Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

NCT ID: NCT06754059

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2027-12-30

Brief Summary

A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC

Detailed Description

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; Single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with HR+, and maintenance therapy after first-line TH (P) therapy for CNS events (if non-CNS recurrent, progressive events occur and the investigator decides to change the follow-up regimen). To evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line TH (P) therapy for advanced breast cancer with HER-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.

Conditions

HER2-positive Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

pyrotinib

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period(capecitabine was used for 4-6 cycles

Pyrotinib

Intervention Type: DRUG

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles

Interventions

Pyrotinib

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 18-70 years old, female;

2. Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as >10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;

3. Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;

4. ECOG score is 0-1;

5. Expected survival ≥6 months;

6. Normal function of major organs;

7. 1) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;

8. The researcher believes that the subject is likely to benefit;

9. Voluntarily participate in the study and sign the informed consent

Exclusion Criteria

1. Head MRI or head CT confirms the presence of brain metastases;

2. Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);

3. Study patients allergic to drugs and excipients;

4. Suffering from mental illness or psychotropic substance abuse, unable to cooperate;

5. Pregnant or lactating women;

6. Participated in clinical trials within 4 weeks;

7. Participants considered unsuitable for inclusion by the researchers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

zhangjie

OTHER

Sponsor Role: lead

Responsible Party

zhangjie

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fujian Union Medical College Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Facility Contacts

zhang jie, MD

Role: primary

zjie1979@fjmu.edu.cn

18324106745

Other Identifiers

Fujian union BC-001

Identifier Type: -

Identifier Source: org_study_id