MedTrace Logo

A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab

NCT03264547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2025-09-29

No results posted yet for this study

Summary

To verify that combination therapy with trastuzumab + pertuzumab + eribulin brings similar PFS and better QOL compared to trastuzumab + pertuzumab + taxane in advanced/recurrent HER2-positive breast cancer patients who have no medical history of chemotherapy except ado-trastuzumab emtansine

Conditions

Interventions

DRUG

Pertuzumab

Every 3 weeks

DRUG

Trastuzumab

Every 3 weeks

DRUG

Docetaxel

Every 3 weeks

DRUG

Paclitaxel

Every week

DRUG

Eribulin

Administered for 2 weeks and is then stopped to be administered for 1 week

Sponsors & Collaborators

  • Eisai Co., Ltd.

    collaborator INDUSTRY

  • Japan Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Toshinari Tamashita, MD, PhD · Kanagawa Cancer Center

  • Norikazu Masuda, MD, PhD · NHO Osaka National Hospital

  • Shigehira Saji, MD, PhD · Fukushima Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT03264547 on ClinicalTrials.gov