...1) Patients who can voluntarily sign an informed consent form; 2) Females aged ≥18 years at the time of signing the informed consent form; 3) ECOG PS performance status score between 0 and 2; 4) Patients histologically diagnosed with HER2-positive metastatic breast cancer, with or without brain metastasis, and with locally recurrent disease that cannot undergo curative surgery or radiation therapy; 5) Patients who experience relapse or metastasis within 1 year during or after (neo)adjuvant pertuzumab-based targeted therapy, or disease progression during first-line pertuzumab-based targeted therapy in advanced stages; 6) Patients who have received ≤1 regimen of previous pertuzumab-based targeted therapy for recurrent or metastatic disease; 7) Brain metastasis patients must meet the following criteria: stable previous brain metastasis treatment, untreated brain metastasis with no immediate need for local treatment, or progressive previous brain metastasis without immediate need for local treatment; 8) Left ventricular ejection fraction (LVEF) ≥50%; 9) Blood routine examination meets the following conditions: ① absolute neutrophil count (ANC) ≥1.5×109/L, ② platelet count ≥100×109/L, ③ hemoglobin ≥90g/L, ④ white blood cell count ≥3.0×109/L; 10) Liver function meets the following conditions: ① serum total bilirubin ≤1.5×ULN, or ≤3×ULN if liver metastasis is present, ② aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if liver metastasis is present; 11) Renal function meets the following conditions: serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (creatinine clearance calculated according to the Cockcroft-Gault formula); 12) Female patients who meet the following conditions can participate in this study: ① not fertile; ② fertility potential, with a negative pregnancy test result within 7 days before the first administration of the study drug, not breastfeeding, and consistently using highly effective contraceptive measures before study enrollment, throughout the study period, and within 6 months after the last administration of the study drug....

The combination regimen of inetetamab combined with pyrotinib and vinorelbine showed an encouraging efficacy and favorable safety in patients with HER2 positive metastatic breast cancer.

The median PFS was 8.63 months (95% confidence interval [CI] 4.15 to 13.12 months). ORR was 53.3% (16/30) and DCR reached 96.7% (29/30)….The combination regimen of inetetamab plus pyrotinib plus oral vinorelbine showed an encouraging efficacy and favorable safety in patients with HER2 positive metastatic breast cancer.

This study aims to explore the effectiveness and safety of inetetamab + pyrotinib + vinorelbine for ≥second-line treatment of HER2-positive MBC….The median PFS of the second-line treatment subgroup was 17 months, the ORR and CBR were 60.0% and 86.7%, respectively, which were significantly higher than those in the ≥third-line treatment subgroup and numerically superior to T-DM1 as a second-line treatment option....Inetetamab + pyrotinib + vinorelbine demonstrates good efficacy and controllable toxicity as a second-line treatment for HER2-positive MBC.

The median PFS was 10.03 months (95% confidence interval [CI] 6.66 to 13.41 months). ORR was 62.3% (48/77) and CBR reached 77.9% (60/77)...The combination regimen of inetetamab combined with pyrotinib and vinorelbine showed an encouraging efficacy and favorable safety in patients with HER2 -positive metastatic breast cancer.

We reported the efficacy and safety from 29 pts. Partial response (PR) was achieved in 23 pts and stable disease (SD) in 4 pts, the ORR was 79.3% and DCR was 93.1%....Inetetamab plus pyrotinib and utidelone may be an excellent scheme for HER2-positive metastatic breast cancer.

The median progression‐free survival (mPFS) was 5.6 (4.6–6.6) months….Patients treated with inetetamab plus pyrotinib plus vinorelbine benefited the most (p=0.048), with the mPFS of 9.3 (3.1–15.5) months and an objective response rate of 35.5%....HER2+ MBC patients pretreated with multiple-line therapies still respond to inetetamab-based treatment. Inetetamab combined with vinorelbine and pyrotinib may be the most effective treatment regimen, with a controllable and tolerable safety profile.

The ORR and DCR were 53.5 % (24 / 45) and 86.7 % (39 / 45), respectively after 6 cycles treatment. The median PFS was 7.3 months...Inetetamab combined with pyrotinib and chemotherapy showed a promising efficacy and a good tolerance in patients with HER2-positive metastatic breast cancer, confirming the synergistic effect between the ADCC optimized monoclonal antibodies and TKIs, which brings more treatment options for HER2- positive metastatic breast cancer.