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

Phase 2

Not yet recruiting

• Conditions: Advanced Breast Cancer
• Interventions: Drug: pyrotinib

• Registration Number: NCT05255523
• Lead Sponsor: Fujian Medical University Union Hospital

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

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study Start: 2022-02-20
• Study First Posted: 2022-02-24
• Last Update Posted: 2022-02-24
• Primary Completion: 2023-11-05
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	pyrotinib	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.

Primary Outcome Measures

Name	Time	Method
Incidence of first progression with brain metastases	24 month	Incidence of first progression with brain metastases

Secondary Outcome Measures

Name	Time	Method
TTBM	24 month	Time to brain metastases
ORR without CNS	24 month	Baseline to measured stable disease without central nervous system