UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044444 |
|---|---|
| Receipt number | R000050773 |
| Scientific Title | Capecitabine/cyclophosphamide combination therapy for patients with metastatic breast cancer- a prospective cohort study |
| Date of disclosure of the study information | 2021/06/05 |
| Last modified on | 2021/06/05 15:24:59 |
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Basic information
Public title
Capecitabine/cyclophosphamide combination therapy for patients with metastatic breast cancer- a prospective cohort study
Acronym
KBC-SG0901
Scientific Title
Capecitabine/cyclophosphamide combination therapy for patients with metastatic breast cancer- a prospective cohort study
Scientific Title:Acronym
KBC-SG0901
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 feasibility and safety of capecitabine and cyclophosphamide combination therapy 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 time, overall survival, adverse event.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Performance status of 0, 1, or 2
4)Adequate bone marrow reserve, hepatic, renal functions, and normal cardiac function
5)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 | Kohjiro |
| Middle name | |
| Last name | Mashino |
Organization
Oita prefectural hospital
Division name
Department of breast surgery
Zip code
8708511
Address
2-8-1, Bunyo, Oita city, Oita
TEL
0975467111
mashinok@gmail.com
Public contact
Name of contact person
| 1st name | Kazuo |
| Middle name | |
| Last name | Tamura |
Organization
Kyushu Breast Cancer Study Group
Division name
Office
Zip code
8100004
Address
1-8-17-204, Watanabedori, Chuou-ku, Fukuoka city, Fukuoka
TEL
092-406-4166
Homepage URL
kbc@chotsg.com
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
Kyushu Breast Cancer Study Group
Address
1-8-17-204, Watanabedori, Chuou-ku, Fukuoka city, Fukuoka
Tel
0924064166
kbc@chotsg.com
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
| 2021 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
chotsg.com/kbc-sg/index.html
Publication of results
Partially published
Result
URL related to results and publications
chotsg.com/kbc-sg/index.html
Number of participants that the trial has enrolled
83
Results
83 cases registered, 2 cases excluded, 8 cases reference cases. There were 73 cases analyzed.
Results date posted
| 2021 | Year | 06 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
83 cases registered,
Participant flow
2 cases excluded, 8 cases reference cases. There were 73 cases analyzed.
Adverse events
There were no cases of study discontinuation due to adverse events.
Outcome measures
Response rate 28%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
83 cases are registered. 71 cases were analyzed.
Management information
Registered date
| 2021 | Year | 06 | Month | 05 | Day |
Last modified on
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050773
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
