Comparing two treatments for HER2-positive breast cancer before surgery

A Non Inferior, Randomized Controlled Phase II Clinical Study Comparing the Efficacy of Nab-PH+Pyrrolitinib and TCbHP in the Neoadjuvant Treatment of HER2 Positive Breast Cancer

This study is testing a new combination of drugs to see if it works better than standard treatment for people with HER2-positive breast cancer before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 610 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, pyrrolitinib
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT05918328 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination of albumin paclitaxel, trastuzumab, and pyrrolitinib against a standard treatment of docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive breast cancer. The study aims to determine which treatment leads to a higher rate of pathologic complete response (pCR) and improved disease-free survival. Participants will be monitored for adverse reactions and overall treatment efficacy. The trial includes patients aged 18-65 with measurable HER2-positive invasive breast cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with clinically measurable HER2-positive invasive breast cancer.

Not a fit: Patients with non-HER2-positive breast cancer or those with severe comorbidities that contraindicate chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective neoadjuvant treatment option for patients with HER2-positive breast cancer, potentially improving their chances of a complete response to therapy.

How similar studies have performed: Previous studies have shown promising results with similar combinations of targeted therapies in HER2-positive breast cancer, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-65 years old, ECOG 0-1 point.
2. Clinical T2-T4d, or T1c with axillary LN+.
3. HER2+, invasive breast cancer confirmed by histopathology;(HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+or positive confirmed by fluorescence in situ hybridization \[FISH\] in the pathological test/review of the primary focus conducted by the Pathology Department of the Research Center Hospital).
4. Having clinically measurable lesions: measurable lesions displayed on ultrasound, mammography, or MR (optional) within the first month of randomization.
5. Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy:Absolute value of neutrophil count ≥ 2.0 × 109/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 109/L;Total bilirubin\<1.5 ULN (upper limit of normal value); Creatinine\<1.5 × ULN; AST/ALT \< 1.5 × ULN.
6. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%).
7. Women of childbearing age tested negative for serum pregnancy test 14 days before randomization.
8. Sign an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer.
2. Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease.
3. The patient has a second primary malignant tumor, except for fully treated skin cancer.
4. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
5. Serious heart disease or discomfort, including but not limited to the following diseases:Confirmed history of heart failure or systolic dysfunction (LVEF\<50%); High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate\>100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block; Angina pectoris requiring treatment with anti angina drugs; Clinically significant heart valve disease; ECG shows transmural myocardial infarction; Poor control of hypertension (systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>100 mmHg).
6. Due to serious and uncontrollable other medical diseases, researchers believe that there are contraindications to chemotherapy.
7. Individuals with a known history of allergies to the drug components of this protocol; Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.

Where this trial is running

Zhengzhou, Henan

• Henan cancer hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Zhenzhen Liu — Study Principal Investigator
• Study coordinator: Zhenzhen Liu

Conditions Breast Cancer; HER2-positive Breast Cancer; pathologic complete response; Pyrrolitinib; Disease-free survival