A Study of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients

Researchers plan to study the natural history of ado-trastuzumab emtansine (T-DM1)-induced neuropathy both in patients without any history of neuropathy or previous neurotoxic agent use and in patients who have such a history.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasm

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Aitkin, Minnesota, United States, 56431
      • Riverwood Healthcare Center
    • Baxter, Minnesota, United States, 56425
      • Essentia Health Baxter Clinic
    • Brainerd, Minnesota, United States, 56401
      • Essentia Health Saint Joseph's Medical Center
    • Deer River, Minnesota, United States, 56636
      • Essentia Health - Deer River Clinic
    • Detroit Lakes, Minnesota, United States, 56501
      • Essentia Health Saint Mary's - Detroit Lakes Clinic
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Cancer Center
    • Ely, Minnesota, United States, 55731
      • Essentia Health Ely Clinic
    • Fosston, Minnesota, United States, 56542
      • Essentia Health - Fosston
    • Grand Rapids, Minnesota, United States, 55744
      • Fairview Grand Itasca Clinic & Hospital
    • Hibbing, Minnesota, United States, 55746
      • Essentia Health Hibbing Clinic
    • Hibbing, Minnesota, United States, 55746
      • Fairview Range Medical Center
    • International Falls, Minnesota, United States, 56649
      • Essentia Health - International Falls Clinic
    • Monticello, Minnesota, United States, 55362
      • MMCORC CentraCare Monticello Cancer Center
    • Moose Lake, Minnesota, United States, 55767
      • Essentia Health Moose Lake
    • Park Rapids, Minnesota, United States, 56470
      • Essentia Health - Park Rapids
    • Princeton, Minnesota, United States, 55731
      • Fairview Northland Medical Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Sandstone, Minnesota, United States, 55072
      • Essentia Health Sandstone
    • Thief River Falls, Minnesota, United States, 56701
      • Sanford Health Thief River Falls Clinic
    • Virginia, Minnesota, United States, 55792
      • Essentia Health Virginia Clinic
    • Worthington, Minnesota, United States, 56187
      • Sanford Health Worthington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients planning to receive three or more doses of Ado-trastuzumab emtansine (T-DM1) for HER2-positive metastatic breast cancer or for earlier-stage breast cancer. Patients must have previously used neurotoxic antineoplastic agents (excluding previous use of T-DM1), have pre-existing chemotherapy-induced peripheral neuropathy (CIPN), or have peripheral neuropathy secondary to other causes. Patients must also plan to continue clinical follow-up at the same institution where they enter the study.

Description

Inclusion Criteria:

• Planning to receive three or more doses T-DM1 for HER2-positive metastatic breast cancer (any line) or for earlier-stage breast cancer. The patient may have received one dose of T-DM1, prior to study entry if it has not been longer than 14 days since that dose and that the patient will be able to complete the required baseline questionnaire within 14 days of their first dose of T-DM1.
• Patients with previous use of neurotoxic antineoplastic agents (excluding previous use of T-DM1), pre-existing CIPN, or peripheral neuropathy secondary to other causes will be able to be enrolled in the study.
• The patient plans to continue clinical follow-up at the same institution, where the patient entered the study.
• Provide informed consent.
• Ability to complete questionnaire(s) in English by themselves or with assistance.

Exclusion Criteria:

• Previous use of T-DM1
• Concomitant use of other neurotoxic anticancer agents including cisplatin, carboplatin, oxaliplatin, docetaxel, paclitaxel, vincristine, eribulin, vinorelbine, thalidomide, lenalidomide, bortezomib, or epothilones. If the patient used any of these previously, then they must have been stopped for at least 7 days prior to study entry.
• Current use of commonly used drugs for the treatment of peripheral neuropathy, including duloxetine, gabapentinoids (pregabalin and gabapentin), venlafaxine, nortriptyline, or amitriptyline (including use of these medications for things other than neuropathy). If the patient used any of these previously, then they must have been stopped for at least 7 days prior to study entry.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HER2 Metastatic Group; HER2 Metastatic Setting (defined by breast cancer that has spread outside of the breast and the immediately draining lymph node regions; stage IV)
HER2 Adjuvant Group; HER2 Adjuvant Setting (defined by breast cancer that is not known to have spread outside of the breast and the immediately draining lymph node regions; stages I-III). The Adjuvant Setting includes patients receiving neoadjuvant therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in chronic neuropathy symptoms	Measured using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-induced peripheral neuropathy (CIPN) twenty-item scale (EORTC QLQCIPN20), a validated instrument designed to elicit cancer patients' experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy. The total score of CIPN20, each of the three subscale scores (sensory, motor, autonomic), and each individual item of the CIPN20 tool will be computed following standard scoring algorithm and converted into a 0-100 scale; higher scores indicate greater severity of neuropathy symptoms.	Baseline, approximately 22 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Dan S. Childs, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: HER2-positive; Peripheral Neuropathy; Ado-trastuzumab emtansine (T-DM1)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: MC220904; 22-010634 (Other Identifier: Mayo Clinic Institutional Review Board); MNCCTN031 (Other Identifier: Minnesota Cancer Clinical Trials Network)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No