Using pyrotinib and trastuzumab for maintenance therapy in HER2-positive breast cancer

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

This study is testing if using the drugs pyrotinib and trastuzumab together can help people with advanced HER2-positive breast cancer stay healthier and prevent brain tumors after their initial treatment.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fujian Medical University Union Hospital (other)
• Drugs / interventions: trastuzumab, pyrotinib, pertuzumab, pyrrotinib, chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06754059 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of pyrotinib combined with trastuzumab as maintenance therapy following first-line taxoid chemotherapy and trastuzumab for patients with HER2-positive advanced breast cancer. Participants will have received at least four cycles of initial treatment and will be monitored for the incidence of brain metastases as a primary endpoint. The study aims to assess the impact of this combination therapy on delaying disease progression and managing brain metastases. It involves multiple centers and focuses on real-world outcomes in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with confirmed HER2-positive invasive breast cancer who have experienced recurrence or metastasis more than one year after trastuzumab treatment.

Not a fit: Patients with HER2-negative breast cancer or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve maintenance therapy outcomes and reduce the incidence of brain metastases in patients with HER2-positive breast cancer.

How similar studies have performed: While there have been studies on HER2-targeted therapies, the specific combination of pyrotinib and trastuzumab in this maintenance context is relatively novel.

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.

Where this trial is running

Fuzhou, Fujian

• Fujian Union Medical College Hospital — Fuzhou, Fujian, China (RECRUITING)

Conditions: HER2-positive Breast Cancer