Using Pyrotinib for HER2-positive Breast Cancer After Trastuzumab Treatment
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer: an Open-label, Multi-center Trial
PHASE2 · Taizhou Hospital · NCT05880927
This study is testing whether a new drug called pyrotinib can help high-risk HER2-positive breast cancer patients feel better after finishing their previous treatment with trastuzumab.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Taizhou Hospital (other) |
| Drugs / interventions | trastuzumab, pyrotinib |
| Locations | 1 site (Taizhou, Zhejiang) |
| Trial ID | NCT05880927 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label phase II trial evaluates the effectiveness of pyrotinib as extended adjuvant therapy in high-risk HER2-positive breast cancer patients who have completed trastuzumab-based treatment. Participants will receive pyrotinib at a dose of 400mg per day for either one year or six months, depending on their risk factors. The study aims to determine the impact of this treatment on disease outcomes in patients who did not achieve a complete pathological response or have other high-risk features. The trial is conducted across 23 centers in China, focusing on a specific patient population with defined eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with HER2-positive breast cancer who have completed one year of trastuzumab-based therapy and are classified as high risk.
Not a fit: Patients with serious heart conditions, those unable to take the medication, or those with a history of immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for high-risk HER2-positive breast cancer patients after initial therapy.
How similar studies have performed: Other studies have explored the use of targeted therapies in HER2-positive breast cancer, indicating potential for success, but this specific approach with pyrotinib is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women aged 18-75 years old 2. HER2 positive breast cancer 3. ECOG PS 0-1 4. Known hormone receptor status 5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months 6. Patients at high risk Exclusion Criteria: 1. Serious heart disease or discomfort 2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption 3. Known allergic history of drug components of this regimen 4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation 5. Pregnant and lactating female patients
Where this trial is running
Taizhou, Zhejiang
- Taizhou Hospital — Taizhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Feilin Cao, Master — Taizhou Hospital
- Study coordinator: Feilin Cao, Master
- Email: drcfl@126.com
- Phone: 13806562998
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer