Oral Paclitaxel Solution Combined With Subcutaneous Pertuzumab and Trastuzumab for Neoadjuvant Treatment of HER2-Positive Breast Cancer：A Multicenter, Single-Arm, Phase 2 Clinical Study
| Registry | NCT07848633 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 65 (Estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University (Other) |
| Conditions | HER 2 Positive Advanced Breast Cancer |
| Interventions | - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles (Drug) |
| Dates | start 2026-10-01 (estimated), primary completion 2029-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2026-09-30, last updated 2026-09-30 |
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All trials for HER 2 Positive Advanced Breast Cancer All trials of - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles
1. The primary goal of this clinical trial is to evaluate the pathological complete response (pCR) rate of oral paclitaxel solution combined with subcutaneous pertuzumab and trastuzumab in the neoadjuvant treatment of early or locally advanced HER2-positive breast cancer.This trial also aims to evaluate the safety profile, breast-conserving surgery rate after neoadjuvant therapy, and long-term efficacy of this combination regimen.
2. Study Interventions
All enrolled patients will receive neoadjuvant combination treatment for 6 cycles (21 days per cycle) as follows:
* Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, for a total of 6 cycles.
* Subcutaneous pertuzumab and trastuzumab fixed-dose combination: Administered subcutaneously on Day 1 of each cycle for 6 cycles. The loading dose is 15 mL (1200 mg pertuzumab + 600 mg trastuzumab), and the maintenance dose is 10 mL (600 mg pertuzumab + 600 mg trastuzumab).
After surgery, the subsequent adjuvant treatment will be determined by the investigator based on pathological response status and the latest clinical guidelines.
3. Participant Procedures (Consistent with Provided Example Structure)
The main questions this study aims to answer are:
* Does oral paclitaxel solution combined with subcutaneous dual HER2 blockade improve the pCR rate in patients with HER2-positive early or locally advanced breast cancer?
* What are the safety profiles and tolerability of this oral chemotherapy plus subcutaneous targeted combination regimen?
* Can this regimen improve breast-conserving surgery rate and provide favorable long-term survival outcomes?
4. Participants will:
* Take oral paclitaxel solution and receive subcutaneous dual-target injection per study schedule for 6 neoadjuvant cycles
* Complete regular on-site clinic visits, physical examinations, and laboratory tests throughout the treatment period
* Undergo standardized pathological evaluation after neoadjuvant therapy and receive subsequent surgical treatment
* Accept long-term follow-up for survival status and adverse event monitoring
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Oral Paclitaxel Solution Plus Subcutaneous Pertuzumab and Trastuzumab | Experimental | Drug: - Oral paclitaxel solution: 200 mg/m² orally twice daily on Day 1 and Day 8 of each cycle, subcutaneous pertuzumab and trastuzumab fixed-dose combination for a total of 6 cycles |
Sex: Female, ages: 18 Years to any
Inclusion Criteria: 1. Aged ≥ 18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and reliable contraception must be used throughout the study treatment period. 2. Histopathologically confirmed invasive breast cancer, staged as stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system, with HER2 (3+) confirmed by immunohistochemistry. 3. Have at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). 4. No prior history of breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. Voluntarily sign and date the written informed consent form. 7. Adequate organ function meeting the following laboratory criteria: hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5×10⁹/L, platelet count ≥ 100×10⁹/L, neutrophil count ≥ 1.5×10⁹/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 1.5× ULN; serum creatinine ≤ 1.5× ULN. 8. No myocardial ischemia on electrocardiogram (ECG); New York Heart Association (NYHA) cardiac function class I; left ventricular ejection fraction (LVEF) ≥ 55% on echocardiography; cardiac biomarkers including cardiac troponin I (cTnI) and B-type natriuretic peptide (BNP) within normal reference ranges. 9. Complete all required baseline laboratory and radiological examinations prior to neoadjuvant treatment initiation. 10. No difficulty in swallowing. 11. Complete and available clinical medical records. Exclusion Criteria: 1. Male breast cancer or inflammatory breast cancer. 2. Metastatic breast cancer (Stage IV). 3. Concurrent malignancy or a history of any other malignant tumor within the past 5 years, except for adequately treated and controlled basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ. 4. Receiving concurrent anti-tumor therapy or participating in any other clinical trial. 5. Presence of severe non-malignant diseases that may affect patient compliance or pose potential safety risks. 6. Underwent major surgery within 4 weeks prior to study treatment initiation or planned to receive major surgery during the study period. 7. Received breast cancer-related radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major breast surgery within 4 weeks before treatment initiation; have current or prior exposure to HER2-targeted monoclonal antibodies or tyrosine kinase inhibitors (TKIs), including trastuzumab, pertuzumab, pyrotinib, neratinib, and lapatinib. 8. History of allergic reactions or contraindications to any component of the study drugs. 9. Presence of chronic diarrhea, intestinal obstruction, or any other disease that may affect drug administration and absorption. 10. Uncontrolled cardiac diseases or clinical symptoms, including NYHA class II or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention. 11. Dementia, cognitive impairment, or any psychiatric disorder that hinders the understanding and signing of informed consent.