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COMPLETED
NCT06513364
PHASE2

Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer

Sponsor: Beijing Wehand-Bio Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: A Phase II Randomized Parallel Study of Comparing WH002 With Paclitaxel Both Sequential of Epirubicin and Cyclophosphamide As Neoadjuvant Treatment of Women With HER2-Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-09-10

Completion Date

2025-11-17

Last Updated

2026-06-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

WH002

Group A(ddWH002-ddEC): Regimen for Group A during Cycles 1-Cycles 4:WH002, 260 mg/m² administered intravenously on Day 1, with a cycle length of 2 weeks (Q2W), repeated for a total of 4 cycles. Regimen for Group A during Cycles 5-Cycles 8: • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with each cycle lasting 2 weeks (Q2W), continued for 4 consecutive cycles.

DRUG

paclitaxel injection

Group B (ddP-ddEC): Regimen for Group B during Cycles C1-C4: • Paclitaxel Injection (Paclitaxel®) 175 mg/m², administered intravenously on Day 1, with a cycle duration of 2 weeks (Q2W), repeated for a total of 4 cycles. Regimen for Group B during Cycles C5-C8: • Epirubicin Hydrochloride 90 mg/m² and Cyclophosphamide for Injection 600 mg/m², both administered intravenously on Day 1, with cycles recurring every 2 weeks (Q2W), for a series of 4 cycles.

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China