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

Recruiting

• Conditions: Breast Neoplasm

• Registration Number: NCT05889988
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-06-05
• Study Start: 2023-06-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in chronic neuropathy symptoms	Baseline, approximately 22 months	Measured using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-induced peripheral neuropathy (CIPN) twenty-item scale (EORTC QLQCIPN20), a validated instrument designed to elicit cancer patients' experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy. The total score of CIPN20, each of the three subscale scores (sensory, motor, autonomic), and each individual item of the CIPN20 tool will be computed following standard scoring algorithm and converted into a 0-100 scale; higher scores indicate greater severity of neuropathy symptoms.

Trial Locations

Locations (20)

Essentia Health Baxter Clinic; 🇺🇸 Baxter, Minnesota, United States

Essentia Health Cancer Center; 🇺🇸 Duluth, Minnesota, United States

Fairview Grand Itasca Clinic & Hospital; 🇺🇸 Grand Rapids, Minnesota, United States

Essentia Health - International Falls Clinic; 🇺🇸 International Falls, Minnesota, United States

MMCORC CentraCare Monticello Cancer Center; 🇺🇸 Monticello, 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

Essentia Health Saint Joseph's Medical Center; 🇺🇸 Brainerd, Minnesota, United States

Essentia Health Ely Clinic; 🇺🇸 Ely, Minnesota, United States

Essentia Health Hibbing Clinic; 🇺🇸 Hibbing, Minnesota, United States

Fairview Range Medical Center; 🇺🇸 Hibbing, Minnesota, United States

Essentia Health - Deer River Clinic; 🇺🇸 Deer River, Minnesota, United States

Essentia Health - Fosston; 🇺🇸 Fosston, Minnesota, United States

Essentia Health Moose Lake; 🇺🇸 Moose Lake, Minnesota, United States

Essentia Health Saint Mary's - Detroit Lakes Clinic; 🇺🇸 Detroit Lakes, Minnesota, United States