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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Japan Breast Cancer Research Network.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Japan Breast Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00438100
First received: February 18, 2007
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: Capecitabine
Drug: S-1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Japan Breast Cancer Research Network:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: The follow up period will be two years after the last dose has been administered. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: The follow up period will be two years after the last dose has been administered. ] [ Designated as safety issue: Yes ]
  • Antitumor effects [ Time Frame: The follow up period will be two years after the last dose has been administered. ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: The follow up period will be two years after the last dose has been administered. ] [ Designated as safety issue: Yes ]
  • Survival rate [ Time Frame: The follow up period will be two years after the last dose has been administered. ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
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
1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Other Name: Xeloda
Experimental: B
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
80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.

Detailed Description:

The incidence of breast cancer is increasing in Japan: 33,676 women were diagnosed with breast cancer in 2001, making it the leading cause of cancer among women since 1995. Statistical database in Exel format/outline of health welfare statistics from the Ministry of Labor, Health, and Welfare show that the number of deaths from breast cancer was 9,806 in 2003. Because the ten-year survival rate is about ninety percent in Stages 0 and I breast cancer patients, detection and treatment at an earlier stage can lead to higher survival rates. However, the recurrence rate increases as the disease progresses. In addition, about thirty percent of all breast cancer patients are believed to have recurrent disease. Thus, developing treatments against recurrence may be an important task.

The Guideline for Breast Cancer Treatment, 2004 version, recommends chemotherapy, including anthracyclines or taxanes as a first-line chemotherapy for metastatic or recurrent (grade B recommendation) breast cancer. In a second-line therapy recommended for metastatic or recurrent diseases, the Guideline reports that a combination of capecitabine, a 5Fu derivative (an oral chemotherapy of pyrimidine fluorides approved in 2003) with docetaxel is superior to docetaxel alone for improving survival. This regimen is recommended for patients with cardiac malfunction who cannot be treated with anthracyclines (grade B recommendation). However, data are lacking to support capecitabine as a standard regimen as a second-line therapy; its efficacy needs verification and further study. Accordingly, this study is designed to investigate the efficacy and safety of S-1 alone, an oral pyrimidine fluoride, to which an indication of "inoperable or recurrent breast cancer" was added, as a first-line therapy in patients with inoperable or recurrent breast cancer by comparing it with Capecitabine alone, which is already approved of the same indication.

  Eligibility

Ages Eligible for Study:   25 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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: <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
    • 24 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438100

Locations
Japan
Seiko Hospital
Neyagawa, Osaka, Japan, 572-0831
Kyushu Central Hospital
Fukuoka, Japan, 815-8588
Kansai Medical University Hirakata Hospital
Hirakata, Japan, 573-1191
Hirosaki University Hospital
Hirosaki, Japan, 036-8563
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Shinyahashiradai Hospital
Matsudo, Japan, 270-2253
The University of Tokyo Hospital
Tokyo, Japan, 113-8655
Nagumo Clinic
Tokyo, Japan, 141-0032
Sponsors and Collaborators
Japan Breast Cancer Research Network
Investigators
Principal Investigator: Daigo Yamamoto, MD Department of Surgery, Kansai Medical University Hirakata Hospital
  More Information

No publications provided

Responsible Party: Japan Breast Cancer Research Network
ClinicalTrials.gov Identifier: NCT00438100     History of Changes
Other Study ID Numbers: JBCRN-05, UMIN000000609
Study First Received: February 18, 2007
Last Updated: December 5, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Japan Breast Cancer Research Network:
Breast Neoplasms
Drug Therapy

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014