Trial Title:
A Study of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
NCT ID:
NCT05889988
Condition:
Breast Neoplasm
Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Conditions: Keywords:
Ado-trastuzumab emtansine (T-DM1)
Peripheral Neuropathy
HER2-positive
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Essentia Health Baxter Clinic
Address:
City:
Baxter
Zip:
56425
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health Saint Joseph's Medical Center
Address:
City:
Brainerd
Zip:
56401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health - Deer River Clinic
Address:
City:
Deer River
Zip:
56636
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health Saint Mary's - Detroit Lakes Clinic
Address:
City:
Detroit Lakes
Zip:
56501
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health Cancer Center
Address:
City:
Duluth
Zip:
55805
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health Ely Clinic
Address:
City:
Ely
Zip:
55731
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health - Fosston
Address:
City:
Fosston
Zip:
56542
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Fairview Grand Itasca Clinic & Hospital
Address:
City:
Grand Rapids
Zip:
55744
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Anastas Provatas, M.D.
Facility:
Name:
Essentia Health Hibbing Clinic
Address:
City:
Hibbing
Zip:
55746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Fairview Range Medical Center
Address:
City:
Hibbing
Zip:
55746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Anastas Provatas, M.D.
Facility:
Name:
Essentia Health - International Falls Clinic
Address:
City:
International Falls
Zip:
56649
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
MMCORC CentraCare Monticello Cancer Center
Address:
City:
Monticello
Zip:
55362
Country:
United States
Status:
Recruiting
Contact:
Last name:
Yan Ji, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Yan Ji, M.D.
Facility:
Name:
Essentia Health Moose Lake
Address:
City:
Moose Lake
Zip:
55767
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Essentia Health - Park Rapids
Address:
City:
Park Rapids
Zip:
56470
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Fairview Northland Medical Center
Address:
City:
Princeton
Zip:
55731
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastas Provatas, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Anastas Provatas, M.D.
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Dan S. Childs, M.D.
Facility:
Name:
Essentia Health Sandstone
Address:
City:
Sandstone
Zip:
55072
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Sanford Health Thief River Falls Clinic
Address:
City:
Thief River Falls
Zip:
56701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amit Panwalkar, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Amit Panwalkar, M.D.
Facility:
Name:
Essentia Health Virginia Clinic
Address:
City:
Virginia
Zip:
55792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bret E. Friday, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Bret E. Friday, M.D.
Facility:
Name:
Sanford Health Worthington
Address:
City:
Worthington
Zip:
56187
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jonathan Bleeker, M.D.
Phone:
612-624-2620
Email:
ccinfo@umn.edu
Contact backup:
Last name:
Jonathan Bleeker, M.D.
Start date:
June 12, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889988
https://www.mayo.edu/research/clinical-trials
