participants were randomized to receive open-label carvedilol or usual care for 12 months, beginning at cancer therapy initiation. Study visits occurred at baseline, 3, 6, 9, 12, and 24 months. Primary outcomes included feasibility, safety, and tolerability. Exploratory outcomes included echocardiography, biologic, and patient-reported measures.</p><p><strong>Results: </strong>Of the 166 eligible patients approached, 68 (41%) agreed to participate and ultimately enrolled. Among these participants (median age 52, 35% Black), 49 were classified as low and 19 elevated risk. Within the elevated risk group, 13 were randomized to carvedilol and 6 usual care. For those randomized to carvedilol, the median maximum dose was 6.25 mg twice daily, with 93% adherence. Adverse events of interest (grade 3 + bradycardia, hypotension, or fatigue) occurred in 9% with carvedilol, 13% in usual care, and 4% in low risk groups. One (1.5%) low risk participant experienced cardiac dysfunction. There were no substantial differences in secondary outcomes across groups. The participant withdrawal rate was 7%.</p><p><strong>Conclusions: </strong>This Phase 1 trial demonstrates that a risk-guided strategy can be applied to patients with active cancer. However, additional strategies are necessary to optimize the design and execution of non-treatment intervention trials in patients with active cancer.</p><p><strong>Trial registration: </strong>NCT04023110.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":" ","pages":"293-305"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12006281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762833","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}