Omission of sentinel lymph node biopsy in patients with clinically axillary lymph node-negative early breast cancer (OMSLNB): protocol for a prospective, non-inferiority, single-arm, phase II clinical trial in China.

INTRODUCTION: Sentinel lymph node biopsy (SLNB) is a standard procedure for patients with clinically assessed negative axillary lymph nodes (cN0) during early-stage breast cancer (EBC). However, the majority of EBC patients have a negative pathological confirmation of the sentinel lymph node (SLN), and axillary surgery is inevitably associated with postoperative complications. Considering that SLNB has no therapeutic benefit, this trial aims to determine the safety of omitting SLNB in patients with cN0 early invasive breast cancer. METHODS AND ANALYSIS: The OMSLNB trial is a prospective, single-arm, non-inferiority, phase II, open-label study design involving female breast cancer patients with a tumor of ≤3 cm in diameter, who are considered axillary lymph-node-negative based on two or more radiological examinations, including axillary lymph node ultrasonography. Eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery. The trial begins in 2023 and is scheduled to end in 2027. The primary endpoint is 3 year invasive disease-free survival (iDFS). The secondary endpoints include the incidence of breast cancer-related lymphoedema, patient-reported outcomes, locoregional recurrence, local recurrence and regional recurrence. It is expected that the 3 year iDFS in patients undergoing SLNB is about 90%, combined with a non-inferiority cut-off of 5%, 80% power, 95% CIs, 0.05 test level, and 10% loss to follow-up rate, the planned enrollment is 311 patients. All enrolled patients will be included in the intention-to-treat analysis. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (No.2023-SR-193). All participants must provide written informed consent to be eligible. The protocol will be described in a peer-reviewed manuscript, and the results will be published in scientific journals and/or at academic conferences. TRIAL REGISTRATION NUMBER: NCT05935150.

Patient journey and timeliness of care for patients with breast cancer in Africa: a scoping review protocol.

INTRODUCTION: Cancer is the leading cause of death worldwide, with breast cancer being one of the most commonly diagnosed types. Low-income and middle-income countries account for nearly half of all breast cancer cases and related fatalities. In Africa, mortality rates are higher and survival rates are lower compared with developed countries. Timeliness of care is a critical aspect of healthcare, but various studies and healthcare systems use different criteria and methods to measure it. Assessing the breast cancer care pathway and understanding the determinants of delayed care are essential for effective interventions. Therefore, this scoping review aims to evaluate the methods used to measure the timeliness of breast cancer care, identify specific points in the care pathway where delays are most frequently reported, and examine the factors affecting the timeliness of breast cancer care in Africa. METHODS AND ANALYSIS: We will conduct this scoping review using the Arksey and O'Malley framework endorsed by the Joanna Briggs Institute. A scoping review of articles written in English concerning the timeliness of breast cancer care in the African context will be undertaken. Six electronic databases (MEDLINE, EMBASE, CINAHL, SCOPUS, WEB Of SCIENCE and PsycINFO) will be searched to identify published literature on timeliness of breast care in Africa. Two reviewers will independently screen the articles at both the abstract and full-text stages, guided by predetermined inclusion and exclusion criteria. The full texts of identified studies will be further examined and charted using a data extraction form guided by the Model of Pathways to Treatment framework. Publications describing the time to diagnosis and its associated factors in the contexts of breast cancer will be considered for inclusion, with no restrictions based on date of publication. Studies that are published in languages other than English and that do not focus on the timeliness of care or time-related aspects within the care pathway will be excluded. Evidence will be narratively synthesised and analysed. ETHICS AND DISSEMINATION: Ethical approval is not needed as this scoping review does not involve collecting data from human participants. The results produced from this review will be submitted to a scientific peer-reviewed journal for publication and will be presented at scientific meetings.

Meta-analysis and systematic review of the diagnostic value of contrast-enhanced spectral mammography for the detection of breast cancer.

OBJECTIVE: The objective is to evaluate the diagnostic effectiveness of contrast-enhanced spectral mammography (CESM) in the diagnosis of breast cancer. DESIGN: DATA SOURCES: PubMed, Embase and Cochrane libraries up to 18 June 2022. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included trials studies, compared the results of different researchers on CESM in the diagnosis of breast cancer, and calculated the diagnostic value of CESM for breast cancer. DATA EXTRACTION AND SYNTHESIS: Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) evaluated the methodological quality of all the included studies. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses specification. In addition to sensitivity and specificity, other important parameters were explored in an analysis of CESM accuracy for breast cancer diagnosis. For overall accuracy estimation, summary receiver operating characteristic curves were calculated. STATA V.14.0 was used for all analyses. RESULTS: This meta-analysis included a total of 12 studies. According to the summary estimates for CESM in the diagnosis of breast cancer, the pooled sensitivity and specificity were 0.97 (95% CI 0.92 to 0.98) and 0.76 (95% CI 0.64 to 0.85), respectively. Positive likelihood ratio was 4.03 (95% CI 2.65 to 6.11), negative likelihood ratio was 0.05 (95% CI 0.02 to 0.09) and the diagnostic odds ratio was 89.49 (95% CI 45.78 to 174.92). Moreover, there was a 0.95 area under the curve. CONCLUSIONS: The CESM has high sensitivity and good specificity when it comes to evaluating breast cancer, particularly in women with dense breasts. Thus, provide more information for clinical diagnosis and treatment.

Shear-Wave Elastography Gradient Analysis of Newly Diagnosed Breast Tumours: A Critical Analysis.

BACKGROUND: A better understanding of the peritumoral stroma changes due to tumour invasion using non-invasive diagnostic methods may improve the differentiation between benign and malignant breast lesions. This study aimed to assess the correlation between breast lesion differentiation and intra- and peritumoral shear-wave elastography (SWE) gradients. METHODS: A total of 135 patients with newly diagnosed breast lesions were included. Intratumoral, subsurface, and three consecutive peritumoral SWE value measurements (with three repetitions) were performed. Intratumoral, interface, and peritumoral gradients (Gradient 1 and Gradient 2) were calculated using averaged SWE values. Statistical analysis included descriptive statistics and an ordinary one-way ANOVA to compare overall and individual gradients among Breast Imaging-Reporting and Data System (BI-RADS) 2, 3, and 5 groups. RESULTS: Malignant tumours showed higher average SWE velocity values at the tumour centre (BI-RADS 2/3: 4.1 ± 1.8 m/s vs. BI-RADS 5: 4.9 ± 2.0 m/s, p = 0.04) and the first peritumoral area (BI-RADS 2/3: 3.4 ± 1.8 m/s vs. BI-RADS 5: 4.3 ± 1.8 m/s, p = 0.003). No significant difference was found between intratumoral gradients (0.03 ± 0.32 m/s vs. 0.0 ± 0.28 m/s; p > 0.999) or gradients across the tumour-tissue interface (-0.17 ± 0.18 m/s vs. -0.13 ± 0.35 m/s; p = 0.202). However, the first peritumoral gradient (-0.16 ± 0.24 m/s vs. -0.35 ± 0.31 m/s; p < 0.0001) and the second peritumoral gradient (-0.11 ± 0.18 m/s vs. -0.22 ± 0.28 m/s; p = 0.037) were significantly steeper in malignant tumours. The AUC was best for PTG1 (0.7358) and PTG2 (0.7039). A threshold value for peritumoral SWI PT1 above 3.76 m/s and for PTG1 below -0.238 m/s·mm-1 indicated malignancy in 90.6% of cases. CONCLUSIONS: Evaluating the peritumoral SWE gradient may improve the diagnostic pre-test probability, as malignant tumours showed a significantly steeper curve of the elasticity values in the peritumoral stroma compared to the linear regression with a relatively flat curve of benign lesions.

Using polygenic risk modification to improve breast cancer prevention: study protocol for the PRiMo multicentre randomised controlled trial.

INTRODUCTION: Established personal and familial risk factors contribute collectively to a woman's risk of breast or ovarian cancer. Existing clinical services offer genetic testing for pathogenic variants in high-risk genes to investigate these risks but recent information on the role of common genomic variants, in the form of a Polygenic Risk Score (PRS), has provided the potential to further personalise breast and ovarian cancer risk assessment. Data from cohort studies support the potential of an integrated risk assessment to improve targeted risk management but experience of this approach in clinical practice is limited. METHODS AND ANALYSIS: The polygenic risk modification trial is an Australian multicentre prospective randomised controlled trial of integrated risk assessment including personal and family risk factors with inclusion of breast and ovarian PRS vs standard care. The study will enrol women, unaffected by cancer, undergoing predictive testing at a familial cancer clinic for a pathogenic variant in a known breast cancer (BC) or ovarian cancer (OC) predisposition gene (BRCA1, BRCA2, PALB2, CHEK2, ATM, RAD51C, RAD51D). Array-based genotyping will be used to generate breast cancer (313 SNP) and ovarian cancer (36 SNP) PRS. A suite of materials has been developed for the trial including an online portal for patient consent and questionnaires, and a clinician education programme to train healthcare providers in the use of integrated risk assessment. Long-term follow-up will evaluate differences in the assessed risk and management advice, patient risk management intentions and adherence, patient-reported experience and outcomes, and the health service implications of personalised risk assessment. ETHICS AND DISSEMINATION: This study has been approved by the Human Research Ethics Committee of Peter MacCallum Cancer Centre and at all participating centres. Study findings will be disseminated via peer-reviewed publications and conference presentations, and directly to participants. TRIAL REGISTRATION NUMBER: ACTRN12621000009819.

Comparative effect of different mindfulness-based intervention types and deliveries on depression in patients with breast cancer: a protocol for a systematic review and network meta-analysis.

INTRODUCTION: Breast cancer has become the most common cancer worldwide. Various types of mindfulness-based interventions (e.g., mindfulness-based cognitive therapy, mindfulness-based stress reduction) have been conducted in different delivery methods (including face to face and internet delivered) to help patients with breast cancer mitigate their depression. However, at present, there are no studies that compare the effectiveness of all these types and deliveries of mindfulness-based interventions. Therefore, this protocol aims to conduct a systematic review and network meta-analysis to assess the effectiveness of various types and deliveries of mindfulness-based interventions in mitigating depression in patients with breast cancer. METHODS: This protocol is according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The electronic databases, including PubMed, Web of Science, the Cochrane Library, Embase, Google Scholar, The China National Knowledge Infrastructure and OpenGrey, will be comprehensively retrieved for related randomised controlled trials (RCTs) from inception to December 2023. Two reviewers will independently assess the risk of bias using the Cochrane Risk of Bias Tool for Randomised Trials 2.0 (RoB 2.0). The network meta-analysis will be performed using the STATA V.16.0, and the assessment of heterogeneity, inconsistency, publication bias, evidence quality, subgroup analyses and sensitivity analyses will be conducted. ETHICS AND DISSEMINATION: This protocol does not require approval from an ethics committee as it is based on previous research findings. The results will be disseminated via peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42024495996.

Risk perception regarding social determinants of health among women with breast cancer in Iran: a qualitative study.

OBJECTIVES: Breast cancer is the most common cancer among women all around the world. Today, in addition to factors including hormones and genetics that are involved in the occurrence of breast cancer, special attention is paid to the role of social and non-medical determinants of health. This study aims to explore the perception of Social Determinants of Health (SDH) in women with breast cancer. DESIGN: Qualitative study design with a conventional thematic analysis approach. SETTING: The study was conducted in Tehran, Iran, between December 2021 and February 2023. PARTICIPANTS: 19 women with breast cancer were selected through purposeful and snowball sampling with maximum variation. Sampling continued until data saturation was reached. PRIMARY AND SECONDARY OUTCOME MEASURES: The study categorised the extracted codes from interviews into three main categories and 12 subcategories related to SDH in women with breast cancer. RESULTS: The study identified factors such as personal and family health records, health behaviours and lifestyles and medical screening and follow-up as key themes in the perception of SDH among women with breast cancer. The main categories were also categorised into 12 subcategories, 'including family history', 'environmental factors', 'hormonal and medicinal changes', 'metaphysical factors', 'traditional medicine-related factors', 'stress', 'body weight', 'physical activity', 'nutrition', 'smoking and tobacco use', 'screening', 'self-examination' and 'barriers to medical follow-up'. 'Near the telecommunications tower', 'Improper use of supplements', 'Being subjected to the evil eye regularly', 'Eating cold nature foods', 'Breast weight' and 'Being ashamed of the doctor' were some examples of the codes. CONCLUSIONS: Participants identified a number of environmental, personal and cultural factors as contributing to the disease. Woman's screening behaviours were influenced by factors such as fear of disease and death, disbelief in getting sick and shame, depending on cultural context. The study suggests the need for further research to explore the impact of these factors on screening behaviours and outcomes in different cultural contexts.

Breast cancer research gaps: a questionnaire-based study to determine overall priorities and compare the priorities of patients, the public, clinicians and scientists.

OBJECTIVE: This study aims to prioritise the themes identified from the three gap analyses performed by a combination of scientists, clinicians, patients and members of the public to determine areas in breast cancer care where research is lacking. We also aimed to compare the priorities of areas of agreed research need between patients, the public, clinicians and scientists. DESIGN: A cross-section of patients, public, clinicians and scientists completed a prioritisation exercise to rank the identified themes where research is lacking in breast cancer care. PARTICIPANTS: Patients, clinicians and scientists who have experienced, managed or worked in the field of breast cancer and members of the public. METHODS: The research areas identified in the Breast Cancer Campaign, Association of Breast Surgery and North West Breast Research Collaborative gap analyses were outlined as 22 themes in lay terminology. Patients, members of the public, clinicians and scientists were invited to complete the prioritisation exercise, on paper or electronically, ranking the themes from 1 to 22. Comparisons were made with arithmetic mean ranking. RESULTS: Of the 510 prioritisation exercises completed, 179 (35%) participants were patients, 162 (32%) public, 43 (8%) scientists and 122 (24%) clinicians. The theme ranked of highest priority overall was 'better prevention' (arithmetic mean rank 6.4 (SE 0.23)). 'Better prevention' was ranked top or second by patients, public and clinicians (7 (0.39), 4.7 (0.34) and 6.8 (0.5), respectively), however, scientists ranked this as their sixth most important factor (7.7 (0.92)). The public and clinicians had good agreement with patients (r=0.84 and r=0.75, respectively), whereas scientists had moderate agreement with patients (r=0.65). Certain themes were ranked significantly differently by participant groups. Compared with clinicians, patients prioritised research into 'alternative to mammograms', 'diagnostic (cancer) blood test' and 'rare cancers' (OR 2.1 (95% CI 1.3 to 3.5), p=0.002, OR 2.1 (95% CI 1.3 to 3.5), p=0.004 and OR 1.7 (95% CI 1.1 to 2.8), p=0.03). Compared with scientists, patients deprioritised 'better laboratory models' (OR 0.4 (95% CI 0.2 to 0.8), p=0.01). CONCLUSION: This study demonstrates that patients, public, clinicians and scientists have different research priorities, with scientists being a particular outlier. This highlights the need to ensure the engagement of patients and public in research funding prioritisation decisions.

Comparing long-term prognosis following different surgical methods in patients with early stage breast cancer and obesity: a retrospective cohort study in China.

OBJECTIVE: Breast-conserving therapy (BCT) includes breast-conserving surgery (BCS) combined with radiation therapy (RT). RT plays a crucial role in improving the prognosis of patients who undergo BCS. However, obesity is a potential risk factor for resistance to radiation. The aim of this study was to evaluate any difference in the long-term prognosis of patients with early stage breast cancer and obesity treated with BCT or total mastectomy (TM). DESIGN, SETTING AND PARTICIPANTS: This was a retrospective cohort study involving 1125 patients diagnosed with early stage breast cancer and obesity at the Shanghai Cancer Center of Fudan University from 2013 to 2016. OUTCOME MEASURES: Obesity in the Chinese population was defined as a body mass index ≥28 kg/m2. Surgical options included BCT and TM. The primary survival outcomes were overall survival (OS), disease-free survival (DFS) and recurrence-free survival (RFS). Inverse probability of treatment weighting (IPTW) was used to control for the impact of confounding factors on prognosis. RESULTS: The median follow-up times in the BCT group and TM group without postoperative RT were 51.1 months (IQR of 40.6-68.1 months) and 61.8 months (IQR of 46.5-76.7 months), respectively. After IPTW, the baseline data were balanced. Compared with those in the TM cohort, patients in the whole IPTW cohort in the BCT cohort had worse DFS (HR 4.280, 95% CI 2.180 to 8.400; p<0.001), RFS (HR 4.380, 95% CI 2.370 to 8.120; p<0.001) and OS (HR 3.590, 95% CI 1.620 to 7.950; p=0.002). CONCLUSION: In patients with early stage breast cancer and obesity, TM is associated with better survival outcomes than BCT.

RecurIndex-Guided postoperative radiotherapy with or without Avoidance of Irradiation of regional Nodes in 1-3 node-positive breast cancer (RIGAIN): a study protocol for a multicentre, open-label, randomised controlled prospective, phase III trial.

INTRODUCTION: Postoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1-2N1M0 cohort with a low clinical risk of local-regional recurrence (LRR), has incited a discourse surrounding personalised treatment strategies. Multigene testing for Recurrence Index (RecurIndex) model capably differentiates patients based on their level of LRR risk. This research aims to validate whether a more aggressive treatment approach can enhance clinical outcomes in N1 patients who possess a clinically low risk of LRR, yet a high RecurIndex-determined risk of LRR. Specifically, this entails postoperative whole breast irradiation combined with regional lymph node irradiation (RNI) following breast-conserving surgery or chest wall irradiation with RNI after mastectomy. METHODS AND ANALYSIS: The RIGAIN (RecurIndex-Guided postoperative radiotherapy with or without Avoidance of Irradiation of regional Nodes in 1-3 node-positive breast cancer) Study is a multicentre, prospective, randomised, open-label, phase III clinical trial that is being conducted in China. In this study, patients with low clinical LRR risk but high RecurIndex-LRR risk are randomly assigned in a 1:1 ratio to the experimental group or the control group. In the experimental group, RNI is performed and the control group omits RNI. Efficacy and safety analyses will be conducted, enrolling a total of 540 patients (270 per group). The primary endpoint is invasive disease-free survival, and secondary endpoints include any first recurrence, LRR-free survival, distant metastasis-free survival, recurrence-free survival, overall survival, disease-free survival, breast cancer-specific mortality and assessment of patient quality of life. The study began in April 2023 and with a follow-up period of 60 months after the last participant completes radiation therapy. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University (SYSKY-2022-097-02, V.3.1). It adheres to the Helsinki Declaration and Good Clinical Practice. Research findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04069884.

Deep learning radiomics based on multimodal imaging for distinguishing benign and malignant breast tumours.

Objectives: This study aimed to develop a deep learning radiomic model using multimodal imaging to differentiate benign and malignant breast tumours. Methods: Multimodality imaging data, including ultrasonography (US), mammography (MG), and magnetic resonance imaging (MRI), from 322 patients (112 with benign breast tumours and 210 with malignant breast tumours) with histopathologically confirmed breast tumours were retrospectively collected between December 2018 and May 2023. Based on multimodal imaging, the experiment was divided into three parts: traditional radiomics, deep learning radiomics, and feature fusion. We tested the performance of seven classifiers, namely, SVM, KNN, random forest, extra trees, XGBoost, LightGBM, and LR, on different feature models. Through feature fusion using ensemble and stacking strategies, we obtained the optimal classification model for benign and malignant breast tumours. Results: In terms of traditional radiomics, the ensemble fusion strategy achieved the highest accuracy, AUC, and specificity, with values of 0.892, 0.942 [0.886-0.996], and 0.956 [0.873-1.000], respectively. The early fusion strategy with US, MG, and MRI achieved the highest sensitivity of 0.952 [0.887-1.000]. In terms of deep learning radiomics, the stacking fusion strategy achieved the highest accuracy, AUC, and sensitivity, with values of 0.937, 0.947 [0.887-1.000], and 1.000 [0.999-1.000], respectively. The early fusion strategies of US+MRI and US+MG achieved the highest specificity of 0.954 [0.867-1.000]. In terms of feature fusion, the ensemble and stacking approaches of the late fusion strategy achieved the highest accuracy of 0.968. In addition, stacking achieved the highest AUC and specificity, which were 0.997 [0.990-1.000] and 1.000 [0.999-1.000], respectively. The traditional radiomic and depth features of US+MG + MR achieved the highest sensitivity of 1.000 [0.999-1.000] under the early fusion strategy. Conclusion: This study demonstrated the potential of integrating deep learning and radiomic features with multimodal images. As a single modality, MRI based on radiomic features achieved greater accuracy than US or MG. The US and MG models achieved higher accuracy with transfer learning than the single-mode or radiomic models. The traditional radiomic and depth features of US+MG + MR achieved the highest sensitivity under the early fusion strategy, showed higher diagnostic performance, and provided more valuable information for differentiation between benign and malignant breast tumours.

Helping ourselves, helping others: the Young Women's Breast Cancer Study (YWS) - a multisite prospective cohort study to advance the understanding of breast cancer diagnosed in women aged 40 years and younger.

PURPOSE: Compared with older women diagnosed with breast cancer, younger women are more likely to die of breast cancer and more likely to suffer psychosocially in both the short-term and long term. The Young Women's Breast Cancer Study (YWS) is a multisite prospective cohort study established to address gaps in our knowledge about this vulnerable and understudied population. PARTICIPANTS: The YWS enrolled 1302 women newly diagnosed with stages 0-IV breast cancer at age 40 years or younger at 13 academic and community sites in North America between 2006 and 2016. Longitudinal patient-reported outcome data are complemented by clinical data abstraction and biospecimen collection at multiple timepoints. FINDINGS TO DATE: Key findings related to fertility include that nearly 40% of participants were interested in pregnancy following diagnosis; of those who reported interest, 10% pursued fertility preservation. Overall, approximately 10% of YWS participants became pregnant in the first 5 years after diagnosis; follow-up is ongoing for pregnancies after 5 years. Studies focused on psychosocial outcomes have characterised quality of life, post-traumatic stress and fear of recurrence, with findings detailing the factors associated with the substantial psychosocial burden many young women face during and following active treatment. Multiple studies have leveraged YWS biospecimens, including whole-exome sequencing of tumour analyses that revealed that select somatic alterations occur at different frequencies in young (age≤35) versus older women with luminal A breast cancer, and a study that explored clonal hematopoiesis of indeterminate potential found it to be rare in young survivors. FUTURE PLANS: With a median follow-up of approximately 10 years, the cohort is just maturing for many relevant long-term outcomes and provides outstanding opportunities to further study and build collaborations to address gaps in our knowledge, with the ultimate objective to improve care and outcomes for young women with breast cancer. TRIAL REGISTRATION NUMBER: NCT01468246.

Mapping the cited evidence of ductal carcinoma in situ from the 5th edition of the World Health Organisation classification of tumours of the breast.

AIMS: Ductal carcinoma in situ (DCIS) is recognised by the World Health Organisation (WHO) Classification of Tumours (WCT) as a non-invasive neoplastic epithelial proliferation confined to the mammary ducts and lobules. This report categorises the references cited in the DCIS chapter of the 5th edition of the WCT (Breast Tumours) according to prevailing evidence levels for evidence-based medicine and the Hierarchy of Evidence for Tumour Pathology (HETP), identifying potential gaps that can inform subsequent editions of the WCT for this tumour. METHODS AND RESULTS: We included all citations from the DCIS chapter of the WCT (Breast Tumours, 5th edition). Each citation was appraised according to its study design and evidence level. We developed our map of cited evidence, which is a graphical matrix of tumour type (column) and tumour descriptors (rows). Spheres were used to represent the evidence, with size and colour corresponding to their number and evidence level respectively. Thirty-six publications were retrieved. The cited literature in the DCIS chapter comprised mainly case series and were regarded as low-level. We found an unequal distribution of citations among tumour descriptors. 'Pathogenesis' and 'prognosis and prediction' contained the most references, while 'clinical features', 'aetiology' and 'diagnostic molecular pathology' had only a single citation each. 'Prognosis and prediction' had the greatest proportion of moderate- and high-levels of evidence. CONCLUSION: Our findings align with the disposition for observational studies inherent in the field of pathology. Our map is a springboard for future efforts in mapping all available evidence on DCIS, potentially augmenting the editorial process and future editions of WCTs.

Ultrasound-based comparative analysis and nomogram development for predicting triple-negative and non-triple-negative breast cancer: a 4-year institutional study in Quanzhou First Hospital.

OBJECTIVE: The objective of this study was to compare ultrasound features and establish a predictive nomogram for distinguishing between triple-negative breast cancer (TNBC) and non-TNBC. DESIGN: A retrospective cohort study. SETTING: This study was conducted at Quanzhou First Hospital, a grade A tertiary hospital in Quanzhou, China, with the research data set covering the period from September 2019 to August 2023. PARTICIPANTS: The study included a total of 205 female patients with confirmed TNBC and 574 female patients with non-TNBC, who were randomly divided into a training set and a validation set at a ratio of 7:3. MAIN OUTCOME MEASURES: All patients underwent ultrasound examination and received a confirmatory pathological diagnosis. Nodules were classified according to the Breast Imaging-Reporting and Data System standard. Subsequently, the study conducted a comparative analysis of clinical characteristics and ultrasonic features. RESULTS: A statistically significant difference was observed in multiple clinical and ultrasonic features between TNBC and non-TNBC. Specifically, in the logistic regression analysis conducted on the training set, indicators such as posterior echo, lesion size, presence of clinical symptoms, margin characteristics, internal blood flow signals, halo and microcalcification were found to be statistically significant (p<0.05). These significant indicators were then effectively incorporated into a static and dynamic nomogram model, demonstrating high predictive performance in distinguishing TNBC from non-TNBC. CONCLUSION: The results of our study demonstrated that ultrasound features can be valuable in distinguishing between TNBC and non-TNBC. The presence of posterior echo, size, clinical symptoms, margin, internal flow, halo and microcalcification was identified as predictive factors for this differentiation. Microcalcification, hyperechoic halo, internal flow and clinical symptoms emerged as the strongest predictive factors, indicating their potential as reliable indicators for identifying TNBC and non-TNBC.

Non-pharmaceutical interventions for depressive symptoms in patients with breast cancer: protocol for a systematic review and network meta-analysis.

INTRODUCTION: Patients with breast cancer often suffer from depressive symptoms throughout various stages of cancer, significantly impacting their quality of life and treatment outcomes. Non-pharmaceutical interventions such as psychotherapy, mind-body therapies and physical exercise have shown effectiveness in addressing cancer-related depression. However, the efficacy and safety of different non-pharmacological interventions remain a topic of debate. Therefore, to provide an objective assessment and comparison of the impact of different non-pharmaceutical interventions on depression, we will conduct a network meta-analysis (NMA) to explore the effects of different non-pharmaceutical interventions on reducing depressive symptoms among patients with breast cancer. METHODS AND ANALYSIS: We will search nine Chinese and English-language databases, from database inception to 31 July 2023, for randomised controlled trials published in Chinese or English. The English-language databases are PubMed, Medline, Embase, Web of Science and Cochrane Central Register of Controlled Trials, and the Chinese databases are CBM, CNKI, VIP and Wanfang. Two independent researchers will perform information extraction from eligible articles. The primary outcome will be the changes in depressive symptoms, while the secondary outcome will include adverse events. STATA V.15.0 will be used to conduct paired meta-analysis and NMA. Grading of Recommendations Assessment, Development and Evaluation will be used to assess the quality of evidence, and the Cochrane tool for assessing the risks of bias in randomised trials V.2 will be used for risk of bias assessment. ETHICS AND DISSEMINATION: The study does not require ethical approval as it will analyse data from existing studies. It is expected that the results of the study will be published in peer-reviewed journals and presented at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42023450494.

Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention.

OBJECTIVES: This study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico. DESIGN: We conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility. PARTICIPANTS: 50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers. SETTING: Oncology services in three public hospitals of the Mexican Social Security Institute. INTERVENTION: The ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks. RESULTS: 50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms. CONCLUSIONS: This pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID: NCT05925257.

Practice of breast self-examination and associated factors among women of reproductive age in the North Shoa Zone, Oromia, Ethiopia, 2022: a convergent mixed-methods study.

OBJECTIVE: To assess practice of breast self-examination (BSE) and associated factors among women of reproductive age in the North Shoa Zone, Oromia, Ethiopia. DESIGN: Community-based cross-sectional study with a convergent mixed-methods approach. SETTING: The study was conducted in the North Shoa Zone of Oromia, Central Ethiopia, between 1 May 2022 and 30 June 2022. PARTICIPANTS: 1076 women of reproductive age were selected using simple random sampling technique for the quantitative study. For the qualitative part, a total of 46 women were approached purposively to elicit rich ideas and insight into the issue. The quantitative data were collected using an interviewer-administered questionnaire, and focus group discussions were used for the qualitative part. Quantitative data were analysed using SPSS V.26. An adjusted OR with a 95% CI was employed. Thematic analysis approach was applied for the qualitative data analysis. OUTCOME MEASURES: Participants were interviewed to respond whether they practised BSE. RESULTS: Overall, 192 (18.2%; 15.7%-20.5%) of the participants had ever performed BSE. Having a family history of breast cancer (BC) (adjusted OR (AOR)=6.9, 95% CI 4.6 to 10.3), being knowledgeable on BSE (AOR=3, 95% CI 1.9 to 4.3), having high perceived susceptibility (AOR=1.7, 95% CI 1.2 to 2.5), having high self-efficacy (AOR=1.5, 95% CI 1.1 to 2.3) and having a high perceived benefit to BSE (AOR=1.5, 95% CI 1.1 to 2.3) were significantly associated with increased odds of BSE practice.Four main themes emerged from the qualitative analysis: BC and BSE-related knowledge, perceived benefits of treatment, barriers to BSE practice and enablers of BSE practice. CONCLUSION: The practice of BSE in this area was considerably low. The North Shoa Zonal Health Office and other stakeholders should disseminate instructional materials that cover the techniques and benefits of regularly performing BSE. Healthcare professionals should engage in the community to address the obstacles women face in practising BSE.

Prognostic factors for the development of upper limb dysfunctions after breast cancer: the UPLIFT-BC prospective longitudinal cohort study protocol.

INTRODUCTION: Upper limb (UL) dysfunctions are highly prevalent in people after breast cancer and have a great impact on performing activities in daily living. To improve care, a more comprehensive understanding of the development and persistence of UL dysfunctions is needed. Therefore, the UPLIFT-BC study will primarily examine the prognostic value of different factors at the body functions and structures, environmental and personal level of the International Classification of Functioning, Disability and Health (ICF) framework at 1-month post-surgery for persisting UL dysfunctions at 6 months after finishing cancer treatment. METHODS AND ANALYSIS: A prospective longitudinal cohort study, running from 1-week pre-surgery to 6 months post-local cancer treatment, is performed in a cohort of 250 women diagnosed with primary breast cancer. Different potentially prognostic factors to UL dysfunctions, covering body functions and structures, environmental and personal factors of the ICF, are assessed pre-surgically and at different time points post-surgery. The primary aim is to investigate the prognostic value of these factors at 1-month post-surgery for subjective UL function (ie, QuickDASH) at 6 months post-cancer treatment, that is, 6 months post-radiotherapy or post-surgery (T3), depending on the individuals' cancer treatment trajectory. In this, factors with relevant prognostic value pre-surgery are considered as well. Similar analyses are performed with an objective measure for UL function (ie, accelerometry) and a composite score of the combination of subjective and objective UL function. Second, in the subgroup of participants who receive radiotherapy, the prognostic value of the same factors is explored at 1-month post-radiotherapy and 6 months post-surgery. A forward stepwise selection strategy is used to obtain these multivariable prognostic models. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of UZ/KU Leuven (reference number s66248). The results of this study will be published in peer-reviewed journals and will be presented at several research conferences. TRIAL REGISTRATION NUMBER: NCT05297591.

Protocol for evaluating the fitness for purpose of an artificial intelligence product for radiology reporting in the BreastScreen New South Wales breast cancer screening programme.

INTRODUCTION: Radiologist shortages threaten the sustainability of breast cancer screening programmes. Artificial intelligence (AI) products that can interpret mammograms could mitigate this risk. While previous studies have suggested this technology has accuracy comparable to radiologists most have been limited by using 'enriched' datasets and/or not considering the interaction between the algorithm and human readers. This study will address these limitations by comparing the accuracy of a workflow using AI alongside radiologists on a large consecutive cohort of examinations from a breast cancer screening programme. The study will combine the strengths of a large retrospective design with the benefit of prospective data collection. It will test this technology without risk to screening programme participants nor the need to wait for follow-up data. With a sample of 2 years of consecutive screening examinations, it is likely the largest test of this technology to date. The study will help determine whether this technology can safely be introduced into the BreastScreen New South Wales (NSW) population-based screening programme to address radiology workforce risks without compromising cancer detection rates or increasing false-positive recalls. METHODS AND ANALYSIS: A retrospective, consecutive cohort of digital mammography screens from 658 207 examinations from BreastScreen NSW will be reinterpreted by the Lunit Insight MMG AI product. The cohort includes 4383 screen-detected and 1171 interval cancers. The results will be compared with radiologist single reading and the AI results will also be used to replace the second reader in a double-reading model. New adjudication reading will be performed where the AI disagrees with the first reader. Recall rates and cancer detection rates of combined AI-radiologist reading will be compared with the rates obtained at the time of screening. ETHICS AND DISSEMINATION: This study has ethical approval from the NSW Health Population Health Services Research Ethics Committee (2022/ETH02397). Findings will be published in peer-reviewed journals and presented at conferences. The findings of this evaluation will be provided to programme managers, governance bodies and other stakeholders in Australian breast cancer screening programmes.

Role of Gut Microbe Composition in Psychosocial Symptom Response to Exercise Training in Breast Cancer Survivors (ROME) study: protocol for a randomised controlled trial.

INTRODUCTION: Breast cancer survivors have an increased risk for chronic fatigue and altered gut microbiota composition, both with negative health and quality of life affects. Exercise modestly improves fatigue and is linked to gut microbial diversity and production of beneficial metabolites. Studies suggest that gut microbiota composition is a potential mechanism underlying fatigue response to exercise. Randomised controlled trials testing the effects of exercise on the gut microbiome are limited and there is a scarcity of findings specific to breast cancer survivors. The objective of this study is to determine if fitness-related modifications to gut microbiota occur and, if so, mediate the effects of aerobic exercise on fatigue response. METHODS AND ANALYSIS: The research is a randomised controlled trial among breast cancer survivors aged 18-74 with fatigue. The primary aim is to determine the effects of aerobic exercise training compared with an attention control on gut microbiota composition. The secondary study aims are to test if exercise training (1) affects the gut microbiota composition directly and/or indirectly through inflammation (serum cytokines), autonomic nervous system (heart rate variability) or hypothalamic-pituitary-adrenal axis mediators (hair cortisol assays), and (2) effects on fatigue are direct and/or indirect through changes in the gut microbiota composition. All participants receive a standardised controlled diet. Assessments occur at baseline, 5 weeks, 10 weeks and 15 weeks (5 weeks post intervention completion). Faecal samples collect the gut microbiome and 16S gene sequencing will identify the microbiome. Fatigue is measured by a 13-item multidimensional fatigue scale. ETHICS AND DISSEMINATION: The University of Alabama at Birmingham Institutional Review Board (IRB) approved this study on 15 May 2019, UAB IRB#30000320. A Data and Safety Monitoring Board convenes annually or more often if indicated. Findings will be disseminated in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT04088708.