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

• Status: Not yet recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University Union Hospital
• Treatments: Capecitabine

Criteria

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.