Actively Recruiting
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-12-20
70
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
F
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer
CONDITIONS
Official Title
A Phase II Clinical Study of Treatment With Disitamb Vedotin Plus Pyrotinib in HER2-positive Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at the time of informed consent
- Histologically confirmed HER2 positive early breast cancer
- HER2 positive status confirmed locally following ASCOCAP guidelines
- Single or multifocal tumors sampled and confirmed HER2 positive
- Multicenter tumors sampled from each quadrant and confirmed HER2 positive centrally
- Tumors may be hormone receptor positive or negative (ER and PgR negative)
- Clinical stage II to IIIC breast cancer based on AJCC 8th edition
- Lymph node involvement confirmed by fine or coarse needle biopsy if applicable
- ECOG physical status of 0 or 1 at randomization
You will not qualify if you...
- Previous history of invasive breast cancer
- Stage IV breast cancer according to AJCC 8th edition
- Any primary malignant tumor within the past 3 years except fully resected non-melanoma skin cancer or cured in situ disease
- History of DCIS unless treated only by mastectomy
- Presence of severe or uncontrolled systemic diseases, including active infections, uncontrolled hypertension, kidney transplant, active bleeding, or severe chronic gastrointestinal diseases with diarrhea
- Uncontrolled infection requiring intravenous antibiotics, antiviral, or antifungal treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
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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