This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Ruijin Hospital
Shanghai, China
RECRUITINGtpCR
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained of breast and lymph node samples
Time frame: From enrollment to the end of treatment at 24 weeks
bpCR
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Time frame: From enrollment to the end of treatment at 24 weeks
EFS
The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause
Time frame: through study completion, an average of 2 year
OS
Time interval from randomization to death from any cause.
Time frame: through study completion, an average of 5 year
Early ctDNA clearance
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Time frame: From enrollment to the end of treatment at 24 weeks
Late ctDNA clearance
The rate of ctDNA clearance after first four cycles of neoadjuvant treatments
Time frame: From enrollment to the end of treatment at 24 weeks
rCR
After completion of neoadjuvant therapy, no lesions presenting washout kinetic curve pattern in MRI
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pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
Time frame: From enrollment to the end of treatment at 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to the end of treatment at 24 weeks