Nab-Paclitaxel for Early HER2-positive Breast Cancer
Efficacy of Nab-PHP Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
812 (estimated)
Sponsor
Henan Cancer Hospital · Government
Who this trial is looking for
This trial is looking for women with early-stage HER2-positive breast cancer to see how well nab-paclitaxel works compared to standard treatments. Participants will receive treatments and be monitored for their health during the trial.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with HER2-positive invasive breast cancer.
I have measurable disease confirmed by ultrasound or MRI.
My organs are functioning well for chemotherapy.
My heart function is healthy.
I am able to give signed consent to participate.
You may not be able to join if
I have stage IV breast cancer.
I have had a different cancer besides non-melanoma skin cancer.
I have had previous treatment for my current breast cancer.
I have had major surgery in the last 4 weeks.
I have significant heart disease or dysfunction.
I have a severe uncontrolled medical condition.
I am allergic to any study drug.
I have a history of immune deficiency or organ transplantation.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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 (either initial testing or central review) by the partici…
Inclusion 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 (either initial testing or central review) by the participating center's pathology department demonstrating tumor cells with immunohistochemistry (IHC) staining intensity of 3+ or confirmation by fluorescence in situ hybridization (FISH).
Clinically measurable disease: Lesion measurable by ultrasound or MRI (optional) within 1 month prior to randomization.
Adequate organ and bone marrow function within 1 month prior to chemotherapy initiation (no contraindications to chemotherapy):
1. Absolute neutrophil count (ANC) ≥ 2.0 × 10⁹/L
2. Hemoglobin ≥ 100 g/L
3. Platelet count ≥ 100 × 10⁹/L
4. Total bilirubin \< 1.5 × upper limit of normal (ULN)
5. Serum creatinine \< 1.5 × ULN
6. 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 serum pregnancy test within 14 days prior to randomization.
Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Informed consent: Provision of signed written informed consent.
Exclusion Criteria:
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 second primary malignancy, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from prior major surgery.
Significant cardiac disease or dysfunction, including but not limited to:
1. History of congestive heart failure or systolic dysfunction (LVEF \< 50%)
2. 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 \[i.e., Mobitz II second-degree or third-degree heart block\])
3. Angina pectoris requiring anti-anginal medication
4. Clinically significant valvular heart disease
5. Electrocardiogram (ECG) evidence of transmural myocardial infarction
6. 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, constitutes a contraindication to chemotherapy.
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.
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