A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Recruiting now · Phase 3
Conditions studied: Breast Cancer,HER2-positive
In brief
The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
Key facts
- Study ID
- NCT04547907
- Run by
- Henan Cancer Hospital
- People needed
- 688
- Starts
- 2020-09-18
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-09-20
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age: 18-70 years;
- Clinical T2-T4d, or T1c with axillary lymph node positivity;
- Histopathologically confirmed HER2-positive invasive breast cancer; Note: HER2 positivity was determined by immunohistochemical (IHC) staining of 3+ or, if IHC 2+, by HER2 gene amplification as demonstrated by fluorescence in situ hybridization (FISH) assay；
- Have clinically measurable lesions: Measurable lesions shown on ultrasound, mammography, or MR (optional) within 1 month before randomization;
- No chemotherapy contraindications detected by organ and bone marrow function tests within 1 month before chemotherapy:
- Neutrophil count absolute value ≧2.0×109/L;
- Hemoglobin ≧ 100g/L;
- Platelet count ≧100×109/L;
- Total bilirubin <1.5 ULN (upper limit of normal);
- Creatinine < 1.5×ULN
- AST/ALT < 1.5×ULN;
- Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 55%);
- Reproductive age women, negative serum pregnancy test within 14 days before randomization;
- ECOG score 0 or 1;
- Signature of informed consent.
You may not qualify if…
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Patients who have received chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this disease;
- Patients with a second primary malignancy, except for adequately treated skin cancer;
- Major non-breast cancer-related surgical procedures within the past 4 weeks before enrollment, or patients have not fully recovered from such surgical procedures;
- Severe heart disease or conditions that do not allow participation in the study, including but not limited to the following:
- 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-grade atrioventricular conduction blocks (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);
- Angina pectoris requiring anti-anginal drug therapy;
- Clinically significant valvular heart disease;
- ECG showing a transmural myocardial infarction;
- Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg);
- Due to severe and uncontrolled other medical conditions, the investigator considers chemotherapy to be contraindicated;
- Known history of allergy to any component of the study drugs; patients with a history of immune deficiency diseases, including HIV positivity, or patients with other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
Where it is running
- Henan cancer hospital — Zhengzhou, Henan, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.