OncoMatch/Clinical Trials/NCT06641544
The Efficacy and Safety of Different Combination Regimens of Inetetamab in First-line Treatment of HER2 Positive Metastatic Breast Cancer
Is NCT06641544 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Inetetamab for metastatic breast cancer.
Treatment: Inetetamab — This study is to explore the efficacy and safety of the first-line treatment of HER2 positive recurrent/metastatic breast cancer with Inetetamab combined with Pertuzumab or Pyrotinib combined with chemotherapy, hoping to have better clinical benefits and provide a new treatment mode for targeted treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ish positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anti-tumor treatment
Exception: excluding endocrine therapy previously performed for recurrence/metastasis stage
Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage)
Cannot have received: anti-HER2 therapy
Exception: adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
Have not received first-line anti-HER2 treatment or (new) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
Cannot have received: anti-HER2 therapy other than trastuzumab, pertuzumab, and pyrotinib
During the (new) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab, pertuzumab, and pyrotinib
Cannot have received: anti-HER2 therapy (trastuzumab)
Patients who experience disease progression during (new) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (new) adjuvant system treatment
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L; platelets ≥ 90×10^9/L; hemoglobin ≥ 90g/L
Kidney function
BUN and Cr ≤1.5×ULN
Liver function
ALT and AST ≤2.5×ULN; liver metastasis patients require ALT and AST ≤5×ULN; total bilirubin ≤1.5×ULN (Gilbert syndrome ≤2×ULN); alkaline phosphatase ≤2.5×ULN
Cardiac function
LVEF ≥50%; QTcF <470msec; no history of major heart disease or dysfunction
organ function must meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5×10^9/L; platelets (PLT) ≥ 90×10^9/L; hemoglobin (Hb) ≥ 90g/L. Blood biochemistry: total bilirubin (TBIL) ≤1.5×ULN, known as Gilbert syndrome patients, TBIL ≤ 2 × ULN; ALT and AST ≤2.5×ULN; and liver metastasis patients require ALT and AST ≤5×ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤1.5×ULN; Coagulation function: INR and APTT ≤ 1.5 × ULN, unless drugs known to alter INR and APTT are used; LVEF ≥50%; 12 lead electrocardiogram: QTcF<470msec; No history of major organs such as the heart, lungs, liver, kidneys, or endocrine system
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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