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NCT05839288 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05839288
Other study ID # YOUNGBC-26
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date April 1, 2023

Study information
Verified date April 2023
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date April 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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: - medical history was incomplete

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary progression-free survival (PFS) Progression free survival 6 weeks
Secondary 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) 6 weeks
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