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New study tracks nerve pain from breast cancer drug

NCT ID NCT05889988

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 36 people with HER2-positive breast cancer who are receiving the drug T-DM1. Researchers want to learn how often and how severely the drug causes nerve damage (peripheral neuropathy), such as numbness, tingling, or pain. Participants will report their symptoms through questionnaires over time. The goal is to better understand this side effect, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

36 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm HER2 positive breast carcinoma peripheral nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasm

Contacts and locations

Locations

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636, United States

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542, United States

  • Essentia Health - International Falls Clinic

    International Falls, Minnesota, 56649, United States

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470, United States

  • Essentia Health Baxter Clinic

    Baxter, Minnesota, 56425, United States

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805, United States

  • Essentia Health Ely Clinic

    Ely, Minnesota, 55731, United States

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746, United States

  • Essentia Health Moose Lake

    Moose Lake, Minnesota, 55767, United States

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401, United States

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501, United States

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072, United States

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792, United States

  • Fairview Grand Itasca Clinic & Hospital

    Grand Rapids, Minnesota, 55744, United States

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55731, United States

  • Fairview Range Medical Center

    Hibbing, Minnesota, 55746, United States

  • MMCORC CentraCare Monticello Cancer Center

    Monticello, Minnesota, 55362, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431, United States

  • Sanford Health Thief River Falls Clinic

    Thief River Falls, Minnesota, 56701, United States

  • Sanford Health Worthington

    Worthington, Minnesota, 56187, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.