Clinical trial NCT00438100: Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
Official title: Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast Neoplasms
Drug Therapy
Lead sponsor: Japan Breast Cancer Research Network
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 142
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: The follow up period will be two years after the last dose has been administered.
Secondary outcomes:
measure: Adverse Events
timeFrame: The follow up period will be two years after the last dose has been administered.
measure: Antitumor Effects
timeFrame: The follow up period will be two years after the last dose has been administered.
measure: Time to Treatment Failure
timeFrame: The follow up period will be two years after the last dose has been administered.
measure: Survival Rate
timeFrame: The follow up period will be two years after the last dose has been administered.
Other outcomes:
Locations:
city: Neyagawa
country: Japan
facility: Seiko Hospital
state: Osaka
city: Fukuoka
country: Japan
facility: Kyushu Central Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hirakata Hospital
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Matsudo
country: Japan
facility: Shinyahashiradai Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo Hospital
city: Tokyo
country: Japan
facility: Nagumo Clinic
Study officials:
affiliation: Department of Surgery, Kansai Medical University Hirakata Hospital
name: Daigo Yamamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: