Actively Recruiting
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2026-02-06
50
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.
CONDITIONS
Official Title
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Histologically confirmed invasive breast cancer with HER2 positivity according to 2018 ASCO-CAP guidelines
- Tumor stage II or III as per AJCC 8th edition (T1-T4, N1-N3, M0)
- At least one measurable target lesion per RECIST V1.1
- ECOG performance status score of 0 or 1
- Adequate organ function with specified blood counts and liver/kidney function within defined limits
- Left ventricular ejection fraction (LVEF) ≥ 55%
- Corrected QT interval (QTcF) < 470 msec on 12-lead ECG
- Negative pregnancy test within 7 days before treatment for premenopausal women
- Not lactating and willing to use effective contraception during treatment and for 6 months after
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Stage IV or inflammatory breast cancer
- Prior anti-tumor therapy or radiotherapy for any malignancy, or concurrent other malignancies except certain cured skin and cervical conditions
- Participation in other anti-tumor clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before the first study drug dose or incomplete recovery from such surgery
- Serious cardiac diseases including heart failure (LVEF < 50%), uncontrolled arrhythmias, angina requiring medication, severe valve disease, or recent myocardial infarction
- Uncontrolled hypertension above specified thresholds
- Uncontrolled active infection or history of immunodeficiency
- Known allergy to study drugs
- Pregnant or lactating women, or women unwilling to use contraception during and 6 months after treatment
- Known or suspected interstitial lung disease or severe pulmonary diseases interfering with treatment
- Severe concomitant diseases or other conditions deemed unsuitable by investigator
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
Actively Recruiting
Research Team
X
Xiaosong Chen, Ph.D
CONTACT
J
Jiayi Wu, 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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