A Study of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
NCT ID: NCT05889988
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
36 participants
OBSERVATIONAL
2023-06-12
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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)
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Dan S. Childs, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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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
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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22-010634
Identifier Type: OTHER
Identifier Source: secondary_id
MNCCTN031
Identifier Type: OTHER
Identifier Source: secondary_id
MC220904
Identifier Type: -
Identifier Source: org_study_id