Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00438100|
Recruitment Status : Completed
First Posted : February 21, 2007
Results First Posted : May 29, 2015
Last Update Posted : May 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Capecitabine Drug: S-1||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Control Study of Capecitabine vs. S-1 in Unresectable or Recurrent Breast Cancer Patients|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||May 2013|
Active Comparator: Capecitabine arm
Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
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: S-1 arm
S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
Other Name: TS-1
- Progression Free Survival [ Time Frame: The follow up period will be two years after the last dose has been administered. ]
- Adverse Events [ Time Frame: The follow up period will be two years after the last dose has been administered. ]
- Antitumor Effects [ Time Frame: The follow up period will be two years after the last dose has been administered. ]
- Time to Treatment Failure [ Time Frame: The follow up period will be two years after the last dose has been administered. ]
- Survival Rate [ Time Frame: The follow up period will be two years after the last dose has been administered. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438100
|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|
|Matsudo, Japan, 270-2253|
|The University of Tokyo Hospital|
|Tokyo, Japan, 113-8655|
|Tokyo, Japan, 141-0032|
|Principal Investigator:||Daigo Yamamoto, MD||Department of Surgery, Kansai Medical University Hirakata Hospital|