Phase 2 N=142 Randomized Treatment

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

Breast Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00438100 ↗

Enrolled (actual)

142

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Progression Free Survival — 1.2; 1.3 years

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Capecitabine (Drug); S-1 (Drug)
Age: Adult, Older Adult · 25+ yrs
Sex: Female
Sponsor: Japan Breast Cancer Research Network
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival	1.2; 1.3	—
SECONDARY Adverse Events	—	—
SECONDARY Antitumor Effects	—	—
SECONDARY Time to Treatment Failure	—	—
SECONDARY Survival Rate	—	—

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.

Eligibility Criteria

Inclusion Criteria

Biopsy-diagnosed breast cancer with metastasis in multiple organs
Performance Status (World Health Organization : WHO) 0-2
Functions below are maintained in major organs:
Leukocyte count: 4,000/mm3 to 12,000/mm3
Neutrophil count: >2,000/mm3 or more
Platelet count: 9.5 g/dL
Total bilirubin: >1.5 mg/dL
AST(GOT): within twice a normal upper value in an institution
AST(GPT): within twice a normal upper value in an institution
BUN: 50 mL/min (using the Cockcroft-Gault formula)
Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
Written informed consent will be obtained for patients for entering this study

Exclusion Criteria

Patients with synchronous multiple cancers
Complicated with infection
Fever from suspected infection
Metastasis to the central nerve system
A history of ischemic cardiac diseases
Active gastrointestinal ulcer
Severe nerve disorder
Women who are potentially pregnant, pregnant, or breast-feeding
Severe drug allergy
Severe suppression of the bone marrow
Severe renal disorder
Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
Being treated with flucytosine
Complicated with the infection onset which a study doctor assesses to be inappropriate for this study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00438100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.