Unique ID issued by UMIN | C000000022 |
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Receipt number | R000000030 |
Scientific Title | Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study |
Date of disclosure of the study information | 2005/07/07 |
Last modified on | 2011/07/26 11:25:05 |
Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
XC phase 2 study for MBC
Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
XC phase 2 study for MBC
Japan |
Breast cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
The purpose of this study is to evaluate the feasiblity and safety of capecitabine-cyclophospamide combination for metastatic breast cancer
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Response rate
Progression-free survival(PFS), overall survival(OS), adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
chemotherapy
capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles
20 | years-old | <= |
74 | years-old | >= |
Female
1)Inoperable advanced or recurrent breast cancer
2)Negative HER2 status (0 or 1+ by immunohistochemistry or negative by FISH)
3)Required to have received previous systemic chemotherapy containing the anthracycline
4)No previous systemic chemotherapy with taxanes or oral doxifludine/cyclophosphamide combination.
Permitted to enter this trial, only if more than one year passed after the completion of preoperative or
postoperative settings using these drugs.
5)Performance status of 0, 1, or 2
6)Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function
7)Written informed consent is required to obtain from each patient at each participating institution
1)Pregnant or breast feeding
2)Documented history of serious hypersensitivity reaction on the medical drugs
3)Patients who have experienced prior chemotherapy with capecitabine
4)With metastasis to the central nervous system
5)Serious underlying medical illness with heart, gastrointestinal tract, or infection
70
1st name | |
Middle name | |
Last name | Shousyu Mitsuyama |
Kitakyusyu Municipal Medical Center
Surgery
1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyusyu Japan
093-541-1831
1st name | |
Middle name | |
Last name |
Kyushu Breast Cancer Study Group
Executive Office
45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka Japan
092-801-1011
ktamura@fukuoka-u.ac.jp
Kyushu Breast Cancer Study Group
Non profit organization Clinical Hematology/Oncology Study Group
Non profit foundation
NO
2005 | Year | 07 | Month | 07 | Day |
Published
Completed
2005 | Year | 05 | Month | 26 | Day |
2005 | Year | 07 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2005 | Year | 07 | Month | 07 | Day |
2011 | Year | 07 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000030
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