Actively Recruiting
Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-21
200
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective, response-guided phase II study investigates individualized neoadjuvant treatment strategies for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. After receiving neoadjuvant dual-HER2-targeted therapy with chemotherapy, patients are evaluated for their treatment response. Those achieving an adequate response continue the therapy, whereas patients with a suboptimal response transition to an intensified investigational regimen incorporating novel targeted agents. This adaptive approach aims to optimize pathologic response, minimize unnecessary toxicity, and explore more effective treatment options for individuals with insufficient benefit from conventional neoadjuvant therapy.
CONDITIONS
Official Title
Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Primary tumor size larger than 1 cm
- Histologically confirmed invasive breast cancer, clinically staged as Stage I (T1cN0M0), Stage II (T1cN1M0, T2N0-1M0, or T3N0M0), or Stage III (T2N2-3M0, T3N1-3M0, or T4N0-3M0)
- HER2-positive status confirmed by IHC 3+ or IHC 2+ with positive ISH
- Adequate hematology: hemoglobin ≥100 g/L, absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L without transfusion or growth factors within 14 days
- Adequate biochemistry: total bilirubin ≤1.5 × upper limit of normal (ULN), ALT and AST ≤1.5 × ULN, ALP ≤2.5 × ULN, BUN and creatinine ≤1.5 × ULN
- Cardiac function with left ventricular ejection fraction (LVEF) ≥55% by echocardiography
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use effective contraception during the study and for 8 weeks after last dose
- Provide voluntary written informed consent and agree to comply with study procedures and follow-up
You will not qualify if you...
- Prior anti-tumor therapy for breast cancer including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy
- Concurrent use of any other anti-tumor treatment
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer
- Breast cancer not confirmed by histology
- History of other malignancy within past 5 years except successfully treated cervical carcinoma in situ
- Severe dysfunction of major organs such as heart, liver, or kidney
- Conditions preventing oral drug administration or absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Participation in another investigational drug trial within 4 weeks prior to enrollment
- Known hypersensitivity to study drug components or history of immunodeficiency (e.g., HIV positive, active hepatitis B or C, prior organ transplantation)
- Clinically significant cardiac disease including arrhythmia requiring medication, myocardial infarction, heart failure, or other conditions considered unsuitable by investigator
- Pregnant or breastfeeding women or women unwilling to use effective contraception throughout study
- Any condition posing serious risk to patient safety or interfering with study completion such as uncontrolled severe hypertension, uncontrolled diabetes, or active infection
- History of neurological or psychiatric disorders such as epilepsy or dementia or other incompatible conditions as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
Y
Yiding Chen
CONTACT
Y
Yunxiang Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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