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Compares treatment options for Breast Cancer
Official title Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
ClinicalTrials.gov ID: NCT07057427
What this study is testing
What is Nab paclitaxel?
Nab paclitaxel is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to evaluate the efficacy of nab-paclitaxel (on days 1 and 8 of a 21-day cycle) compared to the standard regimen of docetaxel plus carboplatin, both combined with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age: 18-70 years old. Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity. Histologically confirmed HER2-positive invasive...
- Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
- Hemoglobin ≥ 100 g/L
- Platelet count ≥ 100 × 10⁹/L
- Total bilirubin \< 1.5 × upper limit of normal (ULN)
You likely can't join if
- Stage IV (metastatic) breast cancer. Bilateral breast cancer. Prior systemic therapy or radiotherapy for the current breast cancer diagnosis...
- History of congestive heart failure or systolic dysfunction (LVEF \< 50%)
- High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate \> 100 bpm, clinically significant ventricular arrhythmia [e.g...
- Angina pectoris requiring anti-anginal medication
- Clinically significant valvular heart disease
- Electrocardiogram (ECG) evidence of transmural myocardial infarction
See the full eligibility criteria
- Age: 18-70 years old. Clinical Tumor Stage: T2-T4d, or T1c with axillary lymph node positivity. Histologically confirmed HER2-positive invasive breast cancer: Note: HER2 positivity is defined as at least one assessment...
- Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
- Hemoglobin ≥ 100 g/L
- Platelet count ≥ 100 × 10⁹/L
- Total bilirubin \< 1.5 × upper limit of normal (ULN)
- Serum creatinine \< 1.5 × ULN
- Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) \< 1.5 × ULN Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55% assessed by echocardiography. Women of childbearing potential: Negative...
- Stage IV (metastatic) breast cancer. Bilateral breast cancer. Prior systemic therapy or radiotherapy for the current breast cancer diagnosis, including chemotherapy, endocrine therapy, or targeted therapy. History of a...
- History of congestive heart failure or systolic dysfunction (LVEF \< 50%)
- High-risk uncontrolled arrhythmias (e.g., atrial tachycardia, resting heart rate \> 100 bpm, clinically significant ventricular arrhythmia [e.g., ventricular tachycardia], or higher-grade atrioventricular block [i.e...
- Angina pectoris requiring anti-anginal medication
- Clinically significant valvular heart disease
- Electrocardiogram (ECG) evidence of transmural myocardial infarction
- Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) Presence of any other severe, uncontrolled medical condition that, in the investigator's judgment...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.