Actively Recruiting
HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
Led by Fudan University · Updated on 2026-05-14
100
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will be conducted as an open-label, single-center, Phase II clinical study, with a planned enrollment of 70 patients with locally advanced or metastatic HER2-positive and HER2-low breast cancer who are intended to receive at least two cycles of T-DXd monotherapy. All patients receiving T-DXd treatment must meet current clinical indications. After screening and enrollment, participants will undergo FDG-PET scans and free-of-charge HER2-PET scans prior to T-DXd treatment, with tissue biopsies performed as needed. Participants will receive single-agent T-DXd treatment until disease progression, with additional tissue biopsies performed as needed.This study will integrate and analyze patients' baseline clinical characteristics, treatment efficacy, and prognostic information, along with HER2 expression levels and HER2 expression heterogeneity as assessed by HER2-PET, to evaluate the feasibility of guiding T-DXd treatment in patients with advanced breast cancer.
CONDITIONS
Official Title
HER2-PET: Predicting T-DXd Efficacy and HER2 Heterogeneity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed unresectable locally advanced or metastatic breast cancer with HER2-positive or HER2-low expression based on immunohistochemistry and FISH results
- Prior treatment: at least one prior anti-HER2 targeted therapy for HER2-positive breast cancer or at least one prior systemic therapy line for metastatic disease or relapse within 6 months after adjuvant chemotherapy for HER2-low breast cancer
- ECOG Performance Status of 0 or 1
- Evidence of disease progression after last systemic therapy before starting study treatment
- Anticipated life expectancy of 12 weeks or more at screening
- At least one measurable lesion not previously irradiated, with specific size requirements by imaging
- Left ventricular ejection fraction of 50% or higher within 28 days before randomization
- Adequate organ and bone marrow function within 14 days before randomization, including specified laboratory values
- Agreement to avoid egg donation or collection and breastfeeding during the study and 7 months after last treatment dose
You will not qualify if you...
- Uncontrolled concurrent diseases such as active infections, significant cardiovascular disease, severe gastrointestinal disease with diarrhea, or psychiatric/social conditions limiting compliance or increasing risk
- Uncontrolled or significant cardiovascular disease including recent myocardial infarction, symptomatic heart failure, uncontrolled hypertension, or significant arrhythmias
- History or presence of interstitial lung disease or pneumonitis requiring steroid treatment or suspected but not ruled out
- Use of immunosuppressive agents within 14 days before first study drug dose except specific corticosteroids
- Significant pulmonary comorbidities or autoimmune diseases with lung involvement or prior lung resection
- Uncontrolled infections requiring intravenous antimicrobial treatment
- Spinal cord compression or active symptomatic brain metastases requiring treatment; stable brain metastases allowed
- Active primary immunodeficiency, HIV infection, or active Hepatitis B or C infection unless PCR negative for HCV RNA
- Unresolved toxicities from prior cancer therapy not resolved to Grade 1 or baseline, except specified stable chronic toxicities
- Pregnant, lactating, or planning pregnancy; history of severe hypersensitivity to study drug or related monoclonal antibodies
- History of other primary malignancies within 3 years except certain treated or cured cancers
- Substance abuse or medical conditions interfering with study participation or evaluation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Juan Jin Attending physician
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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