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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06641544 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor treatment, anti-HER2 therapy, anti-HER2 therapy other than trastuzumab, pertuzumab, and pyrotinib disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages