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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Efficacy and safety of Inetetamab plus pyrotiniband and capecitabine in HER2-positive metastatic breast cancer patients with or without brain metastasis

Excerpt:
...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....
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A Multicenter, Retrospective, Real World Study of Inetetamab Combined with Pyrotinib and Vinorelbine as Treatment for HER2-positive Metastatic Breast Cancer

Published date:
12/02/2023
Excerpt:
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.
Secondary therapy:
vinorelbine tartrate
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Effectiveness and safety of inetetamab + pyrotinib + vinorelbine in ≥second-line treatment of HER2-positive metastatic breast cancer

Published date:
12/02/2023
Excerpt:
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.
Secondary therapy:
vinorelbine tartrate
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Inetetamab combined with pyrotinib and oral vinorelbine for patients with HER2-positive metastatic breast cancer: a single-arm phase 2 trial

Published date:
12/02/2023
Excerpt:
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.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

69P - A multicenter, retrospective, real-world study of inetetamab combined with pyrotinib and vinorelbine as treatment for HER2-positive metastatic breast cancer

Published date:
11/27/2023
Excerpt:
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.
Secondary therapy:
vinorelbine tartrate
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

436P - Preliminary results from a prospective study of inetetamab in combination with pyrotinib and utidelone for HER2-positive metastatic breast cancer (IPUtrial)

Published date:
10/16/2023
Excerpt:
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.
Secondary therapy:
UTD1
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of inetetamab-containing regimens in patients with HER2-positive metastatic breast cancer: a real-world retrospective study in China

Published date:
06/19/2023
Excerpt:
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.
Secondary therapy:
vinorelbine tartrate
DOI:
https://doi.org/10.3389/fonc.2023.1136380
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Inetetamab combined with pyrotinib and Chemotherapy in Pretreated Patients with HER2-positive metastatic breast cancer,a single arm,multicenter phase II clinical trial

Published date:
11/22/2022
Excerpt:
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.
Secondary therapy:
Chemotherapy