MedTrace Logo

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

NCT06513364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-20

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Beijing Wehand-Bio Pharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Fei Ma, MD · National Cancer Center/Cancer Hospital, Peking Union Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2025-08-15
Completion
2025-11-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513364 on ClinicalTrials.gov