Explore the efficacy and safety of the combination of inetetamab, pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
This study is a prospective, open-label, single-arm clinical study, and it is planned to include 20 treatment-naive patients with HER2-positive early or locally advanced breast cancer (clinical stage IIA \~ IIIC). Neoadjuvant treatment regimen was inetetamab + pyrotinib + nab-paclitaxel. To explore the efficacy and safety of the combination of inetetamab,pyrotinib and nab-paclitaxel in the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pyrotinib 400 mg, qd; nab-paclitaxel 125 mg/m2, qw, D1/8/15; Inetetamab 6 mg/kg (first dose 8 mg/kg) q3w, D1; 4 cycles in total (q3w as 1 cycle). The patient's postoperative adjuvant therapy was 4 cycles of epirubicin + cyclophosphamide + physician's choice of anti-HER2 targeted therapy. Multiple drug interruptions for adverse events were allowed throughout.
First Affiliated Hospital of Fourth military medical universit
Xi'an, Shannxi, China
Pathological complete response rate (pCR)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0)
Time frame: At the end of Cycle 1 (each cycle is 14 days)
Objective response rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) as assessed per RECIST v1.1 during neoadjuvant therapy.
Time frame: During the period of neadjuvant treatment, an average of 4 weeks
adverse effects
Serious adverse effect occur within neoadjuvant treatment
Time frame: during the period of neadjuvant treatment, an average of 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.