Clinical Research Directory

HER2-positive Breast Cancer Without Intravenous Neoadjuvant Therapy

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

Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer

The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.