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

NCT05255523 | Unknown Phase 2

• 1 other identifier: 001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Breast Cancer

Keywords

pyrotinib;CNS;breast cancer; HER-2 positivity

Outcome Measures

Primary Outcomes (1)

• Incidence of first progression with brain metastases

  Incidence of first progression with brain metastases

  24 month

Secondary Outcomes (2)

• ORR without CNS

  24 month

• TTBM

  24 month

Study Arms (1)

Arm 1

EXPERIMENTAL

Pyrotinib：400mg qd po continuous medication Capecitabine: 1000 mg/m2 bid po for 14 consecutive days with 7 days off, every 21 days as a cycle.

Drug: pyrotinib

Interventions

pyrotinib DRUG

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

Also known as: capecitabine

Arm 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age:18-75 years old, female;
• 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;
• Disease progression occurs after treatment with trastuzumab (stopping the drug for more than 12 months) or newly diagnosed IV stage breast cancer patients;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Life expectancy greater than or equal to 6 months;
• The main organs function well, and the inspection indicators meet the following requirements:
• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

MeSH Terms

Interventions

pyrotinib; Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 24, 2022
• Study Start: February 20, 2022
• Primary Completion: November 5, 2023
• Study Completion: December 20, 2024
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share