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| ID | Type | Description | Link |
|---|---|---|---|
| 22-010634 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MNCCTN031 | Other Identifier | Minnesota Cancer Clinical Trials Network |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in chronic neuropathy symptoms | 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. | Baseline, approximately 22 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan S. Childs, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverwood Healthcare Center | Aitkin | Minnesota | 56431 | United States | ||
| Essentia Health Baxter Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Baxter |
| Minnesota |
| 56425 |
| United States |
| Essentia Health Saint Joseph's Medical Center | Brainerd | Minnesota | 56401 | United States |
| Essentia Health - Deer River Clinic | Deer River | Minnesota | 56636 | United States |
| Essentia Health Saint Mary's - Detroit Lakes Clinic | Detroit Lakes | Minnesota | 56501 | United States |
| Essentia Health Cancer Center | Duluth | Minnesota | 55805 | United States |
| Essentia Health Ely Clinic | Ely | Minnesota | 55731 | United States |
| Essentia Health - Fosston | Fosston | Minnesota | 56542 | United States |
| Fairview Grand Itasca Clinic & Hospital | Grand Rapids | Minnesota | 55744 | United States |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | United States |
| Fairview Range Medical Center | Hibbing | Minnesota | 55746 | United States |
| Essentia Health - International Falls Clinic | International Falls | Minnesota | 56649 | United States |
| MMCORC CentraCare Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| Essentia Health Moose Lake | Moose Lake | Minnesota | 55767 | United States |
| Essentia Health - Park Rapids | Park Rapids | Minnesota | 56470 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55731 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | United States |
| Sanford Health Thief River Falls Clinic | Thief River Falls | Minnesota | 56701 | United States |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | United States |
| Sanford Health Worthington | Worthington | Minnesota | 56187 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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