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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044444
Receipt No. 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

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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
Email 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
Email kbc@chotsg.com

Sponsor
Institute Kyushu Breast Cancer Study Group
Institute
Department

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
Email 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
URL(English) https://upload.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


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