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

Advanced Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05255523
• Other study ID #: 001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 20, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: February 2022
• Source: Fujian Medical University Union Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 20, 2024
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• pyrotinib
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of first progression with brain metastases	Incidence of first progression with brain metastases	24 month
Secondary	ORR without CNS	Baseline to measured stable disease without central nervous system	24 month
Secondary	TTBM	Time to brain metastases	24 month