Using Pyrrolitinib Maleate for HER-2-Positive Breast Cancer After Trastuzumab

A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy

This study is testing if pyrrolitinib maleate can help people with HER-2-positive breast cancer who have already been treated with trastuzumab to stay cancer-free longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Zunyi Medical College (Academic / other)
• Drugs / interventions: trastuzumab, pyrrolitinib, lenatinib, lapatinib, piretinib
• Locations: 1 site (Zunyi, Guizhou)
• Trial ID: NCT06470347 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of pyrrolitinib maleate tablets in treating patients with HER-2-positive early or locally advanced breast cancer who have previously undergone adjuvant therapy with trastuzumab. The primary objective is to assess invasive disease-free survival, while secondary objectives include overall survival, disease-free survival, distant metastasis-free survival, and safety. Eligible participants are those aged 18-75 with confirmed HER-2 positivity and no residual invasive cancer after surgery. The study aims to provide real-world evidence on the efficacy and safety of this treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with early or locally advanced HER-2-positive breast cancer who have completed trastuzumab therapy.

Not a fit: Patients with metastatic disease or those who have not undergone surgical treatment for their breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and disease management for patients with HER-2-positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar treatment approaches for HER-2-positive breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Age: 18-75 years;
* Invasive breast cancer with clinical stage 0-III and treated surgically;
* Histopathologically confirmed HER-2 positivity: immunohistochemistry (IHC) result of 3+ or in situ hybridization (ISH) result of HER-2 gene amplification (HER-2/CEP17 ≥ 2.0 or average HER-2 copy number/cell ≥ 6);
* Have undergone radical mastectomy or breast-conserving surgery for breast cancer, with no cancer left in the body and no recurrence of metastatic disease after surgery:

  1. Pathologic test confirms that there is no residual invasive cancer at the margins and no residual ductal carcinoma in situ;
  2. Patients who have not received neoadjuvant therapy should have negative surgical margins, and there is no requirement for the presence of lymph node metastasis (including the presence of lymph node micrometastasis) suggested by postoperative pathological tests;
  3. Patients receiving neoadjuvant therapy are not allowed to have postoperative pathologic evidence of invasive carcinoma in the breast or axillary lymph nodes;
* Previous trastuzumab anti-HER-2 therapy: completion of ≥24 weeks (8 dosing cycles) of trastuzumab in the neoadjuvant and/or adjuvant phases; the interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year.
* Known hormone receptor status (ER/PR);
* ECOG score of 0-1;

Normal function of major organs:

1. Blood count:

   Neutrophils (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥90×109/L; Hemoglobin (Hb) ≥90 g/L;
2. Blood biochemistry:

   Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;
3. Cardiac ultrasound:

   Left ventricular ejection fraction (LVEF) ≥55%;
4. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec.

   * For female patients who are not menopausal or surgically sterilized: consent to abstinence or use of an effective non-hormonal pharmacologic method of contraception for the duration of treatment and for 8 weeks after the last dose of study treatment;
   * Benefit in the opinion of the investigator;
   * Voluntarily participate in the study by signing an informed consent form.

Exclusion Criteria:

* Confirmed local/regional recurrence/metastasis at enrollment;
* Prior anti-HER-2 therapy with pyrrolitinib, lenatinib, lapatinib and other tyrosine kinase inhibitors;
* History of gastrointestinal disease with diarrhea as the primary symptom;
* Psychiatric illness or psychotropic substance abuse that prevents cooperation;
* Female patients who are pregnant or breastfeeding;
* Those who, in the opinion of the investigator, are not suitable for enrollment.

Where this trial is running

Zunyi, Guizhou

• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)

Study contacts

• Study coordinator: junyuan LV, Doctor of Medicine

Conditions HER-2 Positive Advanced Breast Cancer