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

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ClinicalTrials.gov Identifier: NCT05889988
Recruitment Status : Recruiting
First Posted : June 5, 2023
Last Update Posted : January 8, 2024
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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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.

Condition or disease
Breast Neoplasm

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Natural History of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Actual Study Start Date : June 12, 2023
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in chronic neuropathy symptoms [ Time Frame: Baseline, approximately 22 months ]
    Measured using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-induced peripheral neuropathy (CIPN) twenty-item scale (EORTC QLQCIPN20), a validated instrument designed to elicit cancer patients' experience of symptoms and functional limitations related to chemotherapy-induced peripheral neuropathy. The total score of CIPN20, each of the three subscale scores (sensory, motor, autonomic), and each individual item of the CIPN20 tool will be computed following standard scoring algorithm and converted into a 0-100 scale; higher scores indicate greater severity of neuropathy symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05889988


Contacts
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Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Angela M. Gosch 507-538-0415 Gosch.Angela@mayo.edu

Locations
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United States, Minnesota
Fairview Grand Itasca Clinic & Hospital Recruiting
Grand Rapids, Minnesota, United States, 55744
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
Fairview Range Medical Center Recruiting
Hibbing, Minnesota, United States, 55746
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
MMCORC CentraCare Monticello Cancer Center Recruiting
Monticello, Minnesota, United States, 55362
Contact: Yan Ji, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Yan Ji, M.D.         
Fairview Northland Medical Center Recruiting
Princeton, Minnesota, United States, 55731
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Charles L. Loprinzi, M.D.         
Sanford Health Thief River Falls Clinic Recruiting
Thief River Falls, Minnesota, United States, 56701
Contact: Amit Panwalkar, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Amit Panwalkar, M.D.         
Sanford Health Worthington Recruiting
Worthington, Minnesota, United States, 56187
Contact: Jonathan Bleeker, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Jonathan Bleeker, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Charles L. Loprinzi, M.D. Mayo Clinic in Rochester
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05889988    
Other Study ID Numbers: MC220904
First Posted: June 5, 2023    Key Record Dates
Last Update Posted: January 8, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mayo Clinic:
Ado-trastuzumab emtansine (T-DM1)
Peripheral Neuropathy
HER2-positive
Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
 Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases