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Sponsored by: |
Japan Breast Cancer Research Network |
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Information provided by: | Japan Breast Cancer Research Network |
ClinicalTrials.gov Identifier: | NCT00438100 |
To investigate and compare the efficacy and safety of TS-1 vs. Xeloda as primary chemotherapy in patients with inoperable or recurrent breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms |
Drug: Capecitabine Drug: TS-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Control Study of Xeloda Alone vs. TS-1 Alone as First-Line Treatment in Unresectable or Recurrent Breast Cancer Patients |
Estimated Enrollment: | 220 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2024 |
Estimated Primary Completion Date: | May 2022 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: 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.
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Drug: Capecitabine
1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
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B: Experimental
TS-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.
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Drug: TS-1
80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
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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 TS-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 Xeloda (capecitabine) alone, which is already approved of the same indication.
Ages Eligible for Study: | 25 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Functions below are maintained in major organs:
Exclusion Criteria:
Contact: Satoru Iwase, MD | 81-3-3815-5411 ext 37417 | iwases-rad@umin.ac.jp |
Japan | |
Kansai Medical University Hirakata Hospital | Recruiting |
Hirakata, Japan, 573-1191 | |
Hirosaki University Hospital | Recruiting |
Hirosaki, Japan, 036-8563 | |
The University of Tokyo Hospital | Suspended |
Tokyo, Japan, 113-8655 | |
Kyushu Central Hospital | Recruiting |
Fukuoka, Japan, 815-8588 | |
Shinyahashiradai Hospital | Suspended |
Matsudo, Japan, 270-2253 | |
Hiroshima University Hospital | Suspended |
Hiroshima, Japan, 734-8551 | |
Nagumo Clinic | Recruiting |
Tokyo, Japan, 141-0032 |
Principal Investigator: | Daigo Yamamoto, MD | Department of Surgery, Kansai Medical University Hirakata Hospital |
Responsible Party: | Japan Breast Cancer Research Network ( Japan Breast Cancer Research Network ) |
Study ID Numbers: | JBCRN-05, UMIN000000609 |
Study First Received: | February 18, 2007 |
Last Updated: | August 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00438100 |
Health Authority: | Japan: Institutional Review Board |
Breast Neoplasms Drug Therapy |
Capecitabine Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |