UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000022 |
|---|---|
| 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 | 2025/12/23 15:12:21 |
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Basic information
Public title
Capecitabine/cyclophosphamide combination therapy for patients with advanced or metastatic breast cancer who have been previously treated with anthracyclines - a phase 2 study
Acronym
XC phase 2 study for MBC
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
Scientific Title:Acronym
XC phase 2 study for MBC
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasiblity and safety of capecitabine-cyclophospamide combination for metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival(PFS), overall survival(OS), adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy
capecitabine 1657mg/m2, cyclophosphamide 65mg/m2, q3w, 6cycles
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shousyu |
| Middle name | |
| Last name | Mitsuyama |
Organization
Kitakyusyu Municipal Medical Center
Division name
Surgery
Zip code
802-0077
Address
1-1, 2-chome, Bashaku, Kokurakita-ku, Kitakyusyu Japan
TEL
093-541-1831
shomi@crest.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Tamura |
Organization
Kyushu Breast Cancer Study Group
Division name
Executive Office
Zip code
814-0180
Address
45-1, 7-chome, Nanakuma, Jonan-ku, Fukuoka Japan
TEL
092-801-1011
Homepage URL
http://www.chotsg.com/kbc-sg/index.html
ktamura@fukuoka-u.ac.jp
Sponsor or person
Institute
Kyushu Breast Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Non profit organization Clinical Hematology/Oncology Study Group
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Hospital Clinical Research Assist Center
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
Tel
092-801-1011
kenji0715@adm.fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
http://www.chotsg.com/
Publication of results
Published
Result
URL related to results and publications
Anti-Cancer Drugs 21(4):p 453-458, April 2010|
Number of participants that the trial has enrolled
48
Results
48 MBC patients (median age 58) enrolled; 3 withdrew pre-treatment. Of 45 evaluable, CR2 and PR14 gave ORR 35.6%. Median PFS 199 days, OS 677 days. Grade 3 neutropenia/leukopenia 11%, anemia/thrombocytopenia 2%. Nonhematologic toxicities mild; hand-foot syndrome in 14, no grade 3-4. Oral XC showed efficacy with good tolerability.
Results date posted
| 2025 | Year | 12 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
HER2-negative MBC who were earlier treated with anthracyclines
Participant flow
Patients with HER2-negative metastatic breast cancer (MBC) who have a history of treatment with anthracyclines and have provided informed consent to participate in this study will be registered with the study office (Nonprofit Organization for Clinical Hematology and Oncology Research Group). After registration, treatment will be initiated and continued until disease progression (PD), death, or discontinuation of treatment based on the patients request or the judgment of the attending physician or treatment toxicity..
Adverse events
Grade 3 neutropenia and leukopenia developed in 11%, and that of anemia and thrombocytopenia in 2% patients. Nonhematological toxicities were mild. Hand--foot syndrome was observed in 14 patients but no one had grade 3-4 toxicity.
Outcome measures
A complete response was obtained in two of the 45 evaluable patients, and partial response in 14, resulting in an overall response rate of 35.6%. The median progression-free survival and overall survival were 199 (115-231) days and 677 (437 approximately ) days, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 07 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000030
