Test Procedure Research Articles

MR Safety of Inductively Coupled and Conventional Intraoral Coils.

Intraoral coils (IOCs) in magnetic resonance imaging (MRI) significantly improve the signal-to-noise ratio compared with conventional extraoral coils. To assess the safety of IOCs, we propose a 2-step procedure to evaluate radiofrequency-induced heating of IOCs and compare maximum temperature increases in 3 different types of IOCs. The 2-step safety assessment consists of electric field measurements and simulations to identify local hotspots followed by temperature measurements during MRI. With this method, 3 different coil types (inductively coupled IFC, transmit/receive tLoop, and receive-only tLoopRx) were tested at 1.5 T and 3 T for both tuned and detuned coil states. High SAR and regular MRI protocols were applied for 2 coil positions. The measured E field maps display distinct hotspots for all tuned IOCs, which were reduced by at least 40-fold when the IOCs were detuned. Maximum temperature rise was higher when the coils were positioned at the periphery of the phantom with the coil planes parallel to B0. When neither active nor passive detuning was applied, maximum temperature increase of ΔT = 1.3/0.5/1.8 K was found for IFC/tLoop/tLoopRx coils. Hotspots detected by E field measurements, and simulations were consistent. In the simulations, the results were different for homogeneous phantoms compared with full anatomical models. The 2-step test procedure is applicable to different coil types. The results indicate that a risk for radiofrequency-induced heating exists for tuned IOCs, so that adequate detuning circuits need to be integrated in the coils to ensure safe operation.

Recognizing Sign Language using Machine Learning and Deep Learning Models

Individuals with hearing impairments communicate mostly through sign language. Our goal was to create an American Sign Language recognition dataset and utilize it in a neural network-based machine learning model that can interpret hand gestures and positions into natural language. In our study, we incorporated the SVM, CNN and Resnet-18 models to enhance predictability when interpreting ASL signs through this new dataset, which includes provisions such as lighting and distance limitations. Our research also features comparison results between all the other models implemented under invariant conditions versus those using our proposed CNN model. As demonstrated by its high levels of precision at 95.10% despite changes encountered during testing procedures like varying data sets or scene configurations where losses are minimal (0.545), there exists great potential for future applications in image recognition systems requiring deep learning techniques. Furthermore, these advancements may lead to significant improvements within various fields related explicitly to speech-language therapy sessions designed specifically around helping people overcome challenges associated with deafness while building bridges towards improved social integration opportunities.

Biomechanical Integrity Score of the Female Pelvic Floor for Stress Urinary Incontinence.

This study is aimed at developing and validating a new integral parameter, the Biomechanical Integrity score (BI-score) of the female pelvic floor for stress urinary incontinence conditions. A total of 130 subjects were included in the observational cohort study; 70 subjects had normal pelvic floor conditions, and 60 subjects had stress urinary incontinence (SUI). A Vaginal Tactile Imager (VTI) was used to acquire and automatically calculate 52 biomechanical parameters for eight VTI test procedures (probe insertion, elevation, rotation, Valsalva maneuver, voluntary muscle contractions in two planes, relaxation, and reflex contraction). Statistical methods were applied (t test, correlation) to identify the VTI parameters sensitive to the pelvic SUI conditions. Twenty-seven parameters were identified as statistically sensitive to SUI development. They were subdivided into five groups to characterize tissue elasticity (group 1), pelvic support (group 2), pelvic muscle contraction (group 3), involuntary muscle relaxation (group 4), and pelvic muscle mobility (group 5). Every parameter was transformed to its standard deviation units using the dataset for normal pelvic conditions, similar to the T-score for bone density. Linear combinations with specified weights led to the composition of five component parameters for groups 1-5 and to the BI-score in standard deviation units. The p value for the BI-score has p = 4.0 × 10-28 for SUI versus normal conditions. Quantitative transformations of the pelvic tissues, support structures, and functions under diseased conditions may be studied with the SUI BI-score in future research and clinical applications.

Profilometry‐Based Indentation Plastometry and Uniaxial Testing of Pipelines: Detection of In‐Plane Anisotropy and Potential for Simplification of Test Procedures

This article concerns anisotropy in stress–strain relationships exhibited by steel pipelines. Since the stress from internal pressurization is highest in the hoop direction, standard industrial practice to measure these properties has focussed on tensile testing in this direction, requiring a prior flattening operation. The associated plastic deformation may affect properties, typically causing a (poorly‐defined) degree of hardening and the creation of inhomogeneity. Field testing of such pipelines, requiring in situ measurement of tensile properties (yield stress (YS) and ultimate tensile stress (UTS)), is based on indentation testing of the outer surface. One such test (profilometry‐based indentation plastometry (PIP)), not only gives the stress–strain curve, but also allows detection of any (in‐plane) anisotropy, with a high sensitivity. Both PIP testing and compression testing (with and without prior flattening) have confirmed that none of the eight pipes examined in the current work exhibited any such anisotropy, although the effects of flattening did tend to generate apparent anisotropy in the tensile test outcomes. It may therefore be appropriate to switch the focus of tensile testing to the axial direction, such that no flattening would be required.

Individual identification method using samples associated with doping tests: A comparison of mitochondrial and nuclear genetic data.

Doping offenses involve the use or attempted use of any prohibited method or substance as well as substituting samples. Consequently, it has been recommended that short tandem repeat (STR) analysis be used to determine if the doping control samples are from the same athlete. However, it has been recognized that it may be difficult to obtain full STR analysis using negligible amounts of DNA samples. Mitochondrial DNA (mtDNA) is characterized by its stability and high cellular copy number. Therefore, mtDNA testing in urine is expected to be used to analyze samples that cannot be analyzed using STR analysis. The objective of this study was to compare mtDNA testing with STR analysis by conducting sensitivity, concordance (whole blood, dried blood spot, and urine), and case-type studies. In sensitivity studies, mtDNA testing exhibited greater sensitivity compared with STR analysis. Concordance studies indicated that all samples were consistent with the mtDNA sequences and STR profiles. Allelic dropout occurred in some urine samples that were examined for STR analysis. Case-type sample studies demonstrated that mtDNA testing could be used to obtain DNA profiles of all the samples tested, including blood, dried blood spots, urine, blood residues on needles, and blood stains. In conclusion, mtDNA testing is valuable for analyzing highly degraded DNA samples, such as urine samples, compared with STR analysis. Urine testing should be performed for the initial testing procedure, because mtDNA is inherited maternally. In situations where the DNA match is detrimental to the athlete, additional blood STR analysis may be required.

Power Hardware-in-the-Loop Smart Inverter Testing with Distributed Energy Resource Management Systems

The increasing integration of grid-connected photovoltaic (PV) inverters and inverter-based resource (IBR) systems into the power grid emphasizes the critical need for standardized procedures to ensure their reliability and effective grid support functions. This research is driven by the gap in standardized testing methodologies for smart inverters, which are pivotal for the stability and quality of power in distributed energy systems. We used a Power Hardware-in-the-Loop (PHIL) laboratory setup to conduct a comprehensive analysis of smart inverters within a simulated real-world grid environment. Our approach integrates a Distributed Energy Resource Management System (DERMS) with PHIL testing to evaluate the smart inverter’s performance across various operational modes. The detailed test protocols mimic real-world grid conditions, enabling the examination of the inverter’s dynamic response to grid disturbances, control strategies, and communication protocols. The primary aim of this study is to rigorously test and validate the primary functions of smart inverters, focusing on their impact on overall grid stability and power quality management. This includes advanced features like Volt–VAR, Volt–Watt, dynamic power factor control, and the seamless integration of smart inverters into DERMSs and Advanced Distribution Management Systems (ADMSs). Furthermore, we aim to bridge the current gap in standardized testing procedures, contributing to the establishment of robust standards and operating protocols for smart inverter integration into the grid.

An Ad Hoc Procedure for Testing Serial Correlation in Spatial Fixed-Effects Panels

We consider testing for error persistence in spatial panels with (potentially correlated) individual heterogeneity. We propose two variants of an ad hoc testing procedure based on first transforming out the individual effects, either by time-demeaning or by taking forward orthogonal deviations, then estimating an encompassing spatio-temporal model. The procedure can also be employed under the random effects assumption, in which case, although suboptimal, it can be computationally cheaper and safer than existing tests. We report Monte Carlo simulations demonstrating satisfactory empirical properties.

Endothelial function in healthy centenarians living in the Madonie’s district (Italy)

BackgroundEndothelial function declines with age and plays a critical role in cardiovascular health. Therefore, investigating endothelial function in successful aging models, such as centenarians, is of interest. Flow-mediated dilation (FMD) of the brachial artery is the gold standard for measuring endothelial function in vivo in humans. Therefore, we investigated, for the first time, the FMD of the brachial artery in a group of healthy centenarians. MethodsSelected as part of the ABCD project (nutrition, cardiovascular wellness, and diabetes) centenarians (aged ≥100 years) living in the municipalities of Madonie (Palermo, Italy) were compared with a younger (aged <65 years) sex-matched control group from the ABCD general cohort. FMD of the brachial artery was measured in all participants using a real-time computed video analysis system for B-mode ultrasound images. Body composition (bioimpedance), carotid intima-media thickness (IMT), and ankle-brachial index (ABI) were also measured. ResultsEleven participants (males 36.4 %; age: 101 ± 1 years) out of 28 healthy centenarians successfully cooperated with the FMD test procedures, which require remaining with the upper limb immobile for approximately 10 min. This subgroup was compared with a control group of 76 healthy and younger individuals (males 36.8 %; aged: 41 ± 14 years; P < 0.001). Centenarians exhibited better endothelial function than the control group (FMD: 12.1 ± 4.3 vs 8.6 ± 5.3 %; P < 0.05). The carotid IMT was higher in the centenarian group than in the control group (0.89 ± 0.09 vs 0.56 ± 0.18 mm; P < 0.001), whereas the ABI was comparable between the two groups. ConclusionsThis small group of centenarians demonstrated an unusually favorable endothelial function, which may contribute to their unique aging profile. Further research is needed to determine whether FMD is a valid prognostic marker for successful aging.

Improved Test Procedure and Sample Size Calculation for Assessing Similarity in Two-Group Comparative Studies with Heterogeneous Variances

AbstractThe two one-sided tests (TOST) method for mean equivalence or average equivalence has been extended to assessing similarity or switchability for individual equivalence in clinical trials. Tolerance interval procedures are available to establish similarity with respect to the proportion of the response differences covered by a prespecified threshold range. However, the extended TOST procedures based on tolerance intervals are potentially susceptible to the control of Type I errors. This article aims to present an exact approach with the specified Type I error probability for appraising similarity between two treatments in comparative studies with heterogeneous variances. Analytic examination and numerical comparison are conducted to clarify the utility of the suggested similarity test and the drawback of the current TOST procedures. To enhance the usefulness of the described exact method, the related power and sample size issues are also considered. Computer algorithms are provided to implement the proposed test procedure, power calculation, and sample size determination in similarity studies.

Technological advances in artistic gymnastics and the impact on its development

This paper looks at the history of technology development in Artistic Gymnastics (AG) by reviewing patent registrations, test procedures for the AG competition equipment by the official control laboratory of the International Federation of Gymnastics (FIG), and major apparatus advances by manufacturers. Equipment became lighter and more resistant with synthetic materials, with a clear tendency to increase elastic (repulsive) capacity. It is noteworthy that the testing laboratory becomes an arbiter for the industry and the FIG when the technological developments and equipment of manufacturers are evaluated for official use. Only 23 companies have equipment approved by the FIG, 12 of them manufacturing AG apparatuses. Suppliers are located in nine different countries (2 in Asia; 4 in Europe; 2 in America; 1 in Oceania). There is still an unequal distribution of access to technologies, which are concentrated in the northern hemisphere. More access to the actual technology is clearly required when we consider that 156 national member federations are affiliated with the FIG as of this writing.

Prolongation of the gastric residence time of caffeine after administration in fed state: Comparison of effervescent granules with an extended release tablet

The aim of the present study was to investigate the gastroretentive capacity of different formulation principles. This was indirectly determined by the absorption behavior of caffeine from the dosage forms. A slow and continuous appearance of caffeine in the saliva of healthy volunteers was used as a parameter for a prolonged gastric retention time. For this purpose, a four-way study was conducted with twelve healthy volunteers using the following test procedures: (1) Effervescent granules with 240 mL of still water administered in fed state, (2) effervescent granules with 20 mL of still water in fed state, (3) extended release (ER) tablet with 240 mL of still water in fed state, and (4) effervescent granules with 240 mL of still water in fasted state. The initial rise of the caffeine concentrations was more pronounced after the intake of the effervescent granules in the fed state compared to that of the ER tablets. However, tmax tended to be shorter in the fed study arms following administration of the ER tablet compared to the granules. Overall, the application of active pharmaceutical ingredients formulated as effervescent granules seems to be a promising approach to increase their gastric residence time after intake in fed state.

Challenges of Green Transition in Polymer Production: Applications in Zero Energy Innovations and Hydrogen Storage

The green transition in the sustainable production and processing of polymers poses multifaceted challenges that demand integral comprehensive solutions. Specific problems of presences of toxic trace elements are often missed and this prevents shifting towards eco-friendly alternatives. Therefore, substantial research and the development of novel approaches is needed to discover and implement innovative, sustainable production materials and methods. This paper is focused on the most vital problems of the green transition from the aspect of establishing universally accepted criteria for the characterization and classification of eco-friendly polymers, which is essential to ensuring transparency and trust among consumers. Additionally, the recycling infrastructure needs substantial improvement to manage the end-of-life stage of polymer products effectively. Moreover, the lack of standardized regulations and certifications for sustainable polymers adds to the complexity of this problem. In this paper we propose solutions from the aspect of standardization protocols for the characterization of polymers foreseen as materials that should be used in Zero Energy Innovations in Hydrogen Storage. The role model standards originate from eco-labeling procedures for materials that come into direct or prolonged contact with human skin, and that are monitored by different methods and testing procedures. In conclusion, the challenges of transitioning to green practices in polymer production and processing demands a concerted effort from experts in the field which need to emphasize the problems of the analysis of toxic ultra trace and trace impurities in samples that will be used in hydrogen storage, as trace impurities may cause terrific obstacles due to their decreasing the safety of materials. Overcoming these obstacles requires the development and application of current state-of-the-art methodologies for monitoring the quality of polymers during their recycling, processing, and using, as well as the development of other technological innovations, financial initiatives, and a collective commitment to fostering a sustainable and environmentally responsible future for the polymer industry and innovations in the field of zero energy applications.

Does prior misconduct predict drug use by police?

ABSTRACT Recent research has yielded important insight into the characteristics and behaviours of officers who commit misconduct across the UK, USA and Australia. However, there remains little research into illicit substance use by sworn police. Considering substance use by police through the lens of police misconduct, this paper employs correlation and regression analyses using a sample of 489 sworn officers, to analyse whether individual types of misconduct, or the overall volume of misconduct committed, were predictive of an officer returning a positive drug test during departmental random drug testing. Findings suggested that neither individual types of misconduct, or the overall number of complaints received by officers were useful in predicting a positive drug test. However, a current or historical association with a known offender held a strong relationship with returning a positive drug test. Pivotally, holding a second job (outside of the agency) was also a significant predictor of a positive drug test. The findings of this research hold important implications for drug testing policy and procedure of policing agencies, and for understanding which factors may suggest that an officer is at risk of drug use.

Testing for auto-calibration with Lorenz and Concentration curves

Dominance relations and diagnostic tools based on Lorenz and Concentration curves in order to compare competing estimators of the regression function have recently been proposed. This approach turns out to be equivalent to forecast dominance when the estimators under consideration are auto-calibrated. A new characterization of auto-calibration is established, based on the graphs of Lorenz and Concentration curves. This result is exploited to propose an effective testing procedure for auto-calibration. A simulation study is conducted to evaluate its performances and its relevance for practice is demonstrated on an insurance data set.

Adaptive two-stage seamless sequential design for clinical trials

ABSTRACT We propose an adaptive sequential testing procedure for the selection and testing of multiple treatment options, such as dose/regimen, different drugs, sub-populations, endpoints, or a mixture of them in a seamlessly combined phase II/III trial. The selection is to be made at the end of phase 2 stage. Unlike in many of the published literature, the selection rule is not required to be to “select the best”, and does not need to be pre-specified, which provides flexibility and allows the trial investigators to use any efficacy and safety information/criteria, or surrogate or intermediate endpoint to make the selection. Sample size and power calculations are provided. The calculations have been confirmed to be accurate by simulations. Interim analysis can be performed after the selection, sample size can be modified if the observed efficacy deviates from the assumed. Inference after the trial, including p-value, median unbiased point estimate and confidence intervals, are provided. By applying a dominance theorem, the procedure can be applied to normal, binary, Poisson, negative binomial distributed endpoints and time-to-event endpoints, and a mixture of these distributions (in trials involving endpoint selection).

Regolith mapping using airborne gamma-ray spectrometry in central Brazil

In deeply weathered terrains, with high geological diversity and scarce outcrops, the lateritic regolith features support mineral research. Predictive regolith mapping uses spatial modeling and airborne gamma-ray spectrometric data to locate weathered residual products, such as the ferruginous lateritic duricrusts found in tropical regions. Although the regolith materials exhibit qualitative similarities in their gamma-ray spectrometric responses in RGB (KThU) images, the Boolean and fuzzy approaches highlighted differences that allows for mapping the regolith weathering residual products on a wide geodiversity protoliths. Two inference systems were used, one identified the ferruginous lateritic duricrusts and oxisols derived from the felsic/pelitc and mafic rocks types (TP test procedures), and the other identified solely those derived exclusively from mafic rocks (TPM test procedures). Cutoff values for the conjunction eTh/K ∩ eU/K ∩ eTh ∩ K (TP-4) using Boolean logic, provided the most accurate regolith map (accuracy = 95%) among the various tests carried out and indicate that in 28.6% of the total study area, there are lateritic duricrust and oxisols relative to rocks, saprolites, mottled horizons and other soils type. The eTh cutoff value > 4.4 ppm was used to exclude mafic rocks and associated soils, and the K value < 1.3% to exclude rocks with eTh/K and eU/K values similar to the lateritic duricrusts and oxisols. For mapping the lateritic duricrusts derived exclusively from the mafic rocks the conjunction of eTh ∩ eU/K ∩ eTh/K ∩ K ∩ eU (TPM-3) fuzzified by the large membership function was the most efficient. The eU variable with values < 1.21 ppm helps improve the effectiveness of this procedure. The generated predictive map indicated that in about ∼12% (657.9 km2) of the total study area, there are lateritic duricrusts and oxisols derived from mafic rocks. Therefore, a successful method of mapping vast areas from complicated lateritic regolith mosaic derived from a large geodiversity is to apply specific plugins for data fuzzification, supported by observations from field outcrops.

A thermogravimetric comparative study of the high temperature steam oxidation of bare and pre-oxidized Zircaloy-4, M5Framatome and Optimized ZIRLO™

For Loss of Coolant Accident (LOCA) analysis, high-temperature oxidation kinetics in steam of Zircaloy-4 and the two Nb-bearing alloys used in French Pressurized Water Reactors (PWRs), M5Framatome11M5 and M5Framatome are trademarks or registered trademarks of Framatome or its affiliates, in the USA or other countries. and Optimized ZIRLO™22Optimized ZIRLO is a trademark or registered trademark of Westinghouse Electric Company LLC, its affiliates and/or its subsidiaries in the United States and may be registered in other countries throughout the world. All rights reserved. Unauthorized use is strictly prohibited. Other names may be trademarks of their respective owners., have been studied using Thermo-Gravimetric Analysis (TGA) technique in the temperature range of 900–1200 °C. A specific test procedure allowing the use of a high steam flow rate and good steam supply to the whole specimen surface, as well as fast heating of the specimen, has been developed. Clean kinetic data, not affected by steam starvation, were obtained on the bare, as-received alloys. For as-received claddings, oxidation kinetics are comparable and close to parabolic for the three alloys at 1100 °C and above. Below 1100 °C, a significant deviation from the parabolic kinetic regime was observed, and M5 Framatome oxidizes slower than Zircaloy-4 and Optimized ZIRLO. Thanks to the fast-heating protocol, the influence of pre-oxidation, simulating corrosion in normal reactor operation, could be investigated, avoiding evolution of the pre-oxidation scale during a slow, long heating phase. Pre-oxidized Zircaloy-4 and M5 Framatome were investigated. A strong protective effect is observed below 1200 °C, while at 1200 °C, the pre-oxidation layer appears to be much less protective, possibly due to the monoclinic to tetragonal zirconia phase transformation.

Development of Testing Procedures to Study the Impact of Erosion Voids on Buried Pipes

Development of Testing Procedures to Study the Impact of Erosion Voids on Buried Pipes

Greenhouse gas reduction in a medium-duty compression ignition engine with optimization for B20

Soy-based biodiesel can reduce well-to-wheels greenhouse gas (GHG) emissions per unit energy (i.e., gCO2e/MJ) by 66%–72% as compared to the petroleum-based diesel fuel with currently adopted agricultural and industrial practices. Biodiesel can reduce particulate matter and carbon monoxide emissions with a manageable degree of increase in NOx emissions. From the perspective of GHG emissions reduction per unit travelling distance (i.e., gCO2e/mile), the application of B20 in compression ignition engines without the adjustment in engine control unit (ECU) settings will not extract the best carbon emissions reduction that B20 could achieve. Optimizing the engine control settings permits re-calibration to achieve the maximum brake fuel conversion efficiency (BFE) based on comprehensive understanding on the impact of both “fuel” and “ECU calibration” on BFE and other criteria pollutant emissions. The maximum GHG emissions reduction with B20 application is experimentally measured with the optimized ECU calibration, thus providing the understanding of the combined impact of biodiesel fuel and calibrations on engine performance and emissions. Six steady operating modes were considered, that can be combined to estimate the US federal test procedure BFE and emissions over the Federal Test Protocol (FTP) 75 cycle. Combined with the weight factors to simulate the EPA FTP 75 cycle from these 6 “mini-map” test points, 0.53% improvement in the energy requirement per unit traveling distance (i.e., MJ/mile) is achieved for B20 with the final ECU calibration, in addition to the degree of GHG emissions reduction on a “gCO2e/MJ” basis from the use of B20 blend of soy biodiesel of ∼12.5% reduction in gCO2e/MJ, for a total GHG emissions reduction of 13%.

Abstract PO1-27-05: De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab in HER2-positive early breast cancer (HELEN-006):a randomized,phase 3 trial

Abstract Background: Chemotherapy de-escalation is currently under investigation as a treatment approach for HER2-positive early-stage breast cancer(EBC). We conducted a phase 3 clinical trial to evaluate the effectiveness of a weekly regimen of nab-paclitaxel monotherapy in combination with dual HER2 blockade for HER2-positive EBC. Methods: We conducted a multicenter, randomized, open-label Phase 3 trial at six hospitals in China. Eligible participants were women aged 18-70 with locally confirmed, HER2-positive, stage II-III, invasive, operable breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. Participants were randomly assigned (1:1) using central block randomization, with block sizes of four, stratified by hormone receptor status, tumor stage, and node status. They were assigned to receive either intravenous nab-paclitaxel (125mg/m2 on days 1, 8, and 15) for six 3-week cycles (group A), or intravenous docetaxel (75mg/m² on day 1) and carboplatin (area under the concentration-time curve 6mg/mL per min on day 1) for six 3-week cycles (group B). Both groups received concurrent trastuzumab (8mg/m2 loading dose, 6mg/m2 maintenance dose on day 1) and pertuzumab (intravenous 840mg loading dose, 420mg maintenance dose on day 1). The primary endpoint was the proportion of patients achieving a pathological complete response(pCR) in the breast and axilla (ypT0/is ypN0) as determined by a local pathologist after surgery, assessed using a modified intention-to-treat analysis. To test for non-inferiority, we used a closed test procedure, considering the nab-paclitaxel group non-inferior to the docetaxel plus carboplatin group if the lower 95% confidence interval(CI) for the odds ratio (OR) was above 0.802, which accounted for a 5.5% non-inferiority margin (10% of the 55% pCR rate for docetaxel plus carboplatin and dual HER2 blockade regimen). We planned to test for superiority only if the non-inferiority test was positive, using an alpha value of 0.05. Safety was assessed in all patients who received the study drug. The trial is registered with ClinicalTrials.gov, with the registration number NCT04547907. Findings: Between September 10, 2020, and March 1, 2023, we randomly assigned 689 women, of whom 669 started treatment (332 with nab-paclitaxel and 337 with docetaxel plus carboplatin). The nab-paclitaxel group had a higher proportion of patients achieving a pCR (220 [66.3%, 95% CI 61.2-71.4]) compared to the docetaxel plus carboplatin group (194 [57.6%, 52.3-62.9]). The OR for pCR was 1.448 (95% CI 1.058-1.981), indicating a statistically significant difference (unadjusted p=0.021). Overall, 228 (34.1%) patients were noted to have at least one grade 3 or 4 event, 100(30.1%) in the nab-paclitaxel group and 128 (38.0%) in the docetaxel plus carboplatin group (P=0·032). The most common grade 3 or 4 events overall were nausea (98[14.6%] of 669 patients), diarrhea (80 [12.0%]), and neuropathy (51 [7.6%]).However, no treatment-associated deaths were identified. Conclusions: In neoadjuvant treatment of HER2-positive EBC, 18 weeks of nab-paclitaxel monotherapy combined with dual HER2 blockade has shown significantly higher pCR rates and improved tolerability compared to the standard docetaxel plus carboplatin and dual HER2 blockade regimen. These findings could potentially reshape preferences for neoadjuvant therapy in HER2-positive EBC. Patient Characteristics pCR by clinical-pathological variables Abbreviation:Nab-PHP,nanoparticle albumin-bound paclitaxel plus trastuzumab and pertuzumab; TCbHP,docetaxel plus carboplatin ,trastuzumab and pertuzumab; HR,hormone receptor; IHC,immunohistochemistry. *estrogen and/or progesterone receptor positive is classified as hormone receptor positive;estrogen and progesterone receptor negative is classified as hormone receptor negative Adverse events Abbreviation:Nab-PHP,nanoparticle albumin-bound paclitaxel plus trastuzumab and pertuzumab; TCbHP,docetaxel plus carboplatin ,trastuzumab and pertuzumab;ALT,alanine aminotransferase;AST,aspartate transaminase. Citation Format: Zhenzhen Liu, Xiuchun Chen, Jianghua Qiao, Jiao Dechuang, Chengzheng Wang, Xianfu Sun, Zhenduo Lu, Lianfang Li, Chongjian Zhang, Min Yan, Ya Wei, Chen Bo, Yueqing Feng, Miao Deng, Mingde Ma. De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab in HER2-positive early breast cancer (HELEN-006):a randomized,phase 3 trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-27-05.