Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer

NCT00438100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2015-05-29

Study results available
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Summary

To investigate and compare the efficacy and safety of S-1 vs. Capecitabine as primary chemotherapy in patients with inoperable or recurrent breast cancer.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Capecitabine

1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.

DRUG

S-1

80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.

Sponsors & Collaborators

  • Japan Breast Cancer Research Network

    lead OTHER

Principal Investigators

  • Daigo Yamamoto, MD · Department of Surgery, Kansai Medical University Hirakata Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2012-07-31
Completion
2013-05-31

Countries

  • Japan

Study Locations

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Entities

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 NCT00438100 on ClinicalTrials.gov