NCT06513364

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Beijing Wehand-Bio Pharmaceutical Co., Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, randomized, open-label, positive-drug parallel-controlled phase Ib trial. The primary aim of this study was to compare the safety, efficacy, and pharmacokinetics of a dose-dense regimen of bi-weekly WH002 followed by bi-weekly epirubicin and cyclophosphamide (ddWH002-ddEC) versus bi-weekly Paclitaxel® followed by bi-weekly EC (ddP-ddEC) as neoadjuvant treatment in women with HER2-negative high-risk early-stage and locally advanced breast cancer. Patients randomly assigned to ddP-ddEC received premedication with oral prednisolone (12 and 6 hours before paclitaxel), IV dexchlorpheniramine, and cimetidine or ranitidine (30 minutes before paclitaxel). Whereas all of these premedication was not required in the ddWH002-ddEC group before receiving WH002. Eligible subjects are those with biopsy-confirmed, HER2-negative breast cancer as verified by the research center, and whose tumor staging, as determined by imaging, falls into the categories of early high-risk (T1c-2, N1; T2, N0) or locally advanced (T1c-2, N2-3; T3-4, N0-3). Upon fulfilling all inclusion and exclusion criteria, participants will be randomized in a 1:1 ratio to either the WH002 followed by EC group (Group A) or the Paclitaxel® followed by EC group (Group B).Stratified randomization between the two groups based on tumor molecular subtypes: * Luminal type (HER2-negative, ER or progesterone receptor positive), * Triple-negative (HER2-negative, ER and progesterone receptor negative).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-08-15
• Completion: 2025-11-17
• First posted: 2024-07-22
• Last updated: 2026-01-20

Locations

1 site across 1 country: China