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Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC)

NCT01287624 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2015-03-23

No results posted yet for this study

Summary

This is a prospective, multi-center, open-labeled, randomized phase III clinical trial comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS) and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine paclitaxel combination (GT).

Conditions

Interventions

DRUG

Gemcitabine,cisplatin

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1

DRUG

Gemcitabine, Paclitaxel

Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1

Sponsors & Collaborators

  • 307 Hospital of PLA

    collaborator OTHER

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Fudan University

    lead OTHER

Principal Investigators

  • Xichun Hu, MD,PhD · Fudan University

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
2011-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

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 NCT01287624 on ClinicalTrials.gov