Actively Recruiting
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
Led by RemeGen Co., Ltd. · Updated on 2025-10-01
40
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
CONDITIONS
Official Title
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign the informed consent form
- Age 18 years or older
- Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter > 2 cm), cN0-3, M0
- HER2-positive invasive breast tumor confirmed by central lab by IHC 3+ or IHC 2+ with ISH amplification
- Scheduled for radical breast cancer surgery and no prior systemic anti-tumor therapy
- At least one measurable lesion by RECIST v1.1 criteria
- Cardiac function NYHA class less than 3; left ventricular ejection fraction ≥ 55%
- Adequate bone marrow and organ function within 7 days prior to dosing
- Negative pregnancy test within 72 hours prior to first dose for subjects of childbearing potential
- Agree to use contraception during study and for at least 6 months after last dose
- Agree not to breastfeed or donate eggs during study and for at least 6 months after last dose
- Agree to not donate sperm during study and for at least 4 months after last dose
- Able to understand and willing to comply with study requirements and follow-up
You will not qualify if you...
- Bilateral invasive breast cancer
- Previous invasive breast cancer
- Previous carcinoma in situ of the breast with adjuvant endocrine therapy within 5 years
- Prior treatment with PD-(L)1, PD-L2, CTLA4 inhibitors or antibody-coupled drugs
- Prior anti-HER2 therapy including ADC
- Use of investigational drugs or major surgery within 4 weeks before study drug start
- Vaccination with live or attenuated vaccine within 4 weeks before or planned during study
- History of allogeneic hematopoietic stem cell or organ transplantation
- Uncontrolled or significant cardiovascular disease within 6 months prior to first dose
- History of interstitial lung disease requiring treatment or severe lung disease
- History of neurological or psychiatric disorders including epilepsy or dementia
- Persistent grade ≥2 sensory or motor neuropathy
- Active infection requiring systemic therapy within 7 days before dosing
- Positive HIV, active hepatitis B or C infection, or persistent COVID-19 infection
- Active autoimmune disease requiring systemic treatment within past 2 years
- Other malignancy within 5 years except certain treated cancers
- Known hypersensitivity to study drug components
- Any concomitant disease judged serious or interfering with study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
J
Jianmin Fang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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