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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Neoplasm
Intervention / Treatment

-

Contacts and Locations

Baxter

Essentia Health Baxter Clinic, Baxter, Minnesota, United States, 56425

Brainerd

Essentia Health Saint Joseph's Medical Center, Brainerd, Minnesota, United States, 56401

Deer River

Essentia Health - Deer River Clinic, Deer River, Minnesota, United States, 56636

Detroit Lakes

Essentia Health Saint Mary's - Detroit Lakes Clinic, Detroit Lakes, Minnesota, United States, 56501

Duluth

Essentia Health Cancer Center, Duluth, Minnesota, United States, 55805

Ely

Essentia Health Ely Clinic, Ely, Minnesota, United States, 55731

Fosston

Essentia Health - Fosston, Fosston, Minnesota, United States, 56542

Grand Rapids

Fairview Grand Itasca Clinic & Hospital, Grand Rapids, Minnesota, United States, 55744

Hibbing

Essentia Health Hibbing Clinic, Hibbing, Minnesota, United States, 55746

Hibbing

Fairview Range Medical Center, Hibbing, Minnesota, United States, 55746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

Dan S. Childs, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

2025-06