This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
pyrotinib 320mg p.o. qd
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
Ruijin Hospital
Shanghai, China
RECRUITINGctDNA clearance after one cycle neoadjuvant treatment
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
Time frame: 3 months after neoadjuvant treatment initation
ctDNA clearance after two cycle neoadjuvant treatment
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Time frame: 3 months after neoadjuvant treatment initation
pCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples
Time frame: 6 months after neoadjuvant treatment initation
bpCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Time frame: 6 months after neoadjuvant treatment initation
ORR
The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).
Time frame: 6 months after neoadjuvant treatment initation
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
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docetaxel ivgtt q3w, 80-100mg/m2
Time frame: 2 years after surgery
DFS
The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause.
Time frame: 2 years after surgery
OS
Time interval from randomization to death from any cause.
Time frame: 5 years after surgery