Breast Cancer Research and Treatment最新文献

{"title":"Machine learning and cox model-based prediction of CDK4/6 inhibitor outcomes in HR+/HER2 - metastatic breast cancer: a multicenter real-world study.","authors":"Binliang Liu, Tao Wu, Sijuan Ding, Xuan Liu, Xiaochun Zeng, Ziru Liu, Kaili Lu, Jiantao She, Jun Chen, Heng Tian, Qin Tong, Ke Tang, Juan Yu, Jianguo Wang, Li Ding, Yan Li, Liping Peng, Qiang Zhou, Huichong Zhou, Tengfei Chao, Quchang Ouyang, Ning Xie","doi":"10.1007/s10549-026-08019-y","DOIUrl":"10.1007/s10549-026-08019-y","url":null,"abstract":"<p><strong>Background: </strong>Cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) are standard therapy for HR+/HER2 - metastatic breast cancer (MBC), yet treatment outcomes vary substantially and individualized prognostic tools based on real-world data remain limited. This study evaluated real-world effectiveness and developed prognostic models integrating Cox regression and machine learning.</p><p><strong>Methods: </strong>This multicenter retrospective study included 1,008 HR+/HER2 - MBC patients treated with CDK4/6is across 20 cancer centers in central China. Treatment patterns were analyzed in the overall cohort. PFS and prognostic factors were evaluated in patients receiving first- or second-line CDK4/6is using Kaplan-Meier and Cox regression analyses. These patients were randomly divided into training and validation cohorts (7:3). A Cox model and seven machine learning algorithms (GBM, RSF, Lasso-Cox, CoxBoost, XGBoost, SuperPC, and plsRcox) were developed and compared using time-dependent AUC, calibration, and decision curve analysis.</p><p><strong>Results: </strong>CDK4/6is were used as first- and second-line therapy in 65.68% and 24.60% of patients. Median PFS was significantly longer in first-line versus second-line treatment (38.0 vs. 18.8 months, P < 0.001). Independent prognostic factors included Luminal B subtype, liver metastasis, and second-line treatment, while HER2 IHC 1 + and longer disease-free interval were favorable predictors. The Cox model showed good discrimination (AUCs: 0.731, 0.719, and 0.704). Among machine learning models, GBM and RSF showed higher discrimination in the training cohort but only moderate performance in the validation cohort.</p><p><strong>Conclusion: </strong>CDK4/6is demonstrated substantial real-world effectiveness. Both Cox and machine learning models enabled individualized prognostic prediction. GBM and RSF showed relatively better predictive performance, but external validation is still required before clinical application.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 3","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148629396","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":"VEMORA: Vaginal Estrogen versus non-hormonal MOisturizer in women Receiving Aromatase inhibitors: a randomized, controlled trial.","authors":"Polly Niravath, Mothaffar Rimawi, Kai Sun, Hanh Mai, Akshjot Puri, Anuja Vyas, Julie Nangia, Alexys Brock, Claudette Foreman, Humaira Adnan, Marianne Shafer, Anushka Anand, Abyssania Moges, Ebtesam Al Najjar, Sunil Mathur, Danielle Antosh, Rachel High, Tarrik Zaid, Jenny Chang, Kent Osborne","doi":"10.1007/s10549-026-08025-0","DOIUrl":"10.1007/s10549-026-08025-0","url":null,"abstract":"<p><strong>Purpose: </strong>Genitourinary Syndrome of Menopause (GSM) remains a significant unmet need for postmenopausal breast cancer survivors receiving aromatase inhibitor (AI) therapy.</p><p><strong>Methods: </strong>In this randomized, controlled, open-label clinical trial, ER+ breast cancer survivors receiving adjuvant AI therapy with symptomatic GSM were randomized to receive 24 weeks of a non-hormonal vaginal moisturizer (Replens^®) or vaginal estrogen therapy (either Vagifem^® vaginal tablets or Estring^® vaginal ring). The primary endpoint was change in vaginal dryness. Secondary endpoints included dyspareunia, sexual functioning, vaginal pH, and serum estradiol values.</p><p><strong>Results: </strong>Twenty-three patients were enrolled (vaginal estrogen [VE], n = 11; non-hormonal [NH], n = 12). Vaginal dryness and dyspareunia scores improved significantly in the VE arm compared with the NH arm (p = 0.049, p = 0.048, respectively). Vaginal pH decreased significantly with vaginal estrogen compared to non-hormonal therapy (p = 0.0286). Other domains of sexual function (libido, ability to achieve orgasm, sexual satisfaction, and relationship with partner) were not significantly different between the 2 groups. Serum estradiol levels remained low through the first 12 weeks of therapy. Two participants demonstrated estradiol elevations above threshold at 24 weeks (21.8 pg/mL and 16 pg/mL); both reported non-adherence to AI therapy preceding measurement.</p><p><strong>Conclusion: </strong>In this randomized study, vaginal estrogen provided greater improvement in vaginal dryness and dyspareunia than non-hormonal therapy in breast cancer survivors. These findings provide prospective evidence supporting symptomatic benefit with minimal systemic estrogen exposure in most patients, although larger studies with longer follow up are needed to define long-term safety and efficacy.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618401","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":"Association between self-reported breast cancer knowledge and clinical trial participation in patients with triple-negative breast cancer.","authors":"Megan E Tesch, Noah Graham, Craig Snow, Catherine E Stever, Tonia S Parker, Melinda Luo, Isabella G Martino, Bridget Drummey, Sarina Virani, Katheryn Santos, Jad Bsat, Sean Ryan, Melissa E Hughes, Eileen Wrabel, Nadine Tung, Steve Lo, Nisar Ahmad, Meredith Faggen, Natalie Sinclair, Maria Constantinou, Sarah Sinclair, Jane L Meisel, Tari A King, Elizabeth A Mittendorf, Nabihah Tayob, Nancy U Lin, Ann H Partridge, Eric P Winer, Sara M Tolaney, Ana C Garrido-Castro","doi":"10.1007/s10549-026-08039-8","DOIUrl":"10.1007/s10549-026-08039-8","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with triple-negative breast cancer (TNBC) are encouraged to consider clinical trials given limited treatment options, yet little is known regarding barriers to trial participation in this population. We examined whether patient-level factors, including disease knowledge, were associated with TNBC patients' participation in trials.</p><p><strong>Methods: </strong>From a prospective multicenter registry of patients with newly-diagnosed TNBC, we identified those with stage I-III tumors who completed at least one survey assessing TNBC knowledge, risk perceptions, treatment rationales, and participation in trials. Accuracy of tumor characteristics reported by patients was verified with medical records. Logistic regression was used to identify factors associated with self-reported trial participation.</p><p><strong>Results: </strong>TNBC knowledge varied among patients, with many reporting their tumor characteristics incorrectly and/or underestimating their recurrence risk. Among 116 patients with trial participation responses, 55 (47%) reported participating in a trial, including 35% who underwent upfront surgery and 66% who received neoadjuvant systemic therapy. Trial participation was less likely in upfront surgery patients (odds ratio [OR]: 0.41, 95% confidence interval [CI]: 0.20-0.89, p = 0.02) and more likely in stage II versus stage I patients (OR: 2.43, 95% CI: 1.09-5.39; p = 0.03). No associations were found with TNBC knowledge.</p><p><strong>Conclusion: </strong>Nearly half of patients surveyed reported participating in trials. While not significantly associated with trial participation, many patients demonstrated limited knowledge about TNBC and their prognosis. More research is needed to understand trial participation barriers and improve information delivery in this population to leverage patient engagement in developing more effective TNBC treatments.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148617976","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":"Correction: Correlation between the drainage time in dynamic indocyanine green lymphography (ICG) and axillary lymph nodes metastatic involvement in breast cancer patients-a prospective study.","authors":"Karolina Anuszkiewicz, Marcin Ekman, Magdalena Graczyk, Mateusz Drozd, Kamil Drucis, Jerzy Jankau","doi":"10.1007/s10549-026-08010-7","DOIUrl":"10.1007/s10549-026-08010-7","url":null,"abstract":"","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618093","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":"Assisted Reproductive Technologies (ART) and breast cancer risk: hormonal treatments under the spotlight.","authors":"Cristiana Boldrini, Micol Bottalico, Francesca L Lia, Valentina Longo, Silvia Gigli","doi":"10.1007/s10549-026-08036-x","DOIUrl":"10.1007/s10549-026-08036-x","url":null,"abstract":"<p><strong>Background: </strong>Assisted Reproductive Technologies (ART) have become nowadays a cornerstone in the management of infertility. While these treatments are generally considered safe, concerns have been raised regarding their potential influence on breast cancer (BC) risk, particularly in specific subgroups of women.</p><p><strong>Objective: </strong>This narrative review aims to evaluate the most relevant past and current literature on the association between ART-related hormonal treatments and breast cancer risk, highlighting potential biological mechanisms, epidemiological evidence, and clinical implications.</p><p><strong>Methods: </strong>A literature search was conducted through PubMed, focusing on medium-to-large cohort and case-control studies, meta-analyses, and guidelines published to date. Evidence was synthesized by distinguishing overall ART/IVF risk estimates from drug-specific findings and subgroup-specific risk modifiers. Particular attention was given to the most recent or most comprehensive reports when multiple publications were derived from the same cohort.</p><p><strong>Results: </strong>To date, current evidence does not support a real and consistent overall increase in breast cancer risk following ART-related hormonal treatments. Large population-based studies and recent meta-analyses are generally reassuring, particularly when ART-treated women are compared with infertile untreated women rather than with the general population. Some studies report modest risk elevations in selected subgroups, including nulliparous or nulligravid women, women undergoing repeated or high-dose stimulation cycles, and women with hereditary BC predisposition; however, these findings are inconsistent and often limited by residual confounding, small subgroup numbers, and incomplete dose information. Progesterone supplementation appears safe in the context of ART, with no consistent evidence of increased BC risk. Gonadotropins, including hMG, may transiently increase estrogen exposure, but large-scale studies and meta-analyses generally do not confirm a long-term increase in breast cancer incidence.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13421214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618005","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":"Healthcare professional perspectives on hereditary breast cancer risk assessment prior to gender-affirming mastectomy.","authors":"Kimberly Zayhowski, Kai Blumen, Kathleen F Mittendorf, Rebekah Pratt, Tala Berro, Carl Streed, Ian M MacFarlane","doi":"10.1007/s10549-026-08038-9","DOIUrl":"10.1007/s10549-026-08038-9","url":null,"abstract":"<p><strong>Purpose: </strong>Transgender and gender diverse (TGD) individuals undergoing gender-affirming mastectomy (GAM) face unique challenges related to breast cancer risk assessment and screening. This study aimed to identify factors that influence healthcare professionals' (HCPs) integration of cancer risk evaluation, including genetic assessment, within the context of GAM and pre-surgical planning.</p><p><strong>Methods: </strong>We conducted semi-structured qualitative interviews with 20 healthcare professionals - including six primary care providers, five cancer genetic counselors, six oncologists, and three plastic surgeons - experienced in caring for TGD patients considering or undergoing GAM. Using a social constructivist framework, we applied reflexive thematic analysis to explore HCP perspectives and generate key themes.</p><p><strong>Results: </strong>We conceptualized five key themes: (1) HCPs perceive no clear ownership for care integration of breast cancer risk assessment; (2) conflicting guidelines force HCPs to rely on their own judgment, resulting in inconsistent practice; (3) care pathways are driven by individual HCP champions rather than standardized protocols; (4) GAM frequently occurs at young ages prior to age of population cancer risk screening initiation, complicating risk discussions; and (5) structural failures in care delivery compromise patient safety.</p><p><strong>Conclusion: </strong>Improving cancer risk assessment for TGD patients undergoing GAM demands clear institutional accountability, harmonized evidence-based guidelines, standardized care pathways, and genetic counseling embedded into multidisciplinary gender-affirming care teams. These coordinated structural efforts are critical to integrate equitable, personalized, and patient-centered cancer prevention with gender-affirming surgical care.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13421360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618134","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":"Clinical and imaging factors associated with prolonged ablation time in radiofrequency ablation for early-stage breast cancer.","authors":"Chika Watanabe, Shinichiro Kashiwagi, Mariko Nishikawa, Asuka Kochi, Koji Takada, Yukie Tauchi, Kana Ogisawa, Haruhito Kinoshita, Masatsune Shibutani, Tamami Morisaki","doi":"10.1007/s10549-026-08042-z","DOIUrl":"10.1007/s10549-026-08042-z","url":null,"abstract":"<p><strong>Purpose: </strong>Radiofrequency ablation (RFA) is a minimally invasive treatment for selected patients with early-stage breast cancer, but ablation time varies substantially. We investigated clinical, imaging, procedural, and pathological factors associated with prolonged ablation time.</p><p><strong>Methods: </strong>We retrospectively analyzed 72 patients who underwent breast RFA at a single institution between April 2024 and November 2025. Clinical variables, ultrasonographic tumor characteristics, mammography-based background breast density, ultrasonography-based puncture-site breast density, initial impedance, maximum power, and temperature were evaluated. Exploratory pathological assessment of stromal predominance was performed in 48 patients.</p><p><strong>Results: </strong>The median ablation time was 649.5 s (IQR 508.8-879.5). Ablation target size, ultrasonographic tumor dimensions, background density, puncture-site density (p < 0.001), and maximum power were positively associated with ablation time, whereas initial impedance showed a negative correlation. Puncture-site density and initial impedance were strongly inversely correlated (r = -0.716, p < 0.001). Mammography-based background density and ultrasonography-based puncture-site density showed substantial agreement (60/72, 83.3%) and strong ordinal correlation (Spearman r = 0.838, p < 0.001). In multivariable analysis, ablation target size (β = 60.26 s/mm, p = 0.003), initial impedance conditional on puncture-site density (β = 2.89 s/Ω, p = 0.015), and puncture-site density (β = 388.33 s/category, p < 0.001) were independently associated with prolonged ablation time.</p><p><strong>Conclusion: </strong>Ablation time is influenced by tumor size, local tissue density, impedance, and possibly stromal predominance. Local ultrasonographic assessment complements mammographic density for procedure-specific RFA planning, although prospective validation is required.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599118","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":"Antacid co-treatment and pregnane X receptor genetic polymorphisms are survival determinants in patients treated with palbociclib.","authors":"Fanny Leenhardt, William Jacot, Lionel Lellouche, Severine Guiu, Marie Viala, Nelly Firmin, Alexandre Payen, Litaty C Mbatchi, Frederic Fiteni, Alexandre Evrard","doi":"10.1007/s10549-026-08041-0","DOIUrl":"10.1007/s10549-026-08041-0","url":null,"abstract":"<p><strong>Background: </strong>Palbociclib is the more extensively evaluated CDK4-6 inhibitor in term of safety, efficacy and sources of pharmacokinetic variability. However, real-life data on the correlation between palbociclib plasma concentration, drug-drug interactions, gene polymorphisms and efficacy remain scarce. We previously characterized the effects of co-medications (CYP3A4 and P-glycoprotein inhibitors and antacid drugs) on palbociclib plasma concentration, and here we wanted to identify factors that influence progression-free survival in the same cohort of patients.</p><p><strong>Methods: </strong>This multicentric prospective clinical trial included patients with metastatic breast cancer treated with first-line palbociclib and an aromatase inhibitor. Efficacy (progression-free survival) and safety (high-grade neutropenia during the first two cycles) were reported, and the influence of covariates, such as drug-drug interactions, palbociclib plasma concentration and specific gene variants, were analyzed.</p><p><strong>Results: </strong>In the 58 included patients, drug-drug interactions (antacid drugs) and pregnane X receptor (NR1I2) single nucleotide polymorphisms (SNP) were identified as survival prognostic factors, but not palbociclib concentration and high-grade neutropenia (p = 0.4 and p = 0.5). Concomitant antacid treatment reduced progression-free survival (26.2 vs. 32.6 months, p = 0.059) and the NR1I2 rs10934498 and rs2276707 SNPs affected survival (p = 0.002 and 0.004).</p><p><strong>Conclusion: </strong>This study consolidated the data on palbociclib as first-line metastatic breast cancer treatment and identified factors that negatively influence survival (co-treatment with antacid drugs and NR1I2 SNPs).</p><p><strong>Trial registration: </strong>NCT04025541, Registration Date 2019-07-16.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148599174","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":"Age-dependent relative and absolute benefit of radiotherapy after breast-conserving surgery: a population-based analysis using SEER data.","authors":"Seiichi Imanishi, Namiko Tanaka, Chisato Takeuchi, Nobuyoshi Kittaka","doi":"10.1007/s10549-026-08034-z","DOIUrl":"10.1007/s10549-026-08034-z","url":null,"abstract":"<p><strong>Background: </strong>Radiotherapy (RT) after breast-conserving surgery (BCS) improves breast cancer outcomes. However, its clinical relevance may vary with age, particularly in the presence of competing risks and treatment burden. How the association between RT and breast cancer-specific survival changes across the age spectrum has not been well characterized.</p><p><strong>Methods: </strong>Patients aged ≥ 50 years who underwent BCS for breast cancer were identified from the SEER database between 2000 and 2022. Patients with unknown or refused RT status, unknown cause of death, or follow-up < 3 months were excluded. Inverse probability of treatment weighting (IPTW)-adjusted Cox proportional hazards models with age-by-treatment interaction terms were used to estimate age-specific associations between RT and breast cancer-specific survival (BCSS). Absolute effects were assessed using cumulative incidence functions accounting for competing risks, and continuous age effects were evaluated using restricted cubic spline models.</p><p><strong>Results: </strong>Among 532,118 eligible patients, 409,652 (77.0%) received RT and 122,466 (23.0%) did not. RT was associated with improved BCSS across all age groups. The relative association attenuated with increasing age, with hazard ratios increasing from 0.54 (95% CI, 0.51-0.58) among patients aged 50-54 years to 0.81 (95% CI, 0.75-0.88) among those aged ≥ 85 years (p for interaction < 0.001). Absolute risk reduction also decreased with age, from approximately 5.2-5.6% in younger patients to 2.9-3.7% in patients aged 70-84 years. Restricted cubic spline analysis showed a gradual attenuation of the RT-associated survival advantage with age, without evidence of an abrupt threshold.</p><p><strong>Conclusions: </strong>RT after BCS was associated with improved BCSS across the age spectrum, although both relative and absolute benefits became smaller with increasing age. These findings support individualized treatment decisions that consider absolute benefit, competing risks, and patient-specific factors rather than relying only on fixed age thresholds.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148577120","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":"Abemaciclib rechallenge after progression on abemaciclib plus endocrine therapy in patients with hormone receptor-positive HER2-negative metastatic breast cancer: results from the phase II again study (WJOG14220B).","authors":"Meiko Nishimura, Takahiro Kogawa, Keiji Sugiyama, Yukinori Ozaki, Yuko Tanabe, Chikako Funasaka, Sasagu Kurozumi, Akiyo Yoshimura, Tsutomu Iwasa, Hitomi Sakai, Mitsunori Morita, Satomi Watanabe, Takaaki Fujii, Mitsugu Yamamoto, Yasushi Tsuji, Mitsuo Terada, Takayo Ota, Shinya Tokunaga, Mototsugu Shimokawa, Toshimi Takano","doi":"10.1007/s10549-026-08031-2","DOIUrl":"10.1007/s10549-026-08031-2","url":null,"abstract":"<p><strong>Purpose: </strong>In the postMONARCH trial, abemaciclib plus fulvestrant (FUL) yielded a progression-free survival (PFS) of 6.0 months in hormone receptor (HR)-positive HER2-negative metastatic breast cancer patients who progressed after receiving CDK4/6 inhibitor plus endocrine therapy (ET). However, only 8% of these patients had previously received abemaciclib.</p><p><strong>Methods: </strong>This multicenter, single-arm, phase II study enrolled patients who developed disease progression after abemaciclib plus ET. Patients were switched from aromatase inhibitor (AI)/tamoxifen (TAM) to FUL or from FUL to AI while continuing abemaciclib. The primary endpoint was PFS. The secondary endpoints were the overall response rate (ORR), clinical benefit rate (CBR), chemotherapy-free interval (CFI), overall survival (OS), and safety. Biomarker analysis was performed based on gene alterations.</p><p><strong>Results: </strong>This study enrolled 65 patients from June 2021 to November 2023; 64 patients could be evaluated following 1 withdrawal. The median PFS for the 64 patients was 4.2 months (90% CI, 2.8-4.4). The median PFS was 7.1 months (95% CI, 3.9-11.3) in patients who switched from abemaciclib plus AI/TAM to abemaciclib plus FUL (n = 28, 43.8%), whereas it was 2.8 months (95% CI, 1.9-4.2) in patients switching from abemaciclib plus FUL to abemaciclib plus AI (n = 36, 56.3%). The ORR was 8.7% (95% CI, 2.4-20.8), the CBR was 23.9% (95% CI, 12.6-38.8), the CFI was 6.7 months (95% CI, 4.9-11.0), and the OS was 28.7 months (95% CI, 25.4-not estimable [NE]).</p><p><strong>Conclusions: </strong>The primary endpoint was not met; switching from abemaciclib plus AI/TAM to abemaciclib plus FUL may be a clinically effective option. JRCTS031210129: Date of registration JUNE 2, 2021.</p>","PeriodicalId":9133,"journal":{"name":"Breast Cancer Research and Treatment","volume":"218 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2026-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13385166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148519887","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}