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.
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 breast and salivary gland cancers). The drug is a HER-2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers. The U.S. Food and Drug Administration (FDA) has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses (for breast cancers that express HER2 protein). The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. This research study involves radiation, chemotherapy, and targeted therapy given after surgery for up to 1-year, and participants will be followed for 3 years. It is expected that about 55 people will take part in this research study. Genentech is supporting this research study by providing the research study drug, T-DM1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
Radiotherapy to shrink or kill tumors
Intravenous injection
University of Chicago
Chicago, Illinois, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
2 Year Disease-free survival (DFS) Rate
Kaplan-Meier method will be used to estimate 2 Year Disease-free survival (DFS) Rate
Time frame: Time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause assessed up to 36 months
Adverse Events
Evaluate adverse events for patient receiving T-DM1, defined as adverse events of all grades utilizing CTCAE v5
Time frame: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Overall survival (OS) Rate
Overall Survival (OS) estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
Time frame: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
Distant metastatic-free survival (DMFS) Rate
Distant metastatic-free survival (DMFS) Rate estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
Time frame: Time from study registration to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause assessed up to 36 months
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMemorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Commack
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester
Harrison, New York, United States
RECRUITINGDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 2 more locations