Treatment for locally advanced HER2-positive breast cancer using a combination of drugs

A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer

This study is testing a new combination of drugs to see if it can help women with locally advanced HER2-positive breast cancer get better before surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Wenzhou Medical University (other)
• Drugs / interventions: immunotherapy, Inetetamab, Pyrotinib
• Locations: 1 site (Wenzhou, Zhejiang)
• Trial ID: NCT06234137 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination treatment involving docetaxel, carboplatin, Inetetamab, and Pyrotinib in women with locally advanced HER2-positive breast cancer. Participants will receive six cycles of this treatment before surgery, with the primary goal of achieving a pathologically confirmed complete response. The study will also assess long-term outcomes such as event-free survival and overall survival, as well as potential cardiotoxicity associated with the treatment. The trial is designed to gather data from multiple centers to enhance the reliability of the findings.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18-75 with histologically confirmed locally advanced HER2-positive breast cancer.

Not a fit: Patients with early-stage breast cancer or those with HER2-negative tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with locally advanced HER2-positive breast cancer.

How similar studies have performed: While there have been studies on HER2-positive breast cancer treatments, this specific combination approach is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-75 years old;
2. ECOG score 0-1;
3. Breast cancer meets the following criteria: Histologically confirmed invasive breast cancer, primary tumor diameter \> 2 cm as determined by standard evaluation methods at the research center; tumor stage: locally advanced;
4. HER2 expression-positive breast cancer confirmed by pathological examination;
5. Known hormone receptor status (ER and PR);
6. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of white blood cell and platelet-raising drugs):

(1) Blood routine: neutrophil (ANC) \>= 1.5×10\^9/L; platelet count (PLT) \>= 90×10\^9/L; hemoglobin (Hb) \>= 90 g/L; (2) Blood biochemistry: total bilirubin (TBIL) \<= upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 1.5×ULN; alkaline phosphatase \<= 2.5×ULN; urea nitrogen (BUN) and creatinine (Cr) \<= 1.5×ULN; (3) Echocardiography: left ventricular ejection fraction (LVEF) \>= 60%; (4) 12-lead ECG: Fridericia-corrected QT interval (QTcF) \< 470 msec; 7. Female patients who are not menopausal or surgically sterilized: agree to abstain from sex or use effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria:

1. IV (metastatic) breast cancer;
2. Received anti-tumor therapy or radiotherapy for any malignant tumor in the past, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma and other malignant tumors;
3. Receiving anti-tumor therapy in other clinical trials at the same time, including endocrine therapy, bisphosphonate therapy or immunotherapy;
4. Received major surgical operations unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical operations;
5. Severe cardiac disease or discomfort, including but not limited to the following: a history of heart failure or systolic dysfunction (LVEF \< 60%); high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm , significant ventricular arrhythmia (eg, ventricular tachycardia) or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); antianginal medication indicated angina pectoris; clinically significant heart valve disease; transmural myocardial infarction on ECG; poorly controlled hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg);
6. Inability to swallow, intestinal obstruction, or other factors that affect drug taking and absorption;
7. Those who are known to have a history of allergy to the drug components of this regimen; have a history of immunodeficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;
8. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;
9. Have serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.

Where this trial is running

Wenzhou, Zhejiang

• the First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (RECRUITING)

Conditions: Breast Neoplasm Female