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A real-world study on the efficacy and safety of pyrotinib in the treatment of HER-2 positive metastatic breast cancer

A real-world study on the efficacy and safety of pyrotinib in the treatment of HER-2 positive metastatic breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038163
Enrollment
Unknown
Registered
2020-09-11
Start date
2020-09-10
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Case series:Nil

Sponsors

Shandong Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. For patients with stage IV HER-2 positive breast cancer confirmed by histopathology as recurrence and metastasis or inoperable at the time of diagnosis, HER-2 positive breast cancer was defined as primary or metastatic foci, and HER-2 positive tissue samples were 3 + by immunohistochemistry or + by fluorescence in situ hybridization (FISH); 2. Patients aged 18-80 years; 3. According to the response evaluation criteria in solid tumors (RECIST 1.1), patients with at least one measurable lesion; 4. The ECoG score of physical fitness was less than 2; 5. Patients with an estimated survival time of more than 3 months; 6. In patients with normal function of important organs, blood routine examination and liver and kidney function examination before chemotherapy were basically normal, without treatment contraindications.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients who cannot understand this study or fail to sign an informed consent form; 3. No traceable medical record available; 4. Other patients who are not suitable for this study under investigators' consideration.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;Adverse Events;

Secondary

MeasureTime frame
Overall Survival;Objective Response Rate;Duration of Response;Clinical Benefit Rate;Quality of Life;Compliance;

Countries

China

Contacts

Public ContactHuihui Li

Shandong Cancer Hospital and Institute

15553103209@163.com+86 15553103209

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026