Breast Cancer Clinical Trial

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adults ≥18 years old. Other age restrictions may apply as per local regulations.
Unresectable and/or metastatic solid tumors with pre-specified HER2 mutations (S310F, S310Y, G660D, R678Q, D769Y, D769H, V777L, Y772_A775dup / A775_G776insYVMA, L755S, G778_P780dup / P780_Y781insGSP, T862A, and V842I locally determined by NGS or a validated nucleic acid-based methodology (eg, qPCR, digital PCR) on tumor tissue, 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.
LVEF ≥50%
ECOG 0-1
All patients have measurable target disease assessed by the Investigator based on RECIST v1.1

Exclusion Criteria:

HER2 overexpressing (IHC3+ or IHC2+/ISH+) breast, gastric or gastroesophageal junction adenocarcinoma.
HER2 mutant NSCLC.
Medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic CHF, unstable angina pectoris, clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke.
History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD cannot be ruled out by imaging at screening
Corrected QT interval by Fridericia's formula (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on average of the screening triplicate 12-lead ECG.
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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

102

Study ID:

NCT04639219

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 30 Locations for this study

See Locations Near You

Research Site
Santa Rosa California, 95403, United States
Research Site
Muncie Indiana, 47303, United States
Research Site
Boston Massachusetts, 02115, United States
Research Site
Boston Massachusetts, 02215, United States
Research Site
Middletown New Jersey, 07748, United States
Research Site
Commack New York, 11725, United States
Research Site
Harrison New York, 10604, United States
Research Site
New York New York, 10021, United States
Research Site
Houston Texas, 77030, United States
Research Site
Fairfax Virginia, 22031, United States
Research Site
Anderlecht , 1070, Belgium
Research Site
Toronto CA, M5G 2, Canada
Research Site
Copenhagen , 2100, Denmark
Research Site
Bordeaux , 33076, France
Research Site
Lyon Cedex 08 , 69008, France
Research Site
Villejuif Cedex , 94805, France
Research Site
Milano , 20162, Italy
Research Site
Milan , 20141, Italy
Research Site
Napoli , 80131, Italy
Research Site
Chuo-ku , 104-0, Japan
Research Site
Kashiwa , 277-8, Japan
Research Site
Suita-shi , 565-0, Japan
Research Site
Seoul , 03080, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 06351, Korea, Republic of
Research Site
Barcelona , 08035, Spain
Research Site
Madrid , 28041, Spain
Research Site
Madrid , 28050, Spain
Research Site
Pamplona , 31008, Spain
Research Site
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

102

Study ID:

NCT04639219

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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