Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

A Single Arm，Multicenter，Real-world Observational Study of Pyrotinib Plus Trastuzumab After First-line TH (P) Treatment With HER-2 Positive Breast Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05255523

Enrollment

Registered

2022-02-24

Start date

2022-02-20

Completion date

2024-12-20

Last updated

2022-02-24

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

Conditions

Advanced Breast Cancer

Keywords

pyrotinib;CNS;breast cancer; HER-2 positivity

Brief summary

The purpose of this study is to assess the effect of pyrotinib

Detailed description

The purpose of this study is to assess the effect of pyrotinib combined with trastuzumab in the maintenance phase delay/reduction of brain metastases after first-line TH(P) therapy for HER-2-positive advanced breast cancer

Interventions

DRUGpyrotinib

After 4-6 cycles of taxane chemotherapeutics combined with trastuzumab±pertuzumab, the assessment result reaches CR or PR, and the subsequent sequential pyrrotinib plus capecitabine±trastuzumab to CNS Progress

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. age:18-75 years old, female; 2. HER2 positive advanced breast cancer diagnosed by pathology, cytology or radiology, including inoperable breast cancer with stage IV, or recurrent/metastatic breast cancer.HER-2 positivity was confirmed by histopathological test: immunohistochemistry(IHC) results of 3 + or in situ hybridization (ISH) results of amplification of HER2; 3. Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 5. Life expectancy greater than or equal to 6 months; 6. The main organs function well, and the inspection indicators meet the following requirements: 1\) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALT and AST≤2×ULN, but≤5×ULN if the transferanse elevation is due to liver metastases； TBIL≤1.5×ULN； Serum creatinine ≤1.5×ULN; 7. The researchers believed that the subjects were preference to benefit; 8. Participants were willing to join in this study, and written informed consent.

Exclusion criteria

1. Patients with brain metastases by CT or MRI; 2. More factors affecting of oral drugs (gastrointestinal surgery history, inability to swallow, chronic diarrhea, intestinal obstruction); 3. Study drug and excipient allergy; 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Pregnant or lactating female patients; 6. Less than 4 weeks from the last clinical trial; 7. The researchers think inappropriate.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of first progression with brain metastases	24 month	Incidence of first progression with brain metastases

Secondary

Measure	Time frame	Description
ORR without CNS	24 month	Baseline to measured stable disease without central nervous system
TTBM	24 month	Time to brain metastases

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026