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Real-world study for pyrotinib in the treatment of HER2-positive advanced breast cancer

Real-world study for pyrotinib in the treatment of HER2-positive advanced breast cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023152
Enrollment
Unknown
Registered
2019-05-14
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

Breast cancer

Interventions

Sponsors

The Third Hospital of Nanchang
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =70 years, women; 2. HER2-positive advanced breast cancer patients diagnosed by pathology or histology; 3. The main viscera function of patients must be normal, and should meet the following requirements: 1) Echocardiography:LVEF=55%; 2) Twelve lead electrocardiogram:QTcF)< 470 msec; 4. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1; 5. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure; 6. The researchers reckon that patients can benefit.

Exclusion criteria

Exclusion criteria: 1. Female patients during pregnancylactation or were positive after baseline pregnancy test; 2. The following several factors ,such as unable to swallow, chronic diarrhea and intestinal obstruction; 3. Was allergic to the study drug or any of its excipients, including HIV positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 4. Any other condition that the investigator believes not suitable for the study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;Incidence of brain metastasis;DCR;

Countries

China

Contacts

Public ContactHong Wang

The Third Hospital of Nanchang

569267018@qq.com+86 13077933598

Outcome results

None listed

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