NCT06754059 Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC
| NCT ID | NCT06754059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | zhangjie |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-06-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Frequently Asked Questions
Who can join the NCT06754059 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06754059 currently recruiting?
Yes, NCT06754059 is actively recruiting participants. Visit ClinicalTrials.gov or contact zhangjie to inquire about joining.
Where is the NCT06754059 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06754059 clinical trial?
NCT06754059 is sponsored by zhangjie. The trial plans to enroll 60 participants.
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