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

NCT00438100 | Completed Phase 2 Results DMC

• 2 other identifiers: JBCRN-05UMIN000000609
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 8

Brief 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

Keywords

Breast Neoplasms; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The follow up period will be two years after the last dose has been administered.

Secondary Outcomes (4)

• Adverse Events

  The follow up period will be two years after the last dose has been administered.

• Antitumor Effects

  The follow up period will be two years after the last dose has been administered.

• Time to Treatment Failure

  The follow up period will be two years after the last dose has been administered.

• Survival Rate

  The follow up period will be two years after the last dose has been administered.

Study Arms (2)

Capecitabine arm

ACTIVE COMPARATOR

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

Drug: Capecitabine

S-1 arm

EXPERIMENTAL

S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.

Drug: S-1

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Capecitabine arm

S-1 DRUG

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

Also known as: TS-1

S-1 arm

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: \<100,000/mm3 or more
• Hemoglobin: \>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: \< 25 mg/dL
• Creatinine: within a normal upper value in the institution
• hours creatinine clearance: \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Japan Breast Cancer Research Network: lead

Study Sites (8)

Seiko Hospital

Neyagawa, Osaka, 572-0831, Japan

Location

Kyushu Central Hospital

Fukuoka, 815-8588, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, 573-1191, Japan

Location

Hirosaki University Hospital

Hirosaki, 036-8563, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Shinyahashiradai Hospital

Matsudo, 270-2253, Japan

Location

The University of Tokyo Hospital

Tokyo, 113-8655, Japan

Location

Nagumo Clinic

Tokyo, 141-0032, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; S 1 (combination); titanium silicide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Tempei Miyaji
• Organization: The University of Tokyo

tmiyaji@m.u-tokyo.ac.jp

+81-3-5800-9086

Study Officials

• Daigo Yamamoto, MD

  Department of Surgery, Kansai Medical University Hirakata Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2007
• First Posted: February 21, 2007
• Study Start: April 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: May 1, 2013
• Last Updated: May 29, 2015
• Results First Posted: May 29, 2015

Record last verified: 2015-05

Locations

JP (8)