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Irinotecan/Capecitabine Versus Capecitabine in Patients Treated With A/T for HER2 Negative Metastatic Breast Cancer

NCT01501669 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2012-07-18

No results posted yet for this study

Summary

This study is a multicenter, randomized study, open-label, phase III study.The efficacy of irinotecan and capecitabine combination will be superior to capecitabine alone in term of progression free survival in metastatic breast cancer patients previously treated with anthracycline and taxane.

Conditions

Interventions

DRUG

Irinotecan, Capecitabine

Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks \+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Chung-Ang University

    collaborator OTHER

  • Inha University Hospital

    collaborator OTHER

  • Korea University Anam Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jungsil Ro · National Cencer Center, Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • South Korea

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 NCT01501669 on ClinicalTrials.gov