NCT05839288

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

April 3, 2023

Last Update Submit

April 20, 2023

Conditions

Breast Cancer

Keywords

Pyrotinib

Outcome Measures

Primary Outcomes (1)

  • progression-free survival (PFS)

    Progression free survival

    6 weeks

Secondary Outcomes (1)

  • Adverse events

    6 weeks

Study Arms (1)

PyroHC

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • medical history was incomplete

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • You S, Sang D, Xu F, Luo T, Yuan P, Xie Y, Wang B. Real-world data of triplet combination of pyrotinib, trastuzumab, and chemotherapy in HER2-positive metastatic breast cancer: a multicenter, retrospective study. Ther Adv Med Oncol. 2023 Dec 23;15:17588359231217972. doi: 10.1177/17588359231217972. eCollection 2023.

    PMID: 38145113DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 3, 2023

Study Start

November 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-04

Locations

CN(1)