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

NCT06754059 | Recruiting

• 1 other identifier: Fujian union BC-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of brain metastases

  Incidence of brain metastases at first disease progression

  through study completion, an average of 2 year

Secondary Outcomes (3)

• ORR

  24 month

• PFS

  through study completion, an average of 2 year

• OS

  through study completion, an average of 3 year

Study Arms (1)

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

Drug: Pyrotinib

Interventions

Pyrotinib 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

pyrotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2-positive ABC

You may qualify if:

• Age: 18-70 years old, female;
• 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;
• Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
• ECOG score is 0-1;
• Expected survival ≥6 months;
• Normal function of major organs;
• \) 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%;
• The researcher believes that the subject is likely to benefit;
• Voluntarily participate in the study and sign the informed consent

You may not qualify if:

• Head MRI or head CT confirms the presence of brain metastases;
• Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
• Study patients allergic to drugs and excipients;
• Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
• Pregnant or lactating women;
• Participated in clinical trials within 4 weeks;

Sponsors & Collaborators

• zhangjie: lead

Study Sites (1)

Fujian Union Medical College Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Interventions

pyrotinib

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: June 1, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)