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CompletedNCT05839288Updated May 3, 2023

Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

An observational study in Breast Cancer, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
161
Ages
18 Years and older
Sex
Female
01

Study summary

To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Pyrotinib
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 161 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Inclusion criteria

  • woman, age > 18 years old
  • diagnosed with HER2 +Metastatic Breast Cancer
  • received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09
  • available medical history

Exclusion criteria

Exclusion Criteria:

  • medical history was incomplete
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • PyroHC

    Patients used pyrotinib (Pyro) plus trastuzumab (H) and chemotherapy (C) as treatment for metastatic breast cancer.

06

What researchers measure

Primary outcomes

  1. progression-free survival (PFS)

    Progression free survival

    Time frame: 6 weeks

Secondary outcomes

  1. Adverse events

    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

    Time frame: 6 weeks

07

Study locations

1 site
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05839288
Lead sponsor
Fudan University
Responsible party
Biyun Wang, MD (Professor, Fudan University) — Principal investigator
First posted
May 3, 2023
Start date
Nov 1, 2022
Primary completion
Mar 1, 2023
Completion
Apr 1, 2023
Last update
May 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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