A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Status: Recruiting
Location: See all (21) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Minnesota
Riverwood Healthcare Center
RECRUITING
Aitkin
Essentia Health Baxter Clinic
RECRUITING
Baxter
Essentia Health Saint Joseph's Medical Center
RECRUITING
Brainerd
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Saint Mary's - Detroit Lakes Clinic
RECRUITING
Detroit Lakes
Essentia Health Cancer Center
RECRUITING
Duluth
Essentia Health Ely Clinic
RECRUITING
Ely
Essentia Health - Fosston
RECRUITING
Fosston
Fairview Grand Itasca Clinic & Hospital
RECRUITING
Grand Rapids
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Fairview Range Medical Center
RECRUITING
Hibbing
Essentia Health - International Falls Clinic
RECRUITING
International Falls
MMCORC CentraCare Monticello Cancer Center
RECRUITING
Monticello
Essentia Health Moose Lake
RECRUITING
Moose Lake
Essentia Health - Park Rapids
RECRUITING
Park Rapids
Fairview Northland Medical Center
RECRUITING
Princeton
Mayo Clinic in Rochester
RECRUITING
Rochester
Essentia Health Sandstone
RECRUITING
Sandstone
Sanford Health Thief River Falls Clinic
RECRUITING
Thief River Falls
Essentia Health Virginia Clinic
RECRUITING
Virginia
Sanford Health Worthington
RECRUITING
Worthington
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Backup
Angela M. Gosch
Gosch.Angela@mayo.edu
507-538-0415
Time Frame
Start Date:2023-06-12
Estimated Completion Date:2026-06
Participants
Target number of participants:50
Treatments
HER2 Metastatic Group
HER2 Metastatic Setting (defined by breast cancer that has spread outside of the breast and the immediately draining lymph node regions; stage IV)
HER2 Adjuvant Group
HER2 Adjuvant Setting (defined by breast cancer that is not known to have spread outside of the breast and the immediately draining lymph node regions; stages I-III). The Adjuvant Setting includes patients receiving neoadjuvant therapy.