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

Running, not enrolling

Conditions studied: Breast Neoplasm

In brief

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.

Key facts

Study ID

NCT05889988

Run by

Mayo Clinic

People needed

36

Starts

2023-06-12

Expected to finish

2027-08-01

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Riverwood Healthcare Center — Aitkin, Minnesota, United States
• Essentia Health Baxter Clinic — Baxter, Minnesota, United States
• Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
• Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
• Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States
• Essentia Health Cancer Center — Duluth, Minnesota, United States
• Essentia Health Ely Clinic — Ely, Minnesota, United States
• Essentia Health - Fosston — Fosston, Minnesota, United States
• Fairview Grand Itasca Clinic & Hospital — Grand Rapids, Minnesota, United States
• Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
• Fairview Range Medical Center — Hibbing, Minnesota, United States
• Essentia Health - International Falls Clinic — International Falls, Minnesota, United States
• MMCORC CentraCare Monticello Cancer Center — Monticello, Minnesota, United States
• Essentia Health Moose Lake — Moose Lake, Minnesota, United States
• Essentia Health - Park Rapids — Park Rapids, Minnesota, United States
• Fairview Northland Medical Center — Princeton, Minnesota, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Essentia Health Sandstone — Sandstone, Minnesota, United States
• Sanford Health Thief River Falls Clinic — Thief River Falls, Minnesota, United States
• Essentia Health Virginia Clinic — Virginia, Minnesota, United States
• Sanford Health Worthington — Worthington, Minnesota, United States

Full record on ClinicalTrials.gov

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