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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

Tracking Information
First Submitted Date May 25, 2023
First Posted Date June 5, 2023
Last Update Posted Date January 8, 2024
Actual Study Start Date June 12, 2023
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2023)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Breast Neoplasm
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 25, 2023)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu
Contact: Angela M. Gosch 507-538-0415 Gosch.Angela@mayo.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05889988
Other Study ID Numbers MC220904
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Mayo Clinic
Original Responsible Party Same as current
Current Study Sponsor Mayo Clinic
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Charles L. Loprinzi, M.D. Mayo Clinic in Rochester
PRS Account Mayo Clinic
Verification Date January 2024