Clinical trial NCT05889988: A Study of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Official title: A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasm
Keywords: Ado-trastuzumab emtansine (T-DM1)
Peripheral Neuropathy
HER2-positive
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


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.

Primary outcomes:
measure: Change in chronic neuropathy symptoms
timeFrame: Baseline, approximately 22 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aitkin
country: United States
facility: Riverwood Healthcare Center
state: Minnesota
city: Baxter
country: United States
facility: Essentia Health Baxter Clinic
state: Minnesota
city: Brainerd
country: United States
facility: Essentia Health Saint Joseph's Medical Center
state: Minnesota
city: Deer River
country: United States
facility: Essentia Health - Deer River Clinic
state: Minnesota
city: Detroit Lakes
country: United States
facility: Essentia Health Saint Mary's - Detroit Lakes Clinic
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health Cancer Center
state: Minnesota
city: Ely
country: United States
facility: Essentia Health Ely Clinic
state: Minnesota
city: Fosston
country: United States
facility: Essentia Health - Fosston
state: Minnesota
city: Grand Rapids
country: United States
facility: Fairview Grand Itasca Clinic & Hospital
state: Minnesota
city: Hibbing
country: United States
facility: Essentia Health Hibbing Clinic
state: Minnesota
city: Hibbing
country: United States
facility: Fairview Range Medical Center
state: Minnesota
city: International Falls
country: United States
facility: Essentia Health - International Falls Clinic
state: Minnesota
city: Monticello
country: United States
facility: MMCORC CentraCare Monticello Cancer Center
state: Minnesota
city: Moose Lake
country: United States
facility: Essentia Health Moose Lake
state: Minnesota
city: Park Rapids
country: United States
facility: Essentia Health - Park Rapids
state: Minnesota
city: Princeton
country: United States
facility: Fairview Northland Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Sandstone
country: United States
facility: Essentia Health Sandstone
state: Minnesota
city: Thief River Falls
country: United States
facility: Sanford Health Thief River Falls Clinic
state: Minnesota
city: Virginia
country: United States
facility: Essentia Health Virginia Clinic
state: Minnesota
city: Worthington
country: United States
facility: Sanford Health Worthington
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Dan S. Childs, M.D.
role: PRINCIPAL_INVESTIGATOR
References: