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

NCT05889988 | Active Not Recruiting DMC

• 3 other identifiers: MC22090422-010634MNCCTN031
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Breast Neoplasm

Keywords

Ado-trastuzumab emtansine (T-DM1); Peripheral Neuropathy; HER2-positive

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (21)

Riverwood Healthcare Center

Aitkin, Minnesota, 56431, United States

Location

Essentia Health Baxter Clinic

Baxter, Minnesota, 56425, United States

Location

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401, United States

Location

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636, United States

Location

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501, United States

Location

Essentia Health Cancer Center

Duluth, Minnesota, 55805, United States

Location

Essentia Health Ely Clinic

Ely, Minnesota, 55731, United States

Location

Essentia Health - Fosston

Fosston, Minnesota, 56542, United States

Location

Fairview Grand Itasca Clinic & Hospital

Grand Rapids, Minnesota, 55744, United States

Location

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746, United States

Location

Fairview Range Medical Center

Hibbing, Minnesota, 55746, United States

Location

Essentia Health - International Falls Clinic

International Falls, Minnesota, 56649, United States

Location

MMCORC CentraCare Monticello Cancer Center

Monticello, Minnesota, 55362, United States

Location

Essentia Health Moose Lake

Moose Lake, Minnesota, 55767, United States

Location

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470, United States

Location

Fairview Northland Medical Center

Princeton, Minnesota, 55731, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Essentia Health Sandstone

Sandstone, Minnesota, 55072, United States

Location

Sanford Health Thief River Falls Clinic

Thief River Falls, Minnesota, 56701, United States

Location

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792, United States

Location

Sanford Health Worthington

Worthington, Minnesota, 56187, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dan S. Childs, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 5, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)