This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
320mg, qd
8 mg/kg first dose, then 6 mg/kg,q3w
125mg , qd,d1-21, q4w
2.5mg,qd
840 mg first dose, then 420 mg, q3w
75 mg/m2, q3w
AUC 6, q3w
Every 4 weeks for 5 cycles, premenopausal patients only
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGPathologic Complete Response Rate (tpCR: ypT0-is/ypN0)
Proportion of patients without any residual invasive cancer in pathological assessment of hematoxylin and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples following completion of neoadjuvant therapy and surgery
Time frame: 3 years
Best overall response
Proportion of patients with tumor response at any time during the study
Time frame: 3 years
Breast Pathologic Complete Response Rate (bpCR: ypT0-is)
Proportion of patients without any residual invasive carcinoma in pathological assessment of hematoxylin and eosin stained resected breast cancer samples following completion of neoadjuvant therapy and surgery.
Time frame: 3 years
Residual cancer burden (RCB)
RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery
Time frame: 3 years
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