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Not yet recruiting NCT06578299

Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

Phase IV Interventional Breast Cancer Stage IV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inetetamab and Paclitaxel ± Pertuzumab.
Who it may be relevant to
Registry conditions: Breast Cancer Stage IV. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Real World Study of First Line Treatment of HER2 Positive Recurrent/Metastatic Breast Cancer With Inetetamab Combined With Paclitaxel With/Without Pertuzumab（INTPOWER）

Overview

This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

Interventions

  • Drug Inetetamab and Paclitaxel ± Pertuzumab
    Inetetamab and Paclitaxel ± Pertuzumab Inetetamab：was administered as an intravenous (IV) loading dose of 8mg/kg q3w on Day 1 of Cycle 1 (1 Cycle length = 21 days), and 6mg/kg q3w on Day 1 of subsequent cycles, until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Paclitaxel：Docetaxel 75mg/m2, albumin paclitaxel 260mg/m2, or paclitaxel liposomes 175mg/m2) is administered intravenously on the first day of every three weeks, until i

Primary outcome measures

  • PFS [Time frame: Until progression, assessed up to approximately 24 months]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: Until progression, assessed up to approximately 24 months]
  • Clinical Benefit Rate (CBR) [Time frame: Until progression or death, assessed up to approximately 24 months]
  • Overall Survival (OS) [Time frame: Up to approximately 3 years]
  • Number of Participants With Adverse Events (AEs) [Time frame: Up to approximately 3 years]

Eligibility criteria

Inclusion criteria

  • Age 18 - 70 years, female
  • Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive
  • Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease
  • Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months
  • Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;
  • ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;
  • The cardiopulmonary function is basically normal, with LVEF ≥ 50%;
  • Adequate organ function;
  • Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；
  • The patient voluntarily signs an informed consent form.

Exclusion criteria

  • Participated in other clinical trials within 4 weeks;
  • Have received any systematic anti-tumor treatment during the recurrence/metastasis stage (excluding endocrine therapy previously performed for recurrence/metastasis stage);
  • During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;
  • Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence/metastasis within 12 months after completing (neo) adjuvant system treatment;
  • Evidence of central nervous system metastasis or leptomeningeal disease;
  • Individuals with a known history of allergies to the components of this medication regimen;
  • Pregnant or lactating women;
  • Left ventricular ejection fraction<50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;
  • The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06578299 · INTPOWER

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗