Barbara Haley

ORCID: 0000-0001-6106-2676
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About
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Research Areas
  • Breast Cancer Treatment Studies
  • HER2/EGFR in Cancer Research
  • Advanced Breast Cancer Therapies
  • Cancer Genomics and Diagnostics
  • Cancer Treatment and Pharmacology
  • Monoclonal and Polyclonal Antibodies Research
  • Cancer Immunotherapy and Biomarkers
  • Estrogen and related hormone effects
  • Immune cells in cancer
  • Advanced Radiotherapy Techniques
  • BRCA gene mutations in cancer
  • PARP inhibition in cancer therapy
  • Lung Cancer Research Studies
  • Breast Lesions and Carcinomas
  • Lung Cancer Treatments and Mutations
  • Chemotherapy-induced cardiotoxicity and mitigation
  • Cancer Diagnosis and Treatment
  • Nonmelanoma Skin Cancer Studies
  • Cancer survivorship and care
  • Effects of Radiation Exposure
  • Nanoparticle-Based Drug Delivery
  • Cancer Cells and Metastasis
  • Bone health and treatments
  • Immune Cell Function and Interaction
  • Cancer-related Molecular Pathways

The University of Texas Southwestern Medical Center
2015-2025

Southwestern Medical Center
2009-2022

Harold C. Simmons Comprehensive Cancer Center
2005-2021

Dana-Farber Cancer Institute
2017-2018

The Ohio State University
2018

Pennsylvania State University
2018

Albert Einstein College of Medicine
2018

Mayo Clinic
2018

Georgetown University
2018

University of Alabama at Birmingham
2018

Abstract Purpose: The purpose of this study was to test the hypothesis that circulating tumor cells (CTCs) are present in patients many years after mastectomy without evidence disease and these CTCs shed from persisting with breast cancer dormancy. Experimental Design: We searched for 36 dormancy candidate 26 age-matched controls using stringent criteria cytomorphology, immunophenotype, aneusomy. Results: Thirteen candidates, 7 22 clinical disease, had CTCs, usually on more than one...

10.1158/1078-0432.ccr-04-1110 article EN Clinical Cancer Research 2004-12-15

The genetic and clinical heterogeneity of breast cancer makes the identification effective therapies challenging. We designed I-SPY 2, a phase multicenter, adaptively randomized trial to screen multiple experimental regimens in combination with standard neoadjuvant chemotherapy for cancer. goal is match responding subtypes. report results veliparib, poly(ADP-ribose) polymerase (PARP) inhibitor, combined carboplatin.In this ongoing trial, women are eligible participation if they have stage II...

10.1056/nejmoa1513749 article EN New England Journal of Medicine 2016-07-06

Amplification and overexpression of the HER-2 oncogene in breast cancer is felt to be stable over course disease concordant between primary tumor metastases. Therefore, patients with -negative tumors rarely will receive anti-Her-2 antibody (trastuzumab, Herceptin) therapy. A very sensitive blood test was used capture circulating cells (CTCs) evaluate their gene status by fluorescence situ hybridization. The corresponding CTCs 31 showed 97% agreement, no false positives. In 10 -positive...

10.1073/pnas.0402993101 article EN Proceedings of the National Academy of Sciences 2004-06-11

NALA (ClinicalTrials.gov identifier: NCT01808573) is a randomized, active-controlled, phase III trial comparing neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, reversible dual TKI, (L+C) in patients with centrally confirmed HER2-positive, metastatic breast cancer (MBC) ≥ 2 previous HER2-directed MBC regimens.Patients, including those stable, asymptomatic CNS disease, were randomly assigned 1:1 to neratinib (240 mg once every day)...

10.1200/jco.20.00147 article EN cc-by-nc-nd Journal of Clinical Oncology 2020-07-17

The heterogeneity of breast cancer makes identifying effective therapies challenging. I-SPY 2 trial, a multicenter, adaptive phase trial neoadjuvant therapy for high-risk clinical stage II or III cancer, evaluated multiple new agents added to standard chemotherapy assess the effects on rates pathological complete response (i.e., absence residual in lymph nodes at time surgery).We used randomization compare plus tyrosine kinase inhibitor neratinib with control. Eligible women were categorized...

10.1056/nejmoa1513750 article EN New England Journal of Medicine 2016-07-06
Christina Yau Marie Osdoit Marieke van der Noordaa Sonal Shad Jane Wei and 95 more Diane De Croze Anne-Sophie Hamy Marick Laé Fabien Reyal Gabe S. Sonke Tessa G. Steenbruggen Maartje van Seijen Jelle Wesseling Miguel Martín Marı́a del Monte-Millán Sara López‐Tarruella Judy C. Boughey Matthew P. Goetz Tanya L. Hoskin Rebekah Gould Vicente Valero Stephen B. Edge Jean Abraham John M.S. Bartlett Carlos Caldas Janet Dunn Helena Earl Larry Hayward Louise Hiller Elena Provenzano Stephen‐John Sammut Jeremy Thomas David Cameron A Graham Peter Hall Lorna Mackintosh Fang Fan Andrew K. Godwin Kelsey Schwensen Priyanka Sharma Angela DeMichele Kimberly Cole Lajos Pusztai Mi‐Ok Kim Laura van ‘t Veer Laura J. Esserman W. Fraser Symmans Kathi Adamson Kathy S. Albain Adam L. Asare Smita Asare Ronald Balassanian Heather Beckwith Scott Berry Donald A. Berry Judy C. Boughey Meredith Buxton Yunn‐Yi Chen Beiyun Chen A. Jo Chien Jane Yuet Ching Hui Amy S. Clark Julia L. Clennell Brian Datnow Angela DeMichele Xiuzhen Duan Kirsten K. Edmiston Anthony Elias Erin D. Ellis Laura Esserman David Euhus Oluwole Fadare Fang Fan Michael D. Feldman Andres Forero‐Torres Barbara Haley Hyo S. Han Shuko Harada Patricia Haugen Teresa Helsten Gillian L. Hirst Nola M. Hylton Claudine Isaacs Kathleen Kemmer Qamar J. Khan Laila Khazai Molly Klein Gregor Krings Julie E. Lang Lauren LeBeau Brian Leyland‐Jones Minetta C. Liu Shelly S. Lo Janice Lu Anthony M. Magliocco Jeffrey B. Matthews Michelle Melisko Paulette Mhawech‐Fauceglia Stacy L. Moulder Rashmi K. Murthy

BackgroundPrevious studies have independently validated the prognostic relevance of residual cancer burden (RCB) after neoadjuvant chemotherapy. We used results from several independent cohorts in a pooled patient-level analysis to evaluate relationship RCB with long-term prognosis across different phenotypic subtypes breast cancer, assess generalisability broad range practice settings.MethodsIn this analysis, 12 institutes and trials Europe USA were identified by personal communications...

10.1016/s1470-2045(21)00589-1 article EN cc-by-nc-nd The Lancet Oncology 2021-12-11

This study was designed to assess efficacy, safety, and predictors of response iniparib in combination with gemcitabine carboplatin early-stage triple-negative BRCA1/2 mutation-associated breast cancer.This single-arm phase II enrolled patients stage I IIIA (T ≥ 1 cm) estrogen receptor-negative (≤ 5%), progesterone human epidermal growth factor receptor 2-negative or cancer. Neoadjuvant (1,000 mg/m(2) intravenously [IV] on days 8), (area under curve 2 IV (5.6 mg/kg 1, 4, 8, 11) were...

10.1200/jco.2014.57.0085 article EN Journal of Clinical Oncology 2015-04-07

Purpose The mammalian target of rapamycin inhibitor everolimus targets aberrant signaling through the PI3K/AKT/mammalian pathway, a mechanism resistance to anti-estrogen therapy in estrogen receptor (ER)-positive breast cancer. We hypothesized that plus selective ER downregulator fulvestrant would be more efficacious than alone ER-positive metastatic cancer resistant aromatase (AI) therapy. Patients and Methods This randomized, double-blind, placebo-controlled, phase II study included 131...

10.1200/jco.2017.76.9331 article EN Journal of Clinical Oncology 2018-04-17

Zoledronic acid, a potent bisphosphonate, is commonly administered to patients with bone metastases reduce the risk of skeletal-related events (SREs). However, there have been concerns regarding its long-term monthly administration.To examine whether zoledronic acid every 12 weeks was noninferior 4 in metastatic breast cancer that involved who had previously received standard dosing regimen and/or pamidronate disodium.OPTIMIZE-2 prospective, randomized, double-blind, multicenter phase 3...

10.1001/jamaoncol.2016.6316 article EN JAMA Oncology 2017-01-26

BackgroundEstrogen receptor-positive (ER-positive) metastatic breast cancer is often intractable due to endocrine therapy resistance. Although ESR1 promoter switching events have been associated with endocrine-therapy resistance, recurrent fusion proteins yet be identified in advanced cancer.Patients and methodsTo identify genomic structural rearrangements (REs) including gene fusions acquired we undertook a multimodal sequencing effort three patient cohorts: (i) mate-pair and/or RNAseq 6...

10.1093/annonc/mdy025 article EN cc-by-nc Annals of Oncology 2018-01-18

The phosphatidylinositol 3-kinase/Akt/mammalian target of rapamycin is a key pathway survival and therapeutic resistance in breast cancer. We evaluated the pan-Akt inhibitor MK-2206 combination with standard therapy patients high-risk early-stage cancer.I-SPY 2 multicenter, phase II, open-label, adaptively randomized neoadjuvant platform trial that screens experimental therapies efficiently identifies potential predictive biomarker signatures. Patients are categorized by human epidermal...

10.1200/jco.19.01027 article EN Journal of Clinical Oncology 2020-02-07

1000 Background: Pretreated HER2+ MBC lacks a defined standard of care, although T is commonly used. M has similar HER2 binding and antiproliferative effects as T. By contrast, M’s Fc region engineered to increase affinity for both alleles the activating receptor (FcR), CD16A, decrease inhibitory FcR, CD32B. The low CD16A-158F allele (~85% population) been associated with diminished clinical response In Phase 1 trial, demonstrated acceptable safety, anti-tumor activity, evidence...

10.1200/jco.2019.37.15_suppl.1000 article EN Journal of Clinical Oncology 2019-05-20

<h3>Importance</h3> Residual cancer burden (RCB) distributions may improve the interpretation of efficacy in neoadjuvant breast trials. <h3>Objective</h3> To compare RCB between randomized control and investigational treatments within subtypes explore relationship with survival. <h3>Design, Setting, Participants</h3> The I-SPY2 is a multicenter, platform adaptive, clinical trial US that compares, by subtype, agents combination chemotherapy vs alone adult women stage 2/3 at high risk early...

10.1001/jamaoncol.2021.3690 article EN JAMA Oncology 2021-09-16

Neratinib has efficacy in central nervous system (CNS) metastases from HER2-positive metastatic breast cancer (MBC). We report outcomes among patients with CNS at baseline the phase III NALA trial of neratinib plus capecitabine (N + C) versus lapatinib (L C).NALA was a randomized, active-controlled who received two or more previous HER2-directed regimens for MBC. Patients asymptomatic/stable brain (treated untreated) were eligible. assigned to N C (neratinib 240 mg per day, 750 mg/m2 twice...

10.1002/onco.13830 article EN cc-by-nc-nd The Oncologist 2021-05-24

Overexpression of urokinase plasminogen activator system or HER-2 (erbB-2) in breast cancer is associated with a poor prognosis. overexpression caused by gene amplification. The anti-HER-2 antibody trastuzumab significantly improves clinical outcome for HER2-positive cancer. Drugs that target the uPA are early trials. aims this study were to determine whether receptor (uPAR) amplification occurs and analysis individual tumor cells (TCs) blood tissue can add information conventional...

10.1073/pnas.0608113103 article EN Proceedings of the National Academy of Sciences 2006-11-02

This retrospective study of formalin-fixed infiltrating breast cancer specimens compared manual immunohistochemical assay with a new image analyzer–assisted quantitation method, using fluorescence in situ hybridization (FISH) as the standard. Following assay, 189 cases, including most immunohistochemically positive and some random negative were analyzed by FISH for Her-2/neu gene amplification Automated Cellular Imaging System (ACIS) staining. Using standard, ACIS attained higher concordance...

10.1309/tmuw-g4wb-lxj2-fudn article EN American Journal of Clinical Pathology 2001-10-01

To characterize prognostic values of androgen receptor (AR) in triple-negative (TN) breast cancers, we investigated AR expression status and levels, explored an association with metastatic disease, correlated Ki-67 TN invasive carcinomas. was analyzed immunohistochemistry 121 cases tumors. Thirty-nine had distant disease 82 locoregional only. positive 38 (31.4%) the cases. Our results indicate that among AR-positive tumors, metastases are significantly associated lower compared only...

10.1309/ajcp8avf8fdptzlh article EN American Journal of Clinical Pathology 2012-09-24

Abstract The many improvements in breast cancer therapy recent years have so lowered rates of recurrence that it is now difficult or impossible to conduct adequately powered adjuvant clinical trials. Given the new drugs and potential synergistic combinations, neoadjuvant approach has been used test benefit drug combinations trials primary cancer. A FDA-led meta-analysis showed pathologic complete response (pCR) predicts disease-free survival (DFS) within patients who specific subtypes. This...

10.1158/1078-0432.ccr-14-1760 article EN Clinical Cancer Research 2015-02-26

Abstract HER2-targeted therapy dramatically improves outcomes in early breast cancer. Here we report the results of two combinations neoadjuvant I-SPY2 phase 2 adaptive platform trial for cancer at high risk recurrence: ado-trastuzumab emtansine plus pertuzumab (T-DM1/P) and paclitaxel, trastuzumab (THP). Eligible women have &gt;2.5 cm clinical stage II/III HER2 + cancer, adaptively randomized to T-DM1/P, THP, or a common control arm paclitaxel/trastuzumab (TH), followed by...

10.1038/s41467-021-26019-y article EN cc-by Nature Communications 2021-11-05

To evaluate the tolerability of a dose-escalated 5-fraction stereotactic body radiation therapy for partial-breast irradiation (S-PBI) in treating early-stage breast cancer after partial mastectomy; primary objective was to escalate dose utilizing robotic system lumpectomy cavity without exceeding maximum tolerated dose.Eligible patients included those with ductal carcinoma situ or invasive nonlobular epithelial histologies and stage 0, I, II, tumor size <3 cm. Patients physicians completed...

10.1016/j.ijrobp.2017.01.020 article EN cc-by-nc-nd International Journal of Radiation Oncology*Biology*Physics 2017-01-12

Introduction Experts suggest doxorubicin clearance is decreased in women with a body mass index (BMI) of ≥35 kg/m 2 . However, few data support this recommendation. Methods Women receiving for breast cancer three BMI groups were recruited (n = 15). Doxorubicin dosing was determined by surface area and administered 30-min intravenous infusion. Blood samples obtained at 0 h (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 12–24, 24–72 following the beginning Concentrations its metabolite, doxorubicinol,...

10.1177/10781552251326045 article EN Journal of Oncology Pharmacy Practice 2025-03-13

Blocking the function of myeloid-derived suppressor cells (MDSC) is an attractive approach for cancer immunotherapy. Having shown DC-HIL/GPNMB to be T-cell-inhibitory receptor mediating MDSCs, we evaluated potential anti-DC-HIL mAb as MDSC-targeting treatment.

10.1158/1078-0432.ccr-18-0330 article EN Clinical Cancer Research 2018-07-26
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