Donald A. Berry
YOU?
Author Swipe
View article: TIP-10. Update on GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma
TIP-10. Update on GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma Open
BACKGROUND GBM AGILE (Glioblastoma Adaptive, Global, Innovative Learning Environment) is a multi-arm, international, seamless Phase 2/3 response adaptive randomization (RAR) platform trial designed to efficiently identify investigational t…
View article: Decoding Neural Signatures of Semantic Evaluation in Depression and Suicidality.
Decoding Neural Signatures of Semantic Evaluation in Depression and Suicidality. Open
Depression and suicidality profoundly impact cognition and emotion, yet objective neurophysiological biomarkers remain elusive. We investigated the spatiotemporal neural dynamics underlying affective semantic processing in individuals with…
View article: Adaptive Bayesian Clinical Trials: The Past, Present, and Future of Clinical Research
Adaptive Bayesian Clinical Trials: The Past, Present, and Future of Clinical Research Open
Background/Objectives: Decision-analytic Bayesian approaches are ideally suited for designing clinical trials. They have been used increasingly over the last 30 years in developing medical devices and drugs. A prototype trial is a bandit p…
View article: Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer
Pexidartinib and standard neoadjuvant therapy in the adaptively randomized I-SPY2 trial for early breast cancer Open
Purpose We investigated the small-molecule receptor tyrosine kinase-inhibitor of colony-stimulating factor-1 receptor pexidartinib in the stage II/III breast cancer in the I-SPY2 platform trial. Methods I-SPY2 is an adaptive platform trial…
View article: LTBK-02. EVALUATION OF PAXALISIB IN GBM AGILE PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
LTBK-02. EVALUATION OF PAXALISIB IN GBM AGILE PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA Open
GBM AGILE(NCT03970447) is a phase 2/3 Bayesian adaptive registration platform trial testing multiple therapies against a common control. Paxalisib, a PI3K/mTOR inhibitor, is the 3rd arm in the trial to conclude evaluation. METHODS Paxalisi…
View article: Multi-platform biomarkers of response to an immune checkpoint inhibitor in the neoadjuvant I-SPY 2 trial for early-stage breast cancer
Multi-platform biomarkers of response to an immune checkpoint inhibitor in the neoadjuvant I-SPY 2 trial for early-stage breast cancer Open
Only a subset of patients with breast cancer responds to immune checkpoint blockade (ICB). To better understand the underlying mechanisms, we analyze pretreatment biopsies from patients in the I-SPY 2 trial who receive neoadjuvant ICB usin…
View article: CTNI-39. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
CTNI-39. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA Open
BACKGROUND GBM AGILE (Glioblastoma Adaptive, Global, Innovative Learning Environment) is a biomarker based, multi-arm, international, seamless Phase 2/3 platform trial designed to rapidly identify and confirm experimental therapies that im…
View article: Nivolumab in Patients With Advanced or Metastatic Malignancies, Including Rare Cancers: Results of CheckMate 627, an Adaptive Basket Design Clinical Trial
Nivolumab in Patients With Advanced or Metastatic Malignancies, Including Rare Cancers: Results of CheckMate 627, an Adaptive Basket Design Clinical Trial Open
PURPOSE To report on CheckMate 627 (ClinicalTrials.gov identifier: NCT02832167 ), a phase II adaptive basket design trial of nivolumab in uncommon advanced/metastatic tumors. METHODS Adults with previously treated advanced/metastatic malig…
View article: P27.11.A GLOBAL EXPANSION OF GBM AGILE: A PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
P27.11.A GLOBAL EXPANSION OF GBM AGILE: A PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA Open
BACKGROUND GBM AGILE (Glioblastoma Adaptive, Global, Innovative Learning Environment) is a biomarker based, multi-arm, international, seamless Phase 2/3 platform trial designed to continuously add new arms and to rapidly identify experimen…
View article: KS03.5.A EVALUATION OF VAL-083 IN GBM AGILE, A PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA
KS03.5.A EVALUATION OF VAL-083 IN GBM AGILE, A PHASE 3 REGISTRATION PLATFORM TRIAL FOR NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA Open
BACKGROUND GBM AGILE(NCT03970447) is a phase 2/3 Bayesian adaptive registration platform trial testing multiple therapies efficiently against a common control (C) with a primary endpoint of overall survival (OS). VAL-083 (VAL) is a DNA tar…
View article: Pathological response in resectable non–small cell lung cancer: a systematic literature review and meta-analysis
Pathological response in resectable non–small cell lung cancer: a systematic literature review and meta-analysis Open
Background Surrogate endpoints for overall survival in patients with resectable non–small cell lung cancer receiving neoadjuvant therapy are needed to provide earlier treatment outcome indicators and accelerate drug approval. This study’s …
View article: Supplementary Table S3 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S3 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Estimated pCR rates
View article: Supplementary Table S4 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S4 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Trebananib vs Control pCR–Biomarker Associations
View article: Supplementary Table S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Representativeness of Study Participants
View article: Supplementary Table S4 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S4 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Trebananib vs Control pCR–Biomarker Associations
View article: Supplementary Methods S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Methods S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Using Contemporary Controls and Adjusting for Time Trends in I-SPY2: The Time Machine
View article: Supplementary Table S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Representativeness of Study Participants
View article: Supplementary Figure S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Figure S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Kaplan-Meier survival plot of pCR vs. non-pCR in both trebananib and control arms
View article: Data from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Data from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Purpose:The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast …
View article: Supplementary Table S2 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S2 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
RPPA endpoints and genes/signatures involved in TIE2 signaling that were studied
View article: Supplementary Table S2 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S2 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
RPPA endpoints and genes/signatures involved in TIE2 signaling that were studied
View article: Supplementary Figure S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Figure S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Kaplan-Meier survival plot of pCR vs. non-pCR in both trebananib and control arms
View article: Supplementary Table S3 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Table S3 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Estimated pCR rates
View article: Data from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Data from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Purpose:The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast …
View article: Supplementary Methods S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Supplementary Methods S1 from Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Using Contemporary Controls and Adjusting for Time Trends in I-SPY2: The Time Machine
View article: Analysis of Breast Cancer Mortality in the US—1975 to 2019
Analysis of Breast Cancer Mortality in the US—1975 to 2019 Open
Importance Breast cancer mortality in the US declined between 1975 and 2019. The association of changes in metastatic breast cancer treatment with improved breast cancer mortality is unclear. Objective To simulate the relative associations…
View article: Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery
Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial—Efficacy and Biomarker Discovery Open
Purpose: The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast…