Early or locally advanced HER2-positive breast cancer
Conditions
Interventions
Experimental group:Trastuzumab Rezetecan Intensification Arm
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age = 18 years; 2.For premenopausal and perimenopausal patients, a negative pregnancy test is required, along with a commitment to use reliable contraceptive methods during the treatment period; 3.Pathologically confirmed HER2-positive (IHC 3+, or IHC 2+ and FISH+) invasive breast cancer; 4.Failure to achieve a complete response on imaging evaluation after the completion of standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) therapy; 5.Agrees to undergo tumor biopsy; 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 7.Adequate organ function meeting the following laboratory criteria: Hemoglobin = 90 g/L; White Blood Cell (WBC) count = 3.5 x 10?/L; Platelet count = 100 x 10?/L; Absolute Neutrophil Count (ANC) = 1.5 x 10?/L; Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = 3 x Upper Limit of Normal (ULN); Total Bilirubin = 1.5 x ULN; Serum Creatinine = 1.5 x ULN; 8.Electrocardiogram (ECG) showing no evidence of myocardial ischemia; New York Heart Association (NYHA) functional class I; Echocardiogram showing Left Ventricular Ejection Fraction (LVEF) = 55%; Cardiac markers (cardiac troponin I [cTnI] and brain natriuretic peptide [BNP]) within normal limits; 9.Signed informed consent form;
Exclusion criteria
Exclusion criteria: 1.Male breast cancer or inflammatory breast cancer; 2.Metastatic breast cancer (Stage IV); 3.Concurrent malignancies or a history of other malignancies within the past 5 years, excluding adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; 4.Receiving concurrent anti-tumor therapy or currently participating in another clinical trial; 5.Presence of a severe non-malignant concomitant disease that would compromise patient compliance or place the patient at unacceptable risk; 6.Major surgical procedure within 4 weeks prior to the initiation of study treatment, or anticipation of needing major surgery during the course of the study; 7.History of hypersensitivity or contraindication to any active ingredient or excipient of the study drugs; 8.Dementia, intellectual disability, or any psychiatric illness/condition that precludes the understanding of the informed consent form; 9.Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response,tpCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival,EFS;Adverse Event,AE;Objective Response Rate,ORR;Invasive Disease-Free Survival,iDFS;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactXiaoan Liu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed