Combination therapy for HER2-positive breast cancer

Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

This study is testing a new combination of treatments for women with HER2-positive breast cancer to see if it helps them respond better to therapy before surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Fujian Medical University (Academic / other)
• Drugs / interventions: trastuzumab, pyrotinib, chemotherapy
• Locations: 1 site (Fuzhou, Fujian)
• Trial ID: NCT06035679 on ClinicalTrials.gov

What this trial studies

This clinical trial is an observational study that aims to evaluate the efficacy of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy in treating HER2-positive breast cancer. It will enroll 30 female patients with early to locally advanced stages of the disease. The primary endpoint is to assess the total pathological complete response rate (tpCR) following treatment. The study also seeks to observe the effectiveness of a step-down neoadjuvant therapy approach for specific early-stage breast cancer patients.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-75 with HER2-positive breast cancer at early to locally advanced stages.

Not a fit: Patients with non-HER2-positive breast cancer or those with advanced metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve the response rates in patients with HER2-positive breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies for HER2-positive breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-75 years;
2. Her2-positive breast cancer confirmed by pathology;
3. invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
4. ECOG PS: 0-1 score;
5. Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
6. Normal function of major organs means that the following criteria are met:

(1) Blood test neutrophil (ANC) \>=1.5x10\^9/L; Platelet count (PLT) \>=90x10\^9/L; Hemoglobin (Hb) \>=90g/L; (2) Total bilirubin (TBIL) \<=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=1.5xULN; Alkaline phosphatase \<=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) \<=1.5xULN; (3) Left ventricular ejection fraction (LVEF) \>=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

Exclusion Criteria:

1. Known allergic history of the drug components of this protocol;
2. Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
3. Participated in clinical trials of other antitumor drugs within four weeks;
4. Stage IV (metastatic) breast cancer;
5. Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
6. A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);
7. Patients with active infection and severe mental illness;
8. Pregnant or lactating patients;
9. Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
10. Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

Where this trial is running

Fuzhou, Fujian

• The First Affiliated Hospital of Fujan Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: zhu youzhi

Conditions Breast Cancer Female