This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg/kg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.
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).
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.
Single group
Trastuzumab Rezetecan
DrugAn anti-HER2 antibody-drug conjugate (ADC) consisting of a humanized HER2-targeting monoclonal antibody (trastuzumab) conjugated to a DNA topoisomerase I inhibitor (SHR169265) via a cleavable tetrapeptide linker.
Total Pathological Complete Response (tpCR)
Absence of invasive residual cancer in both the breast primary tumor and axillary lymph nodes (ypT0/is, ypN0) after neoadjuvant therapy and surgery. Presence of ductal carcinoma in situ (DCIS) is allowed.
Event-Free Survival (EFS)
Time from first dose of study treatment to the earliest occurrence of any of the following: disease progression (per RECIST 1.1), local/regional/distant recurrence, second primary tumor (breast or other), or death from any cause.
Overall Survival (OS)
Time from first dose of study treatment to death from any cause.
3-Year Invasive Disease-Free Survival (iDFS) Rate
Percentage of patients who are free from invasive disease at 3 years after surgery. Invasive disease events include ipsilateral invasive breast tumor recurrence, local/regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, or death from any cause.
Incidence of Adverse Events (AEs)
Number of participants experiencing adverse events. AEs are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
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