Actively Recruiting
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-03
37
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of disitamab vedotin in combination with bevacizumab in patients with HER2-low advanced or metastatic breast cancer who have experienced disease progression following prior T-DXd therapy. Eligible patients must have HER2-low expression (IHC 1+ or 2+/FISH-) and have previously received T-DXd. Participants will receive RC48 (disitamab vedotin) plus bevacizumab according to the study protocol. Treatment-related adverse events will be closely monitored and managed, with severity graded according to CTCAE v5.0 criteria. Supportive care or dose adjustments will be implemented as necessary. The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DOR), all of which will be evaluated by an independent review committee. Safety assessments will include the incidence, severity, management, and outcomes of adverse events. Patient-reported quality of life will be evaluated using the EORTC QLQ-C30 questionnaire at predefined intervals. In addition, this study will conduct exploratory multi-omics translational research to investigate the potential molecular mechanisms underlying treatment response and resistance, and to identify predictive biomarkers associated with clinical outcomes. The ultimate goal is to assess the therapeutic efficacy and safety of this regimen, and to develop predictive models that may help identify HER2-low patients most likely to benefit, thereby supporting precision and individualized treatment strategies.
CONDITIONS
Official Title
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Female or male aged 18 years or older
- Histologically or cytologically confirmed advanced or recurrent/metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-)
- Received at least two cycles of trastuzumab deruxtecan (T-DXd) for recurrent or metastatic disease
- At least one measurable lesion as per RECIST version 1.1
- ECOG performance status 0 to 2
- Expected survival time greater than 3 months
- Left ventricular ejection fraction (LVEF) 50% or higher by ECHO or MUGA within 4 weeks before first dose
- Adequate organ function based on laboratory assessments
You will not qualify if you...
- Uncontrolled comorbid conditions
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks before enrollment
- History or current evidence of interstitial lung disease or non-infectious pneumonitis
- Use of systemic immunosuppressive medications within 14 days before first dose
- Clinically significant pulmonary comorbidities
- Allogeneic organ or hematopoietic stem cell transplantation (except corneal transplant)
- Known hypersensitivity to bevacizumab, disitamab vedotin, or their components
- Spinal cord compression or active central nervous system metastases
- Unresolved toxicities from prior therapy not recovered to baseline or Grade 1 or lower per CTCAE v5.0
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Receipt of live vaccine within 30 days before Cycle 1 Day 1
- Pregnant or breastfeeding women
- Severe or uncontrolled systemic disease interfering with study participation or safety
- Gastrointestinal perforation, fistula, wound complications, severe hemorrhage, arterial thrombotic events, or life-threatening venous thromboembolism including pulmonary embolism
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
Wei Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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