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Efficacy and Safety Study of Trastuzumab and Paclitaxel Based Regimens to Treat HER2-positive Breast Cancer

NCT01428414 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-08-23

No results posted yet for this study

Summary

The purpose of the investigators study is to compare the efficacy and safety of combining trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant treatment. The main end point of this study would be the efficacy and safety of the two treatment arms, and the trend of the two curves is anticipated.

Conditions

  • HER-2 Positive Breast Cancer

Interventions

DRUG

Trastuzumab

2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw

DRUG

Paclitaxel

75mg/m2, iv d1, 8,15. qw; 4-6 cycles

DRUG

Epirubicin

75mg/m2, iv d1, q3w, 4-6 cycles

DRUG

Carboplatin

AUC 2, qw, iv d1, 8,15. 4-6 cycles

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Zhimin Shao

    lead OTHER

Principal Investigators

  • Zhi-Ming Shao, MD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-08-31
Completion
2015-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT01428414 on ClinicalTrials.gov