Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer
NCT Number: NCT06513364
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Breast Cancer
Interventions: DRUG: WH002|DRUG: paclitaxel injection
Sponsor: Beijing Wehand-Bio Pharmaceutical Co., Ltd
Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-10-31
Locations: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing, 100021, China

Summary:
The purpose of this study is to compare the safety and efficacy of bi-weekly WH002(Paclitaxel Medium and Long Chain Fat Emulsion Injection,Cholesterol Bound) vs Paclitaxel both followed by bi-weekly Epirubicin and Cyclophosphamide as neoadjuvant treatment in women with HER2-negative breast cancer.

Primary Outcome Measures: All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events during the treatment period., A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported.Compare the safety and tolerability between the WH002 group and the Paclitaxel® group during the treatment period. Patients will be assessed for adverse events by clinical examination, questioning for symptoms of toxicity, laboratory assessments, vital signs, ECG and LVEF.

Neurological toxicity and other toxicities will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 5.0., From the first administration of the medication until 28 days after the breast cancer surgery, or 28 days after the last administration of the medication.
Secondary Outcome Measures: pathologic Complete Response(pCR) Rate, Comparison of the overall pathological complete response rate (tpCR, defined as ypT0/ypTis ypN0) between the WH002 group and the Paclitaxel® group;, the duration of 28 days of Postoperative of Breast Cancer；|pathologic Complete Response (pCR) and Breast Pathological Complete Response Rate(bpCR ), Comparison of the rates of pCR defined as ypT0 ypN0 and bpCR (ypT0/Tis) between the WH002 group and the Paclitaxel® group;, the duration of 28 days of Postoperative Breast Cancer；|objective response rate(ORR), Comparison of the objective response rate (ORR) assessed by ultrasound, mammography or MRI after paclitaxel treatment and sequential EC treatment between the WH002 group and the Paclitaxel® group;, At the end of Cycle 2 (each cycle is 14 days)； At the end of Cycle 4 (each cycle is 14 days)；At the end of Cycle6 (each cycle is 14 days)；At the end of Cycle 8 (each cycle is 14 days)；|time to peak concentration (Tmax), Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., the 1th day and 2th day of cycle 1 (each cycle is 14 days)，the 1th day and 2th day of cycle 4 (each cycle is 14 days)；|peak concentration (Cmax), Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；|AUC0-inf, area under the concentration-time curve from time zero to the infinity. Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；|AUC0-t, area under the concentration-time curve from time zero to the last measurable .Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；|half-life (t½), Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；|clearance (CL), Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；|free fraction, ratio of free paclitaxel concentration to total paclitaxel concentration. Comparison of pharmacokinetic parameters of total and unbound paclitaxel between the WH002 group and the Paclitaxel® group following drug administration., cycle 1（14 days）and cycle 4（14 days）；