T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Neratinib in HER2-positive breast cancer with brain metastasis
Eligibility criteria
Qualifiers
Female, aged 18-70 years old.
ECOG score ranges from 0 to 1.
Expected survival period is greater than 12 weeks.
Histologically confirmed invasive HER2 positive breast cancer (HER2 IHC+++or FISH/CISH positive, all samples need to be verified by the pathology department of the research center).
Disqualifiers
Transfer treatment exceeding 2 lines, or previous use of T-DXd or nalatinib.
Meningeal metastasis.
Brain metastases that require emergency intervention treatment, or brain metastases that require treatment with more than 3mg/d dexamethasone or equivalent drugs.
A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.
Trial design
Treatments tested in this trial
- Neratinib
- Trastuzumab Deruxtecan
Treatment groups
202 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov