Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
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|ClinicalTrials.gov Identifier: NCT04620187|
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : December 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Cancer HER2 Gene Mutation||Drug: Ado-trastuzumab (T) emtansine (T-DM1) Radiation: Standard of Care Radiotherapy Drug: Standard of Care Chemotherapy||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas|
|Actual Study Start Date :||December 24, 2020|
|Estimated Primary Completion Date :||February 1, 2025|
|Estimated Study Completion Date :||February 1, 2026|
Experimental: Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer
Participants will undergo standard of care surgery followed by standard of care radiation and chemotherapy with the addition of T-DM1.
Study cycles are 21 days (3 weeks):
Participants will be followed for 3 years.
Drug: Ado-trastuzumab (T) emtansine (T-DM1)
Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
Other Name: Kadcyla
Radiation: Standard of Care Radiotherapy
Radiotherapy to shrink or kill tumors
Other Name: Radiation
Drug: Standard of Care Chemotherapy
- 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 ]Kaplan-Meier method will be used to estimate 2 Year Disease-free survival (DFS) Rate
- Adverse Events [ Time Frame: Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months ]Evaluate adverse events for patient receiving T-DM1, defined as adverse events of all grades utilizing CTCAE v5
- Overall survival (OS) Rate [ 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) estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
- Distant metastatic-free survival (DMFS) Rate [ 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 ]Distant metastatic-free survival (DMFS) Rate estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620187
|Contact: Glenn J Hanna, MDemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Glenn J Hanna, MD 617-632-3090 firstname.lastname@example.org|
|Principal Investigator: Glenn J Hanna, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Glenn J. Hanna, MD 617-632-3090 email@example.com|
|Principal Investigator: Glenn J. Hanna, MD|
|Principal Investigator:||Glenn J Hanna, MD||Dana-Farber Cancer Institute|