Research Projects & Grants

Federal

  • CALGB-40502: A randomized phase III trial of weekly paclitaxel compared to weekly nanoparticle albumin bound NAB-paclitaxel or ixabepilone with or without bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer, Role: PI, National Cancer Institute/NIH/DHHS, (07/2016 - 07/2017) Status: Completed

For Profit Organization

  • Southwest Oncology Group (SWOG) Protocol N063D/BIG2-06-ALTTO - Adjuvant lapatinib and/or trastuzumab treatment optimisation study. A randomized, multi-center, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer, Role: PI, Southwest Oncology Group, (06/2023 - 05/2024) Status: Approved
  • SWOG-S0500 - A randomized phase III trial to test the strategy of changing therapy versus maintaining therapy for metastatic breast cancer patients who have elevated circulating tumor cell (CTC) levels at first follow-up assessment, Role: PI, Southwest Oncology Group, (09/2014 - 09/2015) Status: Completed
  • D926XC00001: A Phase 3 Open-label, Randomized Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Duravalumab Versus Investigator's Choice of Therapy in Patients With Stage 1-111 Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (D926X C00001), Role: PI, AstraZeneca Pharmaceuticals, L.P. (USA), (01/2024 - 01/2025) Status: Approved
  • J2J-MC-JZLH EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence, Role: PI, Eli Lilly & Co., (07/2023 - 07/2024) Status: Approved
  • SDX-0103: A Phase 1/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with the PI3Ka Inhibitor Alpelisib (PIQRAY®) plus Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia with Advanced Breast Cancer and a PIK3CA Mutation Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor, Role: PI, SynDevRx, Inc., (02/2024 - 02/2025) Status: Approved
  • LUNGMAP, “A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Preciously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)” S1900F, “A Randomized Phase II Study of Carboplatin and Pemetrexed with or Without Selpercatinib (LY3527723) in Participants with Non-Squamous RET Fusion-Positive Stage IV Non-Small Cell Lung Cancer and Progression of Disease on Prior RET Directed Therapy (Lung-MAP Sub-Study)”, Role: Investigator, Southwest Oncology Group, Status: Completed
  • MNA-3521-014: An Open Label, Randomized Phase 2 Study to Evaluate the Safety and Efficacy of MTL-CEBPA Administered in Combination With Sorafenib or Sorafenib Alone in TKI naïve Participants With Previously Treated Advanced Hepatocellular Carcinoma (HCC) and Hepatitis B or Hepatitis C Virus (OUTREACH2), Role: Regulatory Coordinator, MINA ALPHA LIMITED, (06/2023 - 06/2024) Status: Approved
  • Amgen Inc., 20190135: A Phase 1b Study Evaluating the Safety, Tolerability, and Efficacy of AMG 510 (plNN Sotorasib) in Combination with Panitumumab and in Combination with Panitumumab and FOLFIRI in Subjects with Advanced Solid Tumors with KRAS p.G12C Mutation (CodeBreak 101 Subprotocol H), Role: Investigator, Amgen, Inc., (06/2023 - 06/2024) Status: Approved
  • Amgen 20190135: A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation Amgen 20190135-C: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Combination With RMC-4630 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101 Subprotocol C), Role: Investigator, Amgen, Inc., (02/2024 - 02/2025) Status: Approved
  • Merck Sharp & Dohme Corp. MK-7339-013: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib (MK-7339), Compared to Concurrent Chemoradiation Therapy Alone in Participants with Newly Diagnosed Treatment- Naïve limited-Stage Small Cell Lung Cancer (LS-SCLC), Role: Investigator, Merck, Sharp & Dohme Corp., (02/2024 - 02/2025) Status: Approved
  • Apollomics Inc. APL-101-01 (SPARTA): Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors, Role: Investigator, Apollomics Inc., (09/2023 - 09/2024) Status: Approved
  • Amgen 20190135: A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (plNN Sotorasib) in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation, Role: Investigator, Amgen, Inc., (03/2024 - 03/2025) Status: Approved
  • ATARA Biotherapeutics, Inc. ATA129-EBV-302: Multicenter, Open Label, Phase 3 study of Tabelecleucel for solid organ or allogeneic hematopoietic cell transplant subjects with Epstein-Barr virus-associated post-transplant lymphoproliferative disease after failure of Rituximab or Rituximab and Chemotherapy (ALLELE study), Role: Investigator, Atara Biotherapeutics, Inc., (01/2024 - 01/2025) Status: Approved
  • SWOG A041701: A randomized phase II/III study of conventional chemotherapy +/- uproleselan (GMI-1271) in older adults with acute Myeloid Leukemia receiving intensive induction chemotherapy, Role: Investigator, Southwest Oncology Group, Status: Completed
  • C3441021: A Phase 3, Randomized, Double-Blind, Placebo-Controlled study of Talazoparib with Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (TALAPRO-2), Role: Investigator, Pfizer Inc., U.S. Pharmaceuticals Group, (07/2021 - 07/2022) Status: Completed
  • SWOG/NRG LU003: A Biomarker-Driven protocol for previously treated ALK-Positive Non-Squamous NSCLC patients: The NCI-NRG ALK protocol, Role: Investigator, Southwest Oncology Group, Status: Completed
  • Novartis CLDK378A2X01B: An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with ceritinib, Role: Investigator, Novartis Pharmaceuticals Corporation, (01/2023 - 01/2024) Status: Completed
  • Novartis CACZ885V2301: A randomized, double-blind, placebo-controlled, phase III study evaluating the efficacy and safety of canakinumab in combination with docetaxel versus placebo in combination with docetaxel in subjects with non-small cell lung cancer (NSCLC) previously treated with PD(L)1 inhibitors and platinum-based chemotherapy (CANOPY-2), Role: Investigator, Novartis Pharmaceuticals Corporation, (09/2020 - 09/2021) Status: Completed
  • Soligenix Inc. IDR-OM-02: A pivotal, double-blind, randomized, placebo-controlled multi-national study of SGX942 (Dusquetide) for treatment of oral mucositis in patients being treated with concomitant Chemoradiation for the treatment of squamous cell carcinoma of the head and neck, Role: Investigator, Soligenix, Inc., (07/2023 - 07/2024) Status: Approved
  • Astellas 8951-CL-0301: A phase 3, global, multi-center, double-blind, randomized, efficacy study of Zolbetuximab plus mFOLFOX6 compared with placebo plus mFOLFOX6 as first-line treatment of subjects with Claudin (CLDN) 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, Role: Investigator, Astellas Pharma US, Inc., (06/2022 - 06/2023) Status: Completed
  • SWOG / NRG-GY009: A Randomized, Phase II/III Study of Pegylated Lipsomal Doxorubicin and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer, Role: Investigator, Southwest Oncology Group, (12/2019) Status: Completed
  • SWOG S1418/BR006: A randomized phase III trial to evaluate the efficacy and safety of MK-3457 (Pembrolizumab) as adjuvant therapy for triple receptor-negative breast cancer with = 1 cm residual invasive cancer or positive lymph nodes (ypN+) after neoadjuvant chemotherapy, Role: PI, Southwest Oncology Group, (02/2024 - 02/2025) Status: Approved
  • Janssen Research & Development, LLC 54767414LUC2001: A phase 1b/2, open-label, randomized study of daratumumab administered in combination with atezolizumab compared with atezolizumab alone in subjects with previously treated advanced or metastatic non-small cell lung cancer, Role: Investigator, Janssen Research & Development, LLC, (05/2018 - 05/2019) Status: Completed
  • Southwest Oncology Group (SWOG) S1609: DART: Dual Anti-CTLA-4 and Anti-PD-1 blockade in rare tumors, Role: Investigator, Southwest Oncology Group, (01/2024 - 01/2025) Status: Approved
  • SWOG: A221101: A phase III randomized, double-blind placebo controlled study of armodafinil (Nuvigil®) to reduce cancer-related fatigue in patients with high grade glioma, Role: Investigator, Southwest Oncology Group, (05/2019 - 05/2020) Status: Completed
  • Merck Sharp & Dohme Corp., MK3475-361: Phase III randomized controlled trial of pembrolizumab with or without chemo vs chemo in advanced urothelial carcinoma, Role: Investigator, Merck, (01/2023 - 01/2024) Status: Completed
  • Midostaurin (PKC412) Individual Patient Program (IPP) for an individual patient 18 years of age and older with newly-diagnosed FLT3-mutated AML and eligible for standard induction and consolidation chemotherapy, Role: Investigator, Novartis Pharmaceuticals Corporation, (01/2017 - 01/2018) Status: Completed
  • Taiho Oncology Inc. TO-TAS-114-201: A randomized, open-label, multi-center, international phase 2 study of TAS-114 in combination with S-1 in patients with advanced or metastatic non-small cell lung cancer, Role: Investigator, Taiho Oncology Inc., (10/2017 - 10/2018) Status: Completed
  • SWOG -EAY131: Molecular analysis for therapy choice (MATCH), Role: PI, Southwest Oncology Group, (08/2019 - 08/2020) Status: Completed
  • SWOG S1507: A phase II trial of Trametinib with Docetaxel in patients with KRAS mutation positive non-small cell lung cancer (NSCLC) and progressive disease following one or two prior systematic therapies, Role: Investigator, Southwest Oncology Group, (05/2023 - 05/2024) Status: Completed
  • Astellas Pharma Global Development, Inc. 8273-CL-0302: An open-label, randomized phase 3 efficacy study of ASP8273 vs. erlotinib or gefitinib in first-line treatment of patients with stage IIIB/IV non-small cell lung cancer tumors with EGFR activating mutations (SOLAR study), Role: Investigator, Astellas Pharma US, Inc., (06/2017 - 06/2018) Status: Completed
  • SWOG EA5142:adjuvant nivolumab in resected lung cancers (ANVIL) a randomized phase III study of nivolumab after surgical resection and adjuvant chemotherapy in non-small cell lung cancers, Role: Investigator, Southwest Oncology Group, (01/2024 - 01/2025) Status: Approved
  • Mirati Therapeutics,Inc., 265-109: Phase 2, parallel-arm study of MGCD265 in patients with locally advanced or metastatic non-small cell lung cancer with activating genetic alterations in mesenchymal-epithelial transition factor, Role: Investigator, Mirati Therapeutics, (10/2017 - 10/2018) Status: Completed
  • SWOG S1318: A phase II study of Blinatumomab (NSC-765986) and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for patients >= 65 years of age with newly diagnosed Philadelphia-chromosome negative acute lymphoblastic leukemia (ALL) and of Dasatinib (NSC-732517), Prednisone and Blinatumomab for patients >= 65 years of age with newly diagnosed Philadelphia-chromosome positive (Ph+) ALL, Role: Investigator, Southwest Oncology Group, (08/2018 - 08/2019) Status: Completed
  • SWOG S1314: A randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer, Role: Investigator, Southwest Oncology Group, (04/2024 - 04/2025) Status: Approved
  • SWOG A031201: Phase III trial of enzalutamide (NSC #766085) versus anzalutamide, abiraterone and prednisone for castration resistant metastatic prostate cancer, Role: Investigator, Southwest Oncology Group, (04/2020 - 04/2021) Status: Completed
  • CLDK378A2112: A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC), Role: Investigator, Novartis Pharmaceuticals Corporation, (01/2020 - 01/2021) Status: Completed
  • SWOG A151216: adjuvant lung cancer enrichment marker identification and sequencing trial (ALCHEMIST), Role: Investigator, Southwest Oncology Group, (10/2023 - 10/2024) Status: Approved
  • SWOG-A081105: randomized study of Erlotinib VS Observation in patients with completely resected Epidermal Growth Factor Receptor (EGFR) mutant Non-small Cell Lung Cancer (NSCLC), Role: Investigator, Southwest Oncology Group, (09/2023 - 09/2024) Status: Approved
  • SWOG E4512: a phase III double-blind trial for surgically resected early stage non-small cell lung cancer: Crizotinib versus Placebo for patients with tumors harboring the Anaplastic Lymphoma Kinase (ALK) fusion protein, Role: Investigator, Southwest Oncology Group, (11/2023 - 11/2024) Status: Approved
  • SWOG A011202: a randomized phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (cT1-3 N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy, Role: Investigator, Southwest Oncology Group, (08/2023 - 08/2024) Status: Approved
  • SWOG-A011106:ALTernate approaches for clinical stage II or III estrogen receptor positive breast cancer NeoAdjuvant TreEatment (ALTERNATE) in postmenopausal women: a phase III study, Role: PI, Southwest Oncology Group, (09/2023 - 09/2024) Status: Approved
  • Eli Lilly & Co I3Y-MC-JPBK JUNIPER: A randomized phase 3 study of Abemaciclib plus best supportive care versus erlotinib plus best supportive care in patients with stage IV NSCLC with a detectable KRAS mutation who have progressed after platinum-based chemotherapy, Role: Investigator, Eli Lilly & Co., (11/2016 - 11/2017) Status: Completed
  • Bristol-Myers Squibb - CA204112: A phase 2, single arm study of safety of elotuzumab administered over approximately 60 minutes in combination with lenalidomide and dexamethasone for newly diagnosed or relapsed/refractory multiple myeloma patients, Role: Investigator, Bristol-Myers Squibb Company, (07/2019 - 07/2020) Status: Completed
  • Bio-Cancer Treatment International Ltd.-BCT-100-005: Recombinant human arginase 1 (rhArg1) in patients with advanced, arginine auxotrophic solid tumors: Dose escalation, safety and PK/PD, Role: Investigator, Bio-Cancer Treatment International, Ltd., (04/2020 - 04/2021) Status: Completed
  • SWOG-S1207: Phase III randomized, placebo-controlled clinical trial evaluating the use of adjuvant endocrine therapy +/- one year of EVEROLIMUS in patients with high-risk hormone receptor-positive AND HER2/neu negative breast cancer e3 breast cancer study - evaluating everolimus with endocrine therapy, Role: PI, Southwest Oncology Group, (01/2024 - 01/2025) Status: Approved
  • SWOG-S1216: a phase III randomized trial comparing androgen deprivation therapy + TAK-700 with androgen deprivation therapy + bicalutamide in patients with newly diagnosed metastatic hormone sensitive prostate cancer, Role: Investigator, Southwest Oncology Group, (12/2023 - 12/2024) Status: Approved
  • Novartis - CRAD001Y24135: an open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer, Role: PI, Novartis Pharmaceuticals Corporation, (02/2020 - 02/2021) Status: Completed
  • SWOG-S0820: A double blind placebo-controlled trial of eflornithine and sulindac to prevent recurrence of high risk adenomas and second primary colorectal cancers in patients with stage 0-III colon cancer, phase III - preventing adenomas of the colon with eflornithine and sulindac (PACES), Role: Investigator, Southwest Oncology Group, (09/2023 - 09/2024) Status: Approved
  • SWOG - E1908: A phase II randomized trial comparing standard and low dose rituximab: Initial treatment of progressive chronic lymphocytic leukemia in elderly patients using alemtuzumab and rituximab, Role: Investigator, Southwest Oncology Group, (07/2013 - 07/2014) Status: Completed
  • Daiichi Sankyo Pharma Development - DS2248-A-U101 - A phase 1, open label, multiple-ascending dose study of DS-2248, an orally biovailable heat shock protein 90 inhibitor in subjects with advance solid tumors, Role: Investigator, Daiichi Sankyo Pharma Development, (05/2014 - 05/2015) Status: Completed
  • SWOG-S1013: A prospective study of epidermal growth receptor (HER-1/EGFR) inhibitor-induced dermatologic toxicity: validation of the functional assessment of cancer therapy-EGFRI 18 (FACT-EGFRI 18) questionnaire for EGFR-induced skin toxicities, Role: Investigator, Southwest Oncology Group, (09/2019 - 09/2020) Status: Completed
  • SWOG-S1007: A phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER-2 negative breast cancer with recurrence score (RS) of 25 or less. RxPONDER: A clinical trial Rx for positive node, endocrine responsive breast cancer, Role: PI, Southwest Oncology Group, (01/2024 - 01/2025) Status: Approved
  • Merrimack Pharmaceuticals - MM-121-01-101: A phase 1-2 trial of MM-121 in combination with erlotinib in three groups of patients with non-small cell lung cancer, Role: Investigator, Merrimack Pharmaceuticals, (11/2013 - 10/2014) Status: Completed
  • Pfizer Inc.- A8081014: Phase 3, randomized, open-label study of the efficacy and safety of crizotinib versus pemetrexed/cisplatin or pemetrexed/carboplatin in previously untreated patients with non-squamous carcinoma of the lung harboring a translocation or inversion event involving the anaplastic lymphoma kinase (ALK) gene locus, Role: Investigator, Pfizer Pharmaceuticals, (07/2016 - 07/2017) Status: Completed
  • Southwest Oncology Group (SWOG) - S0800: A randomized phase II trial of weekly nanoparticle albumin bound pacilitaxel (nab-pacilitaxel) (NSC-736631) with or without bevacizumab, either preceded by or followed by Q 2 week doxorubicin (A) and cyclophosphamide (c) plus pegfilgrastim (PEG-G) as neoadjuvant therapy for inflammatory and locally advanced her-2/neu negative breast cancer, Role: PI, Southwest Oncology Group, (05/2018 - 05/2019) Status: Completed
  • SWOG 9512. A phase III study of adjuvant Ganglioside vaccination GM2-KLH/QS-21 therapy vx hihg-dose inferferon Alfa-2b (IntronA) for high risk melanoma (T4>4mm primary or regional lymph node metastasis, Role: PI, Southwest Oncology Group, (05/2017 - 05/2018) Status: Completed

Internal

  • LLU Cancer Center biospecimen laboratory - specimens collection protocol, Role: Investigator, LLU Cancer Institute, (09/2023 - 09/2024) Status: Approved
  • Can less be more? Real-world outcomes of patients requiring dose-reductions for cyclin-dependent kinase (CDK) 4/6 inhibitors for advanced or metastatic breast cancer: a single-center experience, Role: Investigator, LLU Dept. of Pharmacy Practice, (01/2023) Status: Approved
  • Investigator Initiated: A Retrospective chart review of patients treated with immune checkpoint inhibitors (ICI) to evaluate severe and fatal adverse events in the emergency department, Role: Investigator, LLU Dept. of Pharmacy Practice, (07/2021) Status: Approved
  • Investigator Initiated Retrospective Chart Review: Identify risk factors for cardiovascular complications in patients undergoing cancer treatment, Role: PI, LLU Dept. of Medicine, (06/2021) Status: Approved
  • Investigator Initiated: Creation of registry for patients receiving neoadjuvant systemic therapy for Breast Cancer, Role: PI, LLU Dept. of Medicine, (01/2021) Status: Approved
  • Effects of chemotherapy on the concentration of minerals in hair, Role: Investigator, LLU Dept. of Allied Health Studies, (07/2019) Status: Completed
  • Investigator initiated: Conventional prophylactic regimen of oral dexamethasone versus short-course intravenous dexamethasone in preventing paclitaxel-related hypersensitivity reactions in breast and gynecologic-oncology patients: A prospective, randomized, open-label study, Role: Investigator, LLU Dept. of Gynecology & Obstetrics, (02/2024 - 02/2025) Status: Approved
  • Investigator initiated CIPNGRASP: A pilot study of intraneural facilitation for managing chemotherapy-induced peripheral neuropathy, Role: PI, LLU Dept. of Medicine, (04/2023 - 04/2024) Status: Completed
  • Inv. Int - Targeting putative stemness biomarker alpha6-integrin to reverse Tamoxifen resistance, Role: PI, LLU Dept. of Medicine, (06/2018 - 06/2019) Status: Completed
  • Medication reconciliation in an ambulatory cancer center --impact of the oncology pharmacist, Role: Investigator, LLU Dept. of Pharmacy Practice, (07/2016 - 07/2017) Status: Completed
  • Intraneural facilitation: Managing chemotherapy-induced peripheral neuropathy, Role: PD/PI, LLU - GRASP, (04/2017 - 01/2022) Status: Awarded
  • Targeting putative stemness biomarker alpha6 integrin to reverse Tamoxifen resistance, Role: PD/PI, LLU School of Medicine, (02/2016 - 01/2018) Status: Closed

Non-Profit Organization

  • National surgical adjuvant breast and bowel project (NSABP) protocol #B-40: A randomized phase III trial of neoadjuvant therapy in patients with palpable and operable breast cancer evaluating the effect on pathologic complete response (pCR) of adding capecitabine or gemcitabine to docetaxel when administered before, Role: PI, National Surgical Adjuvant Breast & Bowel Project, (05/2018 - 05/2019) Status: Completed
  • Global Cardio Oncology Registry (G-COR), Role: Investigator, Cleveland Clinic Foundation, (03/2023) Status: Approved
  • NSABP B-58: A randomized open-label, phase 3 study of abemaciclib combined with standard adjuvant endocrine therapy alone in patients with high risk, node positive, early stage, hormone receptor positive, human epidermal receptor 2 negative breast cancer, Role: PI, National Surgical Adjuvant Breast & Bowel Project, (10/2019 - 10/2020) Status: Completed
  • NSABP B51 / RTOG 1304: a randomized phase III clinical trial evaluating post-mastectomy chest wall and regional nodal XRT and post-lumpectomy regional nodal XRT in patients with positive axillary nodes before neoadjuvant chemotherapy who convert to pathologically negative axillary nodes after neoadjuvant chemotherapy, Role: Investigator, National Surgical Adjuvant Breast & Bowel Project, (10/2023 - 10/2024) Status: Approved
  • NSABP B52: A randomized phase III trial evaluating pathologic complete response rates in patients with hormone receptor-positive, HER2-positive, large operable and locally advanced breast cancer treated with neoadjuvant therapy of docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) with or without estrogen deprivation, Role: PI, National Surgical Adjuvant Breast & Bowel Project, (07/2023 - 07/2024) Status: Approved
  • NSABP - FB-7: A phase II randomized clinical trial evaluating neoadjuvant therapy regimens with weekly paclitaxel plus neratinib or trastuzumab or neratinib and trastuzumab followed by doxorubicin and cyclophosphamide with postoperative trastuzumab in women with locally advanced HER2-positive breast cancer, Role: PI, National Surgical Adjuvant Breast & Bowel Project, (07/2017 - 07/2018) Status: Completed
  • NSABP B43: A phase III clinical trial comparing trastuzumab given concurrently with radiation therapy and radiation therapy alone for women with HER2-positive ductal carcinoma in situ resected by lumpectomy, Role: PI, National Surgical Adjuvant Breast & Bowel Project, (01/2024 - 01/2025) Status: Approved
  • NSABP-B31 - A randomized trial comparing the safety and efficacy of adriamycin and cyclophosphamide followed by taxol (AC-T) to that of adriamycin and cyclophosphmide followed by taxol plus herceptin (AC-T+HC) in node-positive breast cancer patients who have tumors that overexpress HER2., Role: PI, National Surgical Adjuvant Breast & Bowel Project, (12/2019 - 12/2020) Status: Completed
  • (MonarchE: I3Y-MC-JPCF) A Randomized, Open-Label, Phase 3 Study of Abemaciclib combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk Node Positive Early Stage Hormone Receptor Positive, Human Epidermal Receptor 2 Negative Breast Cancer, Role: Principal Investigator, Lilly USA, (03/2018 - 03/2019) Status: Closed