Breast Cancer
Conditions
Keywords
HER2 positive, neoadjuvant therapy, Chemotherapy de-escalation
Brief summary
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.
Interventions
DRUGNab paclitaxel
Nab-paclitaxel (on days 1 and 8 of a 21-day cycle)
Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1)
Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and pertuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) | through study completion, up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) | 5 years after surgery | — |
| Invasive Disease-Free Survival (iDFS) | 5 years after surgery | — |
| Safety-Number of adverse events and serious adverse events. | up to 1 year | — |
| Residual Cancer Burden (RCB) | up to 6 months | Proportion of patients with residual cancer burden score of 0-1 after surgery |
| EORTC QLQ-C30 score | up to 1 year | quality of life evaluated by EORTC QLQ-C30 |
| EORTC QLQ-BR23 score | up to 1 year | quality of life evaluated by EORTC QLQ-BR23 |
| Tolerability-Dose adjustment rate and withdrawal rate of chemotherapy drugs | up to 1 year | — |
Other
| Measure | Time frame |
|---|---|
| Exploratory endpoint - Differences in pCR rates between predefined subgroups and factors influencing pCR in the study population. | through study completion, an average of 1 year |
Countries
China
Contacts
Primary ContactZhenzhen Liu, PHD
Outcome results
None listed