T-DXd With or Without Bevacizumab for HER2-low 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 Bevicizumab in HER2-low breast cancer with brain metastasis.
Eligibility criteria
Qualifiers
ECOG score of 0 to 1.
Expected survival period greater than 12 weeks.
Histologically confirmed invasive HER2-low expressing breast cancer (specific definition: breast cancer patients with low expression of human epidermal growth factor receptor 2 (HER-2) as determined by pathological testing. Specifically: HER2 IHC 1+ or HER2 IHC++ with FISH/CISH negative. All specimens must be verified by the pathology department of the research participating center.
Tumor stage: recurrent or metastatic breast cancer; local recurrence must be confirmed by the researcher to be unable to undergo radical surgical resection.
Disqualifiers
Received more than 2 lines of chemotherapy.
Used T-DXd or bevacizumab.
Meningeal metastasis.
Brain metastasis requiring emergency intervention treatment, or brain metastasis requiring treatment with more than 3mg/d of dexamethasone or equivalent medication.
Trial design
Treatments tested in this trial
- Bevacizumab (Bev)
- Trastuzumab Deruxtecan (T-DXd)
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov