Actively Recruiting
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-27
120
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators plan to carry out a phase II, open-label, single-arm clinical study of short-course trastuzumab, pertuzumab combined with taxanes in the adjuvant treatment of early HER2-positive breast cancer, to explore whether 4 courses of dual HER2 blockade combined with taxanes can lead to a similar prognosis with current standard treatment, which is one-year trastuzumab monotherapy combined with chemotherapy, while reducing the adverse reactions of treatment.
CONDITIONS
Official Title
Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed unilateral primary invasive breast cancer with pT1, pN0, and M0 disease
- HER2-positive status confirmed by immunohistochemistry 3+ or immunohistochemistry 2+ and fluorescence in situ hybridisation positive according to ASCO/CAP 2018 guidelines
- Complete clinical pathological information available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Not currently pregnant or breastfeeding
- Normal organ function
- Ability to comply with planned treatment, understand the study process, and sign informed consent
You will not qualify if you...
- Bilateral or metastatic breast cancer
- Receiving neoadjuvant treatment
- Other malignancies within 5 years except cured cervical carcinoma in situ and non-melanoma skin cancer
- Severe systemic infections or other serious illnesses
- HIV infection or active hepatitis B or C infection
- Known allergy or intolerance to study drugs or their components
- Prior chemotherapy, endocrine therapy, biotherapy, or radiation therapy for any reason
- Participation in another investigational study within 4 weeks before study treatment
- Receipt of live vaccine within 30 days before study treatment
- History of mental illness or drug abuse affecting compliance
- Investigator's judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
X
Xiaosong Chen
CONTACT
Y
Yiwei Tong
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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