Autism Detection in Early Childhood (ADEC) in a Low-Income Spanish-Speaking Population in Guayaquil (Ecuador).

Autism Spectrum Disorder (ASD) must be present early in development, but may not fully manifest until social demands exceed capacities. In the absence of adequate biological or brain imaging markers to detect and diagnose autism, diagnosis relies on clinical judgment based on observation of symptoms. Many tools have been developed in English-speaking countries (questionnaires for parents, symptom checklists for professionals, observation systems, etc.). Screening in countries with other languages requires cultural and linguistic adaptation of these instruments. This paper presents the adaptation of the ADEC (Autism Detection in Early Childhood). METHODS: The original version of the ADEC was translated and culturally and linguistically adapted to the characteristics of the population of Guayaquil (Ecuador). PARTICIPANTS: A pilot study was conducted with a sample of 613 children aged 18-48 months. RESULTS: Cronbach's alpha values (0.89) indicate high internal consistency. The correlation between the MCHAT-R/F follow-up interview and the ADEC (mean r = 0.93) indicates high construct validity. In terms of predictive validity, using the original cut-off points of the ADEC, they show excellent diagnostic ability. The sensitivity and specificity results (sensitivity 1.00; specificity 0.92; positive predictive value 0.83; negative predictive value 0.99) are even better than those obtained in a similar study in the Mexican population. CONCLUSIONS: Considering that the MCHAT R/F is a parent-reported instrument, the Guayaquil Spanish version of the ADEC (ADEC-GU) seems to be a suitable instrument to be used in a complementary way as a second-level screening instrument for autism, before resorting to a full diagnostic process.

A comparison of the presentations of males and females with autism spectrum disorder and those narrowly below the diagnostic threshold.

LAY ABSTRACT: Most research about autism spectrum disorder (ASD) in females has looked at autistic features in people who have already received diagnoses. Because our understanding of ASD has been shaped by the difficulties of males, females may experience different difficulties and may not meet the criteria for diagnosis because of a skewed concept of ASD. We extracted detailed information from the assessment reports of 222 children who were either diagnosed with ASD (156 children) or not diagnosed despite many ASD traits (78 children). Females were less likely to have restricted interests, especially females who did not receive an ASD diagnosis. Females who did not receive an ASD diagnosis tended to show more ability in social and emotional reciprocity than what would qualify them for a diagnosis. We also found sex-/gender-specific profiles of body use and speech mannerisms. Many behaviours were more closely linked with an ASD diagnosis for males and others for females, suggesting that behaviours may be interpreted differently depending on the child's sex/gender. We discuss implications for assessing females for ASD in the context of this evidence.

Autistic adults' perspectives on appropriate empathic responses to others' emotions.

Although the ability of autistic adults to recognize others' emotions has been extensively studied, less attention has been given to how they respond to these emotions. We examined two aspects of autistic and non-autistic adults' responsiveness to the emotional expressions of non-autistic actors: their perspectives on the appropriate way of responding to others' emotions and their awareness of others' perceptions of the likely appropriateness of such responses. Autistic (N = 63) and non-autistic (N = 67) adult samples viewed videos of 74 dyadic social interactions displaying different examples of 12 emotions expressed by one actor in response to the behavior of the other. After each video, participants (a) nominated the emotion expressed by the first actor, (b) offered their perspective on what would constitute an appropriate empathic response by the second actor, and (c) indicated their confidence in that response. Although the autistic group provided fewer appropriate empathic responses-operationalized via a panel's interpretations of normative responses-than the non-autistic group, within-group variability was marked, and the effect was weak and largely confined to basic emotions. Autistic individuals were, however, considerably less confident in their responses. Examination of the relationships between confidence in and the appropriateness of empathic responses provided no indication in either group of reliable discrimination of appropriate from inappropriate empathic responses or finely tuned metacognitive awareness of variations in appropriateness. In sum, autistic adults' perspectives on the appropriate empathic reactions to non-autistic adults' emotions were not unilaterally or markedly different to those of non-autistic adults.

Response format changes the reading the mind in the eyes test performance of autistic and non-autistic adults.

LAY ABSTRACT: Recognizing and understanding the perspectives of others-also called theory of mind-is important for effective communication. Studies have found that some autistic individuals have greater difficulty with theory of mind compared to non-autistic individuals. One purported theory of mind measure is the Reading the Mind in the Eyes Test (RMET). This test presents participants with photographs of pairs of eyes and asks them to identify the emotion displayed by each pair of eyes from four choices. Some researchers have argued that the multiple-choice format of the RMET may not be an accurate measure of theory of mind, as participants could simply be guessing or using a process of elimination to select the correct answer. Participants may also be disadvantaged if they are not familiar with the specific emotion words used in the multiple-choice answers. We examined whether a free-report (open-ended) format RMET would be a more valid measure of theory of mind than the multiple-choice RMET. Autistic and non-autistic adults performed better on the multiple-choice RMET than the free-report RMET. However, both versions successfully differentiated autistic and non-autistic adults, irrespective of their level of verbal ability. Performance on both versions was also correlated with another well-validated adult measure of theory of mind. Thus, the RMET's multiple-choice format does not, of itself, appear to underpin its ability to differentiate autistic and non-autistic adults.

Revisiting the Relationship between Cybercrime, Autistic Traits, and Autism.

Reports of cybercrime being committed by people on the autism spectrum often imply that autism may be more prevalent among cybercriminals than the general population, although this remains unproven. In an online survey of 302 participants, we found that autistic individuals (n = 25) were more likely to report engagement in cybercrime than non-autistic individuals, but this relationship was not mediated by advanced digital skills or deficits in theory of mind. Furthermore, independent of autism diagnosis, autistic traits were not significantly associated with self-reported cyber-criminality. We propose that there may be additional factors moderating the relationship between autism, autistic traits, and cybercrime, such as specific autistic characteristics, understanding of cybercrime, and willingness to disclose criminal activity.

Detecting dodgy behaviour: The role of autism, autistic traits and theory of mind.

LAY ABSTRACT: Difficulties in reading others' minds make it difficult to anticipate their future behaviour. It has often been argued that such difficulties contribute to autistic individuals becoming enmeshed in criminal activity. However, supportive scientific evidence is virtually non-existent. We compared the ability of groups of autistic and non-autistic adults of similar intellectual ability to detect dodgy or suspicious behaviour across a wide range of scenarios. Although the autistic group performed more poorly than the non-autistic group on an established measure of mindreading, there were no group differences in the ability to detect dodginess. Nor did we find any evidence that detecting dodgy behaviour was associated with the degree of autistic traits reported by individual participants. However, when we combined the two groups, difficulty reading the minds of others was indeed associated with poorer detection of dodginess, thus highlighting a characteristic of individuals that may well increase the likelihood of becoming involved in crime or exploited for autistic and non-autistic individuals alike.

Facing up to others' emotions: No evidence of autism-related deficits in metacognitive awareness of emotion recognition.

Emotion recognition difficulties are considered to contribute to social-communicative problems for autistic individuals and awareness of such difficulties may be critical for the identification and pursuit of strategies that will mitigate their adverse effects. We examined metacognitive awareness of face emotion recognition responses in autistic (N = 63) and non-autistic (N = 67) adults across (a) static, dynamic and social face emotion stimuli, (b) free- and forced-report response formats, and (c) four different sets of the six "basic" and six "complex" emotions. Within-individual relationships between recognition accuracy and post-recognition confidence provided no indication that autistic individuals were poorer at discriminating correct from incorrect recognition responses than non-autistic individuals, although both groups exhibited marked inter-individual variability. Although the autistic group was less accurate and slower to recognize emotions, confidence-accuracy calibration analyses provided no evidence of reduced sensitivity on their part to fluctuations in their emotion recognition performance. Across variations in stimulus type, response format and emotion, increases in accuracy were associated with progressively higher confidence, with similar calibration curves for both groups. Calibration curves for both groups were, however, characterized by overconfidence at the higher confidence levels (i.e., overall accuracy less than the average confidence level), with the non-autistic group contributing more decisions with 90%-100% confidence. Comparisons of slow and fast responders provided no evidence of a "hard-easy" effect-the tendency to exhibit overconfidence during hard tasks and underconfidence during easy tasks-suggesting that autistic individuals' slower recognition responding may reflect a strategic difference rather than a processing speed limitation. LAY SUMMARY: It is generally considered that autistic individuals may have difficulty recognizing other people's facial emotions. However, little is known about their awareness of any emotion recognition difficulties they may experience. This study indicates that, although there is considerable individual variability, autistic adults were as sensitive to variations in the accuracy of their recognition of others' emotions as their non-autistic peers.

Speed and accuracy of emotion recognition in autistic adults: The role of stimulus type, response format, and emotion.

Emotion recognition difficulties are considered to contribute to social-communicative problems for autistic individuals. Prior research has been dominated by a focus on forced-choice recognition response accuracy for static face presentations of basic emotions, often involving small samples. Using free-report and multiple-choice response formats, we compared emotion recognition in IQ-matched autistic (N = 63) and nonautistic (N = 67) adult samples using 12 face emotion stimuli presented in three different stimulus formats (static, dynamic, social) that varied the degree of accompanying contextual information. Percent agreement with normative recognition responses (usually labeled "recognition accuracy") was slightly lower for autistic adults. Both groups displayed marked inter-individual variability and, although there was considerable overlap between groups, a very small subset of autistic individuals recorded lower percent agreement than any of the nonautistic sample. Overall, autistic individuals were significantly slower to respond and less confident. Although stimulus type, response format, and emotion affected percent agreement, latency and confidence, their interactions with group were nonsignificant and the associated effect sizes extremely small. The findings challenge notions that autistic adults have core deficits in emotion recognition and are more likely than nonautistic adults to be overwhelmed by increasingly dynamic or complex emotion stimuli and to experience difficulties recognizing specific emotions. Suggested research priorities include clarifying whether longer recognition latencies reflect fundamental processing limitations or adjustable strategic influences, probing age-related changes in emotion recognition across adulthood, and identifying the links between difficulties highlighted by traditional emotion recognition paradigms and real-world social functioning. LAY SUMMARY: It is generally considered that autistic individuals are less accurate than nonautistic individuals at recognizing other people's facial emotions. Using a wide array of emotions presented in various contexts, this study suggests that autistic individuals are, on average, only slightly less accurate but at the same time somewhat slower when classifying others' emotions. However, there was considerable overlap between the two groups, and great variability between individuals. The differences between groups prevailed regardless of how stimuli were presented, the response required or the particular emotion.

Preliminary Validation and Feasibility of the Autism Detection in Early Childhood-Virtual (ADEC-V) for Autism Telehealth Evaluations in a Hospital Setting.

This study provided preliminary validation of the Autism Detection in Early Childhood-Virtual (ADEC-V) for telehealth assessment of possible autism. Participants were 121 children (24.79% female) aged 18-47 months who completed telehealth evaluations at a large pediatric hospital in the Midwestern United States between October 2020 and February 2021. The ADEC-V showed good sensitivity (0.82) and specificity (0.78) and was significantly correlated with other ASD symptom measures (i.e., CARS-2, ADI-R). Internal consistency was acceptable (α = 0.77). These results need replication in a larger and broader sample including more children without ASD. This preliminary validation study identifies the ADEC-V as a promising measure for telehealth ASD assessments in young children.

Autistic Adults May Be Erroneously Perceived as Deceptive and Lacking Credibility.

We hypothesized that autistic adults may be erroneously judged as deceptive or lacking credibility due to demonstrating unexpected and atypical behaviors. Thirty autistic and 29 neurotypical individuals participated in video-recorded interviews, and we measured their demonstration of gaze aversion, repetitive body movements, literal interpretation of figurative language, poor reciprocity, and flat affect. Participants (N = 1410) viewed one of these videos and rated their perception of the individual's truthfulness or credibility. The hypothesis was partially supported, with autistic individuals perceived as more deceptive and less credible than neurotypical individuals when telling the truth. However, this relationship was not influenced by the presence of any of the target behaviors, but instead, by the individual's overall presentation.

A Mixed-Methods Investigation of Diagnostician Sex/Gender-Bias and Challenges in Assessing Females for Autism Spectrum Disorder.

Despite the importance of clinical judgement in autism spectrum disorder (ASD) assessment, little is currently known about challenges faced by diagnosticians when the client is female, any sex/gender biases during the assessment process, and how these issues affect diagnostic outcomes. Forty-seven ASD diagnosticians completed a questionnaire containing two hypothetical case studies (a 'male' and 'female' ASD presentation), with sex/gender randomly assigned within each. Diagnosticians reported greater ASD symptom severity when female sex/gender pseudonyms were allocated to the case studies, but their confidence in ASD diagnosis was similar regardless of condition. Diagnosticians identified a large number of challenges associated with assessing females for ASD. Many of these related to sex/gender differences in ASD presentation and limitations of diagnostic instruments.

Sex/Gender Differences in CARS2 and GARS-3 Item Scores: Evidence of Phenotypic Differences Between Males and Females with ASD.

Growing evidence suggests that autistic females are more likely to be diagnostically overlooked than males, perhaps due to differences in ASD presentations (van Wijngaarden-Cremers in JAMA 44:627-635, 2014). To investigate specific behaviours in which differences lie, we analysed profiles of 777 children using the Childhood Autism Rating Scale (Scholper in JAMA 29:489-493, 2010) or Gilliam Autism Rating Scale (Gilliam, 2014). Males demonstrated greater difficulty in six CARS2-ST items and seven behaviours on the GARS-3, mostly reflecting restricted and repetitive behaviours. Across all instruments, the only area in which females showed greater difficulty was fear or nervousness (CARS2-ST). No meaningful differences emerged from the CARS2-HF analysis. Where males showed greater difficulty, females were more likely to present with developmentally typical behaviour.

Brief Report: Sentencing Outcomes for Offenders on the Autism Spectrum.

Although people diagnosed with autism spectrum disorder (ASD) are not more likely to commit crimes, they are overrepresented in the criminal justice system as reported by Howlin (Autism and Asperger syndrome: Preparing for adulthood, Routledge, 2004). This may, in part, be due to unfavourable interactions with the criminal judiciary. Evidence suggests the autistic population are perceived unfavourably in adjudicative proceedings resulting in harsher penalties. The present study explores whether ASD offenders (ASD-O) receive longer sentences compared to national sentencing data. Sentencing data from the Australian Bureau of Statistics (ABS) were used to compare ASD-O with similar offences. ASD-O attracted longer sentences across all offence classifications. Inferential analyses indicated sexual assault sentences were significantly higher in the ASD-O sample. No significant differences were found for murder, manslaughter, and assault.

A Quick Measure of Theory of Mind in Autistic Adults: Decision Accuracy, Latency and Self-Awareness.

Autistic adults often experience difficulties in taking the perspective of others, potentially undermining their social interactions. We evaluated a quick, forced-choice version of the Adult Theory of Mind (A-ToM) test, which was designed to assess such difficulties and comprehensively evaluated by Brewer et al. (2017). The forced-choice version (the A-ToM-Q) demonstrated discriminant, concurrent, convergent and divergent validity using samples of autistic (N = 96) and non-autistic adults (N = 75). It can be administered in a few minutes and machine-scored, involves minimal training and facilitates large-scale, live, or web-based testing. It permits measurement of response latency and self-awareness, with response characteristics on both measures enhancing understanding of the nature and extent of perspective taking difficulties in autistic individuals.

A Phase II Study Evaluating Orteronel, an Inhibitor of Androgen Biosynthesis, in Patients With Androgen Receptor (AR)-Expressing Metastatic Breast Cancer (MBC).

BACKGROUND: AR is a targetable pathway with AR modulation inhibiting estrogen- and androgen-mediated cell proliferation. Orteronel is an oral, selective, nonsteroidal inhibitor of 17, 20-lyase, a key enzyme in androgen biosynthesis. This study evaluated single-agent orteronel in AR+ metastatic breast cancer (MBC). METHODS: Male/female patients with AR+ MBC were grouped in Cohort 1: AR+ TNBC with l-3 prior chemotherapy regimens or Cohort 2: AR+ HR+ (estrogen [ER+]/ progesterone receptor [PR+] positive) HER2+/- with 1 to 3 prior hormonal and at least 1 prior chemotherapy regimen. Patients with HER2+ MBC must have received at least 2 lines of HER2-targeted therapy. Orteronel was administered at 300 mg BID; response rate was the primary endpoint. RESULTS: Seventy patients were enrolled (Cohort 1, n = 26 and Cohort 2, n = 44). Median treatment duration was 7.1 weeks. Seven patients were on treatment for ≥6 months. One of the 21 evaluated patients in Cohort 1 (4.8%) had an objective response. In Cohort 2, none of the first 23 patients to be evaluated had a response and accrual was stopped. Median progression-free and overall survival were 1.8 and 8.3 months, respectively. Toxicities were predominantly Grade 1 or 2 nausea/vomiting (36%) and fatigue (31%). Grade 3 or 4 events in ≥5% of patients included increased amylase/lipase (10%) and hypertension (6%). CONCLUSIONS: Orteronel demonstrated limited clinical activity in heavily pre-treated AR+ MBC. Further development of orteronel in MBC is not recommended. Further efforts to validate the AR as a therapeutic target should focus on identifying new markers predictive of sensitivity to AR-targeted agents.

The efficacy and safety of enzalutamide with trastuzumab in patients with HER2+ and androgen receptor-positive metastatic or locally advanced breast cancer.

PURPOSE: Androgen receptor (AR) expression occurs in up to 86% of human epidermal growth factor receptor 2-positive (HER2+) breast cancers. In vitro, AR inhibitors enhance antitumor activity of trastuzumab, an anti-HER2 antibody, in trastuzumab-resistant HER2+ cell lines. This open-label, single-arm, phase II study evaluated the efficacy and safety of enzalutamide, an AR-signaling inhibitor, in patients with advanced HER2+ AR+ breast cancer previously treated with trastuzumab. METHODS: Eligible patients had measurable or non-measurable evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Eastern Cooperative Oncology Group status ≤ 1, no history of brain metastases, and previously received ≥ 1 anti-HER2 regimen for advanced disease. Patients received 160 mg oral enzalutamide daily and 6 mg/kg intravenous trastuzumab every 21 days until disease progression or unacceptable toxicity. Primary end point was clinical benefit rate at 24 weeks (CBR24); secondary end points included progression-free survival (PFS) and safety. RESULTS: Overall, 103 women were enrolled [median age 60 years (range 34-83)]; 62% had received ≥ 3 lines of prior anti-HER2 therapy. CBR24, comprising patients with confirmed partial responses (5%) and durable stable disease at 24 weeks (19%), was 24% in the efficacy evaluable set (n = 89). CBR24 did not seem related to AR-expression levels or hormone receptor status. Median PFS was 3.4 months (95% confidence interval 2.0-3.8). Overall, 97 (94%) patients experienced treatment-emergent adverse events (TEAEs), with fatigue most common (34%). Dyspnea (4%) and malignant neoplasm progression (3%) were the only TEAEs grade ≥ 3 reported in ≥ 3 patients. 22 patients (21%) reported serious TEAEs. Four patients (4%) experienced fatal, non-drug-related TEAEs. CONCLUSIONS: Enzalutamide plus trastuzumab was well tolerated, and a subset of patients in this heavily pretreated population had durable disease control. Determination of biomarkers is needed to identify patients most likely to benefit from this combination. CLINICALTRIALS. GOV NUMBER: NCT02091960.

Early implementation of screening for substance use in rural primary care: A rapid analytic qualitative study.

Background: Few primary care patients are screened for substance use. As part of a phased feasibility study examining the implementation of electronic health record-integrated screening with the Tobacco, Alcohol, and Prescription Medication Screening (TAPS) Tool and clinical decision support (CDS) in rural primary care clinics, focus groups were conducted to identify early indicators of success and challenges to screening implementation. Method: Focus groups (n = 6) were conducted with medical assistants (MAs: n = 3: 19 participants) and primary care providers (PCPs: n = 3: 13 participants) approximately one month following screening implementation in three Federally Qualified Health Centers in Maine. Rapid analysis and matrix analysis using Proctor's Taxonomy of Implementation Outcomes were used to explore implementation outcomes. Results: There was consensus that screening is being used, but use of the CDS was lower, in part due to limited positive screens. Fidelity was high among MAs, though discomfort with the CDS surfaced among PCPs, impacting adoption and fidelity. The TAPS Tool's content, credibility and ease of workflow integration were favorably assessed. Challenges include screening solely at annual visits and self-administered screening for certain patients. Conclusions: Results reveal indicators of implementation success and strategies to address challenges to screening for substance use in primary care.

Sleep duration and mood in adolescents: an experimental study.

STUDY OBJECTIVES: This study examines the relationship between experimentally manipulated sleep duration and mood in adolescents. METHODS: Thirty-four adolescents (20 male), aged 15-17 years, lived in a sleep laboratory for 10 days and 9 nights. They were allocated to one of three sleep "doses" for five consecutive nights for 5, 7.5, or 10 h sleep opportunity per night. Two baseline nights and two recovery nights entailed 10 h sleep opportunity per night. Mood was measured every 3 h during wake using unipolar visual analogue scales measuring the mood states "depressed," "afraid," "angry," "confused," "anxious," "happy," and "energetic." RESULTS: Mixed models analyses with post hoc comparisons revealed that participants in the 5-h group, but not the 7.5- or 10-h groups, reported being significantly more depressed, angry, and confused during sleep restriction than at baseline. Adolescents were significantly less happy and energetic during sleep restricted to 5 h and significantly less energetic during sleep restricted to 7.5 h. When adolescents had 10 h sleep opportunities their happiness significantly increased. No statistically significant effects of sleep restriction were found for fear or anxiety, although small-to-moderate effects of sleep restricted to 5 or 7.5 h were found. Two nights of recovery sleep was not sufficient to recover from increased negative mood states for the 5-h group, although recovery occurred for positive mood states. CONCLUSIONS: Given the prevalence of insufficient sleep and the rising incidence of mood disorders and dysregulation in adolescents, these findings highlight the importance of sufficient sleep to mitigate these risks.

Autism Screening in Early Childhood: Discriminating Autism From Other Developmental Concerns.

Early identification of autism, followed by appropriate intervention, has the potential to improve outcomes for autistic individuals. Numerous screening instruments have been developed for children under 3 years of age. Level 1 screeners are used in large-scale screening to detect at-risk children in the general population; Level 2 screeners are concerned with distinguishing children with signs of autism from those with other developmental problems. The focus here is evaluation of Level 2 screeners. However, given the contributions of Level 1 screeners and the necessity to understand how they might interface with Level 2 screeners, we briefly review Level 1 screeners and consider instrument characteristics and system variables that may constrain their effectiveness. The examination of Level 2 screeners focuses on five instruments associated with published evaluations in peer-reviewed journals. Key criteria encompass the traditional indices of test integrity such as test reliability (inter-rater, test-retest) and construct validity, including concurrent and predictive validity, sensitivity (SE), and specificity (SP). These evaluations reveal limitations, including inadequate sample sizes, reliability issues, and limited involvement of independent researchers. Also lacking are comparative test evaluations under standardized conditions, hindering interpretation of differences in discriminative performance across instruments. Practical considerations constraining the use of such instruments-such as the requirements for training in test administration and test administration time-are canvassed. Published Level 2 screener short forms are reviewed and, as a consequence of that evaluation, future directions for assessing the discriminative capacity of items and measures are suggested. Suggested priorities for future research include targeting large and diverse samples to permit robust appraisals of Level 2 items and scales across the 12-36 month age range, a greater focus on precise operationalization of items and response coding to enhance reliability, ongoing exploration of potentially discriminating items at the younger end of the targeted age range, and trying to unravel the complexities of developmental trajectories in autistic infants. Finally, we emphasize the importance of understanding how screening efficacy is dependent on clinicians' and researchers' ability not only to develop screening tests but also to negotiate the complex organizational systems within which screening procedures must be implemented.

Phase II trial of eribulin in patients who do not achieve pathologic complete response (pCR) following neoadjuvant chemotherapy.

PURPOSE: Women with residual invasive breast cancer at the primary site or axillary lymph nodes following neoadjuvant chemotherapy have a high risk of recurrence. Eribulin improves survival in patients with metastatic breast cancer who progress after anthracycline and taxane therapy. This phase 2 trial assessed the efficacy of postoperative eribulin in breast cancer patients who did not achieve a pCR following standard neoadjuvant chemotherapy. METHODS: Women with localized breast cancer who had residual invasive cancer following ≥ 4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy received adjuvant eribulin treatment. HER2-positive patients also received trastuzumab for 1 year. Adjuvant hormonal therapy and locoregional radiotherapy were administered as per institutional guidelines. Primary endpoint was the 2-year DFS rate. Three patient cohorts were analyzed: TNBC (Cohort A), HR+/HER2- (Cohort B), and HER2+ (Cohort C). RESULTS: One hundred twenty-six patients (Cohort A-53, Cohort B-42, and Cohort C-31) were enrolled. Neoadjuvant chemotherapy included a taxane and an anthracycline in 70%. Eribulin was well tolerated; 84% of patients received the planned 6 cycles. After a median follow-up of 28 months, the 24-month DFS rates were 56% (95% CI 42, 69), 83% (95% CI 67, 91), and 73% (95% CI 53, 86) for Cohorts A, B, and C, respectively. The most common grade 3/4 treatment-related adverse events were neutropenia (26%), leukopenia (13%), and neuropathy (7%). CONCLUSION: Administration of adjuvant eribulin after neoadjuvant chemotherapy was feasible and well tolerated. The 24-month DFS rate did not reach the study target levels in any of the cohorts and was similar to DFS previously described in these cohorts following neoadjuvant chemotherapy alone.