What is disitamab vedotin studying for HER2-low breast cancer?

Disitamab vedotin is being studied in combination with bevacizumab to evaluate its safety and effectiveness in patients with HER2-low advanced breast cancer after progression on prior T-DXd therapy. Researchers aim to understand how well this treatment works and identify factors that may predict patient response. The study is sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who may be eligible for this HER2-low breast cancer clinical trial?

Women aged 18 to 75 years with advanced or metastatic HER2-low breast cancer who have previously received T-DXd treatment may be eligible. Participants must have measurable disease and adequate heart function. Certain health conditions like active infections or severe systemic diseases may exclude participation. Please review eligibility criteria for more details.

Is there any cost to participate in this HER2-low breast cancer clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

FEMALE

ID07446452

A Phase II Study of Disitamab Vedotin and Bevacizumab in HER2-Low Metastatic Breast Cancer After Progression on Prior T-DXd Therapy

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-03

Participants Needed

Research Sites

3 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of disitamab vedotin combined with bevacizumab in patients with HER2-low advanced or metastatic breast cancer who have previously experienced disease progression after treatment with trastuzumab deruxtecan T-DXd. This phase II clinical trial aims to assess how well this combination works and its safety profile, while also exploring molecular factors that might predict patient response to treatment. Participants receive disitamab vedotin RC48 intravenously at a dose of 2.0 mgkg every two weeks along with bevacizumab at 5 mgkg intravenously every two weeks. Treatment continues until the disease progresses, unacceptable side effects occur, consent is withdrawn, or new anticancer therapy is started. The study includes close monitoring of treatment-related side effects, with adjustments made as needed to ensure participant safety. Throughout the study, patients undergo regular assessments including imaging to evaluate tumor response, laboratory tests, and quality of life questionnaires using the EORTC QLQ-C30 at baseline and every eight weeks during treatment. Researchers will measure outcomes such as objective response rate, progression-free survival, overall survival, disease control rate, and duration of response. Safety evaluations include tracking adverse events during treatment and for 90 days after the last dose. The study duration includes follow-up for up to 36 months to monitor long-term outcomes.

CONDITIONS

Brief Title

Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

Who Can Participate

Age: 18Years - 75Years

FEMALE

Eligibility Criteria

You may qualify if you...

Signed written informed consent before starting any study procedures
Female participants aged 18 years or older
Histologically or cytologically confirmed advanced or 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 tumor lesion according to RECIST version 1.1
ECOG performance status of 0 to 2
Expected survival time greater than 3 months
Left ventricular ejection fraction (LVEF) of 50% or higher within 4 weeks before first dose
Adequate organ function as determined by laboratory tests and investigator judgment

You will not qualify if you...

Uncontrolled comorbid medical 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 lung diseases
Prior allogeneic organ or hematopoietic stem cell transplantation (except corneal transplant)
Known allergy to bevacizumab, disitamab vedotin, or their components
Spinal cord compression or active central nervous system metastases
Unresolved side effects from prior therapies worse than Grade 1
Known HIV infection
Untreated active hepatitis B or active hepatitis C infection
Receipt of a live vaccine within 30 days before starting treatment
Pregnant or breastfeeding women
Severe or uncontrolled systemic diseases interfering with study participation or safety
Gastrointestinal perforation, fistula, wound healing problems requiring medical treatment, severe bleeding, arterial thrombosis, or life-threatening venous thromboembolism

Research Team

Wei Li, Ph.D

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