THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on targeted therapy in HER2-positive breast cancer. These trials are studying imaging as a predictor of treatment response, combination therapies, treatments for metastatic disease, radiotherapy, radiosurgery, and more.
All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
PHASE I
Study Title: PET Imaging With 89Zr-Trastuzumab for Prediction of HER2-Targeted Therapy Effectiveness
Study Type: Interventional/single-group assignment
Study Sponsor and Collaborators: University of Alabama at Birmingham
Purpose: To investigate the use of 89Zr-trastuzumab as a HER2-imaging agent to determine which patients are likely to respond to targeted HER2 agents as single-agent therapy
Primary Outcome Measures: Investigate the use of [89Zr]-Df-Trastuzumab as a HER2-imaging agent [time frame: 24 months]
Principal Investigator: Suzanne Lapi, PhD, University of Alabama at Birmingham; contact Denise Jeffers, PharmD, (205) 975-6469, charlottejeffers@uabmc.edu
ClinicalTrials.gov Identifier: NCT03321045
PHASE I/II
Study Title: Phase I/II Study of T-DM1 Alone vs T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery
Study Type: Interventional/randomized/sequential assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To determine whether treatment with temozolomide plus ado-trastuzumab emtansine (formerly known as T-DM1) lowers the chance of new metastases in the brain after stereotactic radiosurgery
Primary Outcome Measures: Maximum tolerated dose of temozolomide when used with ado-trastuzumab emtansine [time frame: every 21 days]; median amount of time subject survives without disease progression after treatment [time frame: at disease progression]
Principal Investigator: Alexandra S. Zimmer, MD, National Cancer Institute; contact Nicole D. Houston, RN, (240) 760-6127, houstonnd@mail.nih.gov
ClinicalTrials.gov Identifier: NCT03190967
PHASE II
Study Title: A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2–) in the Neoadjuvant Setting
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: University of California, Irvine
Purpose: To study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2-positive disease and carboplatin and paclitaxel with bevacizumab in HER2-negative disease in the neoadjuvant setting for the treatment of breast cancer
Primary Outcome Measures: 2-year progression-free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting [time frame: 2 years]
Principal Investigator: Rita Mehta, MD, University of California, Irvine; contact UC Irvine Health Chao Family Comprehensive Cancer Center, 1-877-UC-STUDY, ucstudy@uci.edu
ClinicalTrials.gov Identifier: NCT02436993
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Study Title: Phase II Randomized Study of Whole-Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG
Study Type: Interventional/randomized/parallel assignment
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the efficacy of whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate in treating patients with HER2-positive, metastatic breast cancer
Primary Outcome Measures: Complete response rate in the measurable brain metastases measured by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on magnetic resonance imaging scan of the brain [time frame: 12 weeks]
Principal Investigator: In Kim, NRG Oncology; visit clinicaltrials.gov for a full list of study locations
ClinicalTrials.gov Identifier: NCT01622868
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Study Title: A Phase II Study of Neratinib Alone and in Combination With Fulvestrant in Metastatic HER2-Nonamplified but HER2-Mutant Breast Cancer
Study Type: Interventional/nonrandomized/parallel assignment
Study Sponsor and Collaborators: Washington University School of Medicine
Purpose: To test how HER2-mutated cancer responds to treatment with neratinib
Primary Outcome Measures: Part I only: overall clinical activity of neratinib alone in patients with metastatic HER2-negative breast cancer that carry HER2 mutation; part II: fulvestrant-naive estrogen receptor–positive cohort only: clinical benefit of neratinib + fulvestrant in patients with metastatic HER2-negative estrogen receptor–positive fulvestrant-naive breast cancer that carry HER2 mutation; Part II fulvestrant-treated estrogen receptor–positive cohort only: overall clinical activity of neratinib + fulvestrant in patients with metastatic HER2-negative estrogen receptor–positive fulvestrant-treated breast cancer that carry HER2 mutation; Part II estrogen receptor–negative cohort only: overall clinical activity of neratinib in patients with metastatic HER2-negative, estrogen receptor–negative breast cancer that carry HER2 mutation [time frame: 6 months]
Principal Investigator: Cynthia Ma, MD, PhD, Washington University School of Medicine; (314) 362-9383, cynthiaxma@wustl.edu
ClinicalTrials.gov Identifier: NCT01670877 ■
Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.
