Breast Cancer Clinical Trial
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted
Adults ≥18 years old. Other age restrictions may apply as per local regulations.
Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations locally determined by NGS, who have progressed following prior treatment or who have no satisfactory alternative treatment options.
Prior HER2 targeted therapy is permitted.
All patients must provide an FFPE tumor sample for retrospective central HER2 testing.
HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
HER2 mutant NSCLC.
History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
Lung-specific intercurrent clinically significant severe illnesses.
History of active primary immunodeficiency, known HIV, active HBV or HCV infection
Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals
Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
Has spinal cord compression or clinically active central nervous system metastases.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 30 Locations for this study
Santa Rosa California, 95403, United States
Muncie Indiana, 47303, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Middletown New Jersey, 07748, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10021, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Anderlecht , 1070, Belgium
Toronto CA, M5G 2, Canada
Copenhagen , 2100, Denmark
Bordeaux , 33076, France
Lyon Cedex 08 , 69008, France
Villejuif , 94805, France
Milano , 20162, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Chuo-ku , 104-0, Japan
Kashiwa , 277-8, Japan
Suita-shi , 565-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Barcelona , 08035, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Pamplona , 31008, Spain
Sevilla , 41013, Spain
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.