ACTIVE_NOT_RECRUITING

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

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Conditions

Breast NeoplasmAdo-trastuzumab emtansine (T-DM1)Peripheral NeuropathyHER2-positive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-12
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05889988

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  3. * The patient plans to continue clinical follow-up at the same institution, where the patient entered the study.
  4. * Provide informed consent.
  5. * Ability to complete questionnaire(s) in English by themselves or with assistance.
  1. * Previous use of T-DM1
  2. * 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.
  3. * 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.

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Neoplasm