The First Affiliated Hospital with Nanjing Medical University
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years.
For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.
Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).
Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).
Agree to undergo a core needle biopsy.
ECOG performance status 0 or 1.
Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, absolute neutrophil count ≥ 1.5 × 10\^9/L, AST/ALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.
No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.
Signed informed consent.
You may not be if
Male breast cancer or inflammatory breast cancer.
Metastatic breast cancer (Stage IV).
Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Concurrent other anti-tumor therapy or participation in another clinical trial.
Severe non-malignant disease that would affect compliance or place the patient at risk.
Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.
History of allergic reaction or contraindication to any component of the study drug.
Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.
Any other condition assessed by the investigator as unsuitable for inclusion.
Clareo Health | Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP
