Examining nerve damage from T-DM1 in HER2-positive breast cancer patients
A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
This study looks at how the breast cancer drug T-DM1 affects nerve health over time in people with HER2-positive breast cancer, whether or not they have had nerve problems before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | trastuzumab |
| Locations | 21 sites (Aitkin, Minnesota and 20 other locations) |
| Trial ID | NCT05889988 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history of peripheral neuropathy induced by ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive breast cancer. It will include patients with and without a history of neuropathy or prior neurotoxic treatments. Participants will be required to complete a baseline questionnaire and continue follow-up at the same institution. The study will help understand the effects of T-DM1 on nerve health over time.
Who should consider this trial
Good fit: Ideal candidates are patients planning to receive three or more doses of T-DM1 for HER2-positive breast cancer, regardless of their treatment line.
Not a fit: Patients who have previously received T-DM1 or are currently using other neurotoxic anticancer agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into managing and preventing T-DM1-induced peripheral neuropathy in breast cancer patients.
How similar studies have performed: While studies on T-DM1 exist, this specific focus on neuropathy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aitkin, Minnesota and 20 other locations
- Riverwood Healthcare Center — Aitkin, Minnesota, United States (Recruiting)
- Essentia Health Baxter Clinic — Baxter, Minnesota, United States (Recruiting)
- Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States (Recruiting)
- Essentia Health - Deer River Clinic — Deer River, Minnesota, United States (Recruiting)
- Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States (Recruiting)
- Essentia Health Cancer Center — Duluth, Minnesota, United States (Recruiting)
- Essentia Health Ely Clinic — Ely, Minnesota, United States (Recruiting)
- Essentia Health - Fosston — Fosston, Minnesota, United States (Recruiting)
- Fairview Grand Itasca Clinic & Hospital — Grand Rapids, Minnesota, United States (Recruiting)
- Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States (Recruiting)
- Fairview Range Medical Center — Hibbing, Minnesota, United States (Recruiting)
- Essentia Health - International Falls Clinic — International Falls, Minnesota, United States (Recruiting)
- MMCORC CentraCare Monticello Cancer Center — Monticello, Minnesota, United States (Recruiting)
- Essentia Health Moose Lake — Moose Lake, Minnesota, United States (Recruiting)
- Essentia Health - Park Rapids — Park Rapids, Minnesota, United States (Recruiting)
- Fairview Northland Medical Center — Princeton, Minnesota, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
- Essentia Health Sandstone — Sandstone, Minnesota, United States (Recruiting)
- Sanford Health Thief River Falls Clinic — Thief River Falls, Minnesota, United States (Recruiting)
- Essentia Health Virginia Clinic — Virginia, Minnesota, United States (Recruiting)
- Sanford Health Worthington — Worthington, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Dan S. Childs, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.