Skip to content

A real-world study of pyrrotinib maleate tablets in the treatment of HER-2 positive metastatic/recurrent breast cancer

A real-world study of pyrrotinib maleate tablets in the treatment of HER-2 positive metastatic/recurrent breast cancer

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050901
Enrollment
Unknown
Registered
2021-09-07
Start date
2021-06-01
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Breast Cancer

Interventions

Group 1:pyrrolidine combined with chemotherapy, endocrinotherapy, and radiotherapy, etc. Group 2: pyrrolidine along with trastuzumab combined with chemotherapy, endocrinotherapy , and radiotherapy, et

Sponsors

The Affiliated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer, newly diagnosed stage IV (staging based on AJCC 8th edition) or recurrent/metastatic breast cancer; 2. Histopathologically confirmed HER-2 positive: immunohistochemical (IHC) test results are 3+ or in situ hybridization (ISH) results are HER2 gene amplification (HER2/CEP17 >= 2.0 or average HER2 copy number/cell >= 6); 3. At least one measurable lesion (RECIST1.1); 4. The researcher believes that it can benefit; 5. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from mental illness or psychotropic substance abuse and cannot cooperate; 2. Pregnant or lactating patients; 3. Those who are deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Progression-free survival;Overall survival;Adverse reaction;CNS (central nervous system) metastasis;

Countries

China

Contacts

Public ContactRan Li

The Affiliated Cancer Hospital of Guizhou Medical University

ranli7215210@outlook.com+86 13984375768

Outcome results

None listed

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