UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004696 |
|---|---|
| Receipt number | R000005589 |
| Scientific Title | Patient preferences for oral versus intravenous adjuvant chemotherapy for early breast cancer |
| Date of disclosure of the study information | 2010/12/10 |
| Last modified on | 2013/12/11 09:09:35 |
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Basic information
Public title
Patient preferences for oral versus intravenous adjuvant chemotherapy for early breast cancer
Acronym
Patient preferences for chemotherapy for early breast cancer
Scientific Title
Patient preferences for oral versus intravenous adjuvant chemotherapy for early breast cancer
Scientific Title:Acronym
Patient preferences for chemotherapy for early breast cancer
Region
| Japan |
Condition
Condition
Early breast cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess patient preference for oral versus intravenous adjuvant chemotherapy for early breast cancer, we use questionnaires about their preferences for routes of administration of
chemotherapy.
Basic objectives2
Others
Basic objectives -Others
questionnaires
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient preferences for oral versus intravenous adjuvant chemotherapy for early breast cancer are assessed by questionnaires and evaluated the relationship of preference with various factors.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Postmenopausal women with stage I to III breast cancer at diagnosis
2) HER2 negative
3) ER and/or PgR positive
4) Already finished her adjuvant chemotherapy
5) No evidences of diseases at trial entry
Key exclusion criteria
1) had a history of other active invasive malignancy in the past 5 years
2) Any reason the physician believes that the patient is not appropriate to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ishitobi |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyo Shibuya |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
TEL
06-6972-1181
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
height, weight, marital status, income, level of completed education, employment status, age at menarche and menopause, prior pregnancy or childbearing, hormone replacement use, the date of birth, clinicopatologic factors of breast cancer
Management information
Registered date
| 2010 | Year | 12 | Month | 09 | Day |
Last modified on
| 2013 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005589
