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OpenTrials
Completed

NCT Number: NCT06990347

A Study on the Efficacy and Safety of IPyC for HER2+ MBC

Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity. Efficacy endpoints included progression-free survival (PFS), objective response rate (ORR), and clinical benefit rate (CBR).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Fujian Cancer Hospital

Fuzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who underwent a biopsy of the metastatic site and were confirmed as having MBC
  • patients who received inetetamab + pyrotinib + chemotherapy as metastasis therapy.

Exclusion criteria

  • male patients or individuals with prior malignancy
  • patients with prior or current enrollment in interventional clinical trials for MBC
  • patients who received less than 2 cycles of treatment (6 weeks of inetetamab or 8 weeks of pyrotinib)
  • patients who were lost to follow-up during the therapeutic process

Treatment and study plan

Inetetamab and Pyrotinib Combined with Chemotherapy

Drug

Inetetamab and Pyrotinib Combined with Chemotherapy

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: 2 years

Secondary outcomes

  1. objective response rate (ORR)

    Time frame: 2 years

  2. clinical benefit rate (CBR)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

A Retrospective Multicenter Cohort Study on the Efficacy and Safety of Inetetamab and Pyrotinib Combined With Chemotherapy for HER2-positive Metastatic Breast Cancer

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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