A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas
Dana-Farber Cancer Institute
Summary
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Description
This is a phase II, open-label, non-randomized, multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor (HER2)-directed therapy with adjuvant ado-trastuzumab emtansine (T-DM1) in HER2-positive salivary gland carcinomas (SGC). This research study is: * Studying the use of T-DM1 in combination with radiation and chemotherapy; and the use of maintenance T-DM1 alone for up to a year after surgery * Evaluating the effectiveness, safety, and toxicity of T-DM1 T-DM1 is a specialized antibody targeting HER-2 (a protein that is expressed in some breas…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced salivary gland carcinoma (including any histologic subtype), as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition. * Willing to provide tissue from a diagnostic biopsy or at the time of cancer resection, and blood samples before, during, and after treatment. * HER2 positive disease as defined by any of the following: * Tumor HER2 expression staining intensity of 2 or 3+ by IHC (from either a preoperativ…
Interventions
- DrugAdo-trastuzumab (T) emtansine (T-DM1)
Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
- RadiationStandard of Care Radiotherapy
Radiotherapy to shrink or kill tumors
- DrugStandard of Care Chemotherapy
Intravenous injection
Locations (13)
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of ChicagoChicago, Illinois
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Basking RidgeBasking Ridge, New Jersey
- Memorial Sloan Kettering MonmouthMiddletown, New Jersey