NCT07446452RecruitingPhase 2
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
A Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamab Vedotin in Combination With Bevacizumab in Patients With HER2-Low Metastatic Breast Cancer After Progression on Prior T-DXd Therapy
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 24 Nov 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 6 Dec 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07446452
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 1 Jan 2024 to the primary completion date, 6 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks prior to enrollment.
- Use of systemic immunosuppressive medications within 14 days prior to the first dose.
- Allogeneic organ transplantation or hematopoietic stem cell transplantation (except corneal transplant).
- Unresolved toxicities or complications from prior therapy that have not recovered to baseline or ≤Grade 1 (per CTCAE v5.0).
- Receipt of a live vaccine within 30 days before Cycle 1 Day 1.
Other illness
- Uncontrolled comorbid conditions.
- History or current evidence of interstitial lung disease (ILD) or non-infectious pneumonitis.
- Known hypersensitivity to bevacizumab, disitamab vedotin, or any of their components or excipients.
- Known human immunodeficiency virus (HIV) infection (HIV-1/2 antibody positive).
- Untreated active hepatitis B infection.
- Active hepatitis C virus (HCV) infection.
- Any severe or uncontrolled systemic disease judged by the investigator to interfere with study participation or safety evaluation.
- Gastrointestinal perforation or fistula, wound dehiscence requiring medical intervention, wound-healing complications, severe hemorrhage, arterial thrombotic events, or life-threatening (Grade 4) venous thromboembolism, including pulmonary embolism.
Other
- Clinically significant pulmonary comorbidities.
- Spinal cord compression or clinically active central nervous system (CNS) metastases.
- Pregnant or breastfeeding women.
Who the study is looking for
- Signed written informed consent prior to any study-related procedures.
- Female or male participants 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) during treatment for recurrent or metastatic disease.
- At least one measurable lesion according to RECIST version 1.1. A lesion within a previous radiation field may be considered measurable if disease progression is confirmed at that site.
- ECOG performance status 0-2.
- Expected survival time \>3 months.
- Left ventricular ejection fraction (LVEF) ≥50% by ECHO or MUGA within 4 weeks prior to the first dose.
- Adequate organ function as determined by laboratory assessments per investigator's judgment.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.