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

Launched by MAYO CLINIC · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called ado-trastuzumab emtansine (T-DM1) on patients with HER2-positive breast cancer, particularly focusing on a condition known as peripheral neuropathy, which can cause tingling, numbness, or pain in the hands and feet. Researchers want to understand how this medication affects patients who have never experienced nerve problems before, as well as those who have a history of nerve issues. The goal is to gather important information that could help improve care for future patients.

To participate in the study, individuals must be planning to receive three or more doses of T-DM1 for their breast cancer treatment. They can have a history of nerve problems, but they should not have used T-DM1 or certain other nerve-damaging cancer treatments recently. Participants will be asked to complete a questionnaire about their experiences and will be monitored during their treatment. This study is currently recruiting patients of any gender, aged 65 to 74, who are willing to provide informed consent and follow up at the same medical center where they start the trial.

Gender

ALL

Eligibility criteria

• 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.