UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016213 |
|---|---|
| Receipt number | R000018742 |
| Scientific Title | A feasibility study of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting |
| Date of disclosure of the study information | 2015/01/28 |
| Last modified on | 2017/12/19 09:47:40 |
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Basic information
Public title
A feasibility study of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting
Acronym
A feasibility study of dose-dense chmotherapy for primary breast cancer
Scientific Title
A feasibility study of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting
Scientific Title:Acronym
A feasibility study of dose-dense chmotherapy for primary breast cancer
Region
| Japan |
Condition
Condition
Primary breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility of dose-dense epirubicin and cyclophosphamide for primary breast cancer in neoadjuvant and adjuvant setting
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relative dose intensity
Key secondary outcomes
Adverse events
To evaluate the accumulation of pegfirugrasutim
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A chemotherapy treatment plan in which drugs are given with less time between treatments than in a standard chemotherapy treatment plan.
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with primary breast cancer who had been decided to treat epirubicin and cyclophosphamide in neoadjuvant or adjuvant setting.
Additional eligibility criteria for enrollement include: having no evidence of metastatic disease, having the following laboratory values: absolute neutrophil count >=1500/mm3, hemoglobin >=9.0g/dl, platelets >=100,000/mm3, aspartate aminotransferase and alanine aminotransferase <=100IU/ml, serum bilirubin <=1.5mg/dl, serum creatinine <=1.5mg/dl, being no cardiac dysfunction on ECG and US, having an Eastern Cooperative Oncoligy Group performance status of O or 1, and having been written informed consent.
Key exclusion criteria
Patients with active infection need to treat systemic therapy, nursing, mental disorder, or other uncontrolled medical conditions are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560 Japan
TEL
052-744-1903
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachi Morita |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8560 Japan
TEL
052-744-1903
Homepage URL
s-kamei@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-017-1177-z
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
Main results already published
Date of protocol fixation
| 2014 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2017 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
