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A Comparison of Nab-PHP and TCbHP Efficacy in Neoadjuvant Therapy for HER2-positive Early Breast Cancer

NCT04547907 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2024-09-20

No results posted yet for this study

Summary

The aim of this study is to evaluates the efficacy of weekly nab-paclitaxel monotherapy compared to the standard regimen of docetaxel plus carboplatin, both supplemented with trastuzumab and pertuzumab, as neoadjuvant therapies for HER2-positive breast cancer.

Conditions

  • Breast Cancer,HER2-positive

Interventions

DRUG

Nab-paclitaxel+ trastuzumab+ patuzumab

Nab-paclitaxel 125mg/m2 (days 1, 8, 15) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

DRUG

Docetaxel+ carboplatin+ trastuzumab + patuzumab

Docetaxel 75 mg/m2(day 1) + Carboplatin (AUC=6) (day 1) + Trastuzumab (initial loading dose of 8 mg/kg, subsequent maintenance dose of 6 mg/kg) + Pertuzumab (initial loading dose of 840mg, subsequent maintenance dose of 420mg), every 21 days constitute a cycle.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Zhenzhen Liu · Study Principal Investigator Henan Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-18
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT04547907 on ClinicalTrials.gov