HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Have at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
No prior history of breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy.
Disqualifiers
Male breast cancer or inflammatory breast cancer.
Metastatic breast cancer (Stage IV).
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.
Receiving concurrent anti-tumor therapy or participating in any other clinical trial.
Trial design
Design model
Single group
Treatments tested in this trial
- 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
DrugAll 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.
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Oral Paclitaxel Solution Plus Subcutaneous Pertuzumab and TrastuzumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
pathological complete response (pCR) rate
Time frame
The assessment time frame is the first 6 months after study initiation.Secondary outcomes
1
safety profile, breast-conserving surgery rate
1. Safety profile of the combination regimen 2. Breast-conserving surgery rate in patients after neoadjuvant therapy 3. Long-term efficacy of the combination regimen
Time frame
The assessment time frame is the first 6 months after study initiation.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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