Actively Recruiting Clinical Trials Focused on Targeted Therapy for HER2-Positive Breast Cancer


Get Permission

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

**

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

**

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.


Advertisement

Advertisement



;
Advertisement

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.