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

NCT ID: NCT06990347

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

301 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inetetamab and Pyrotinib Combined with Chemotherapy

Inetetamab and Pyrotinib Combined with Chemotherapy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fan Wu

Associate Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fujian Cancer Hospital

Fuzhou, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K2024-534-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pyrotinib in HER2-positive Early Breast Cancer
NCT06718335 NOT_YET_RECRUITING NA