Trastuzumab Emtansine and Chemoradiation for the Treatment of HER2-Positive, Resectable Stage II-IVB Salivary Gland Cancer

Active:	Yes
Cancer Type:	Head and Neck Cancer Unknown Primary	NCT ID:	NCT04620187
Trial Phases:	Phase II	Protocol IDs:	20-432 (primary) NCI-2021-00574
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Dana-Farber Harvard Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04620187

Summary

This phase II trial studies the effect of trastuzumab emtansine (T-DM1) and standard chemoradiation (chemotherapy and radiation therapy) in treating patients with HER2-positive stage II-IVB salivary gland cancer that can be removed by surgery (resectable). T-DM1 is a specialized antibody targeting HER2 (a protein that is expressed in some breast and salivary gland cancers). The drug is an HER2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows doctors to use a targeted treatment along with chemoradiation to treat HER2 expressing salivary cancers. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving T-DM1 with standard chemoradiation may help control salivary gland cancer.

Objectives

PRIMARY OBJECTIVE:
I. To estimate disease-free survival (DFS) at 2-years from the date of study registration.

SECONDARY OBJECTIVES:
I. To evaluate safety and toxicity.
II. To estimate overall survival (OS) from date of study registration.
III. To estimate distant metastatic-free survival (DMFS) from date of study registration.
IV. To correlate tumor HER-2/neu receptor expression and amplification with outcomes.
V. To explore the relationship between circulating tumor (ct) deoxyribonucleic acid (DNA) and disease outcomes.

OUTLINE:
Patients undergo standard of care surgical resection. Beginning 3-7 weeks after surgery, patients receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1. Cycles repeat every 21 days for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care chemotherapy (cisplatin IV over 30-120 minutes or carboplatin IV) and standard of care radiation therapy on days 8 and 15 of cycle 1, days 1, 8, and 15 of cycle 2, and day 1 of cycle 3 in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy at screening, echocardiography (ECG) or magnetic resonance imaging (MRI) or multigated acquisition (MUGA) scan, and collection of blood and/or tumor samples throughout the trial.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.