UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026954 |
|---|---|
| Receipt number | R000030913 |
| Scientific Title | Feasibility study of dose dense chemotherapy for primary breast cancer patients |
| Date of disclosure of the study information | 2017/04/17 |
| Last modified on | 2020/04/16 08:56:37 |
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Basic information
Public title
Feasibility study of dose dense chemotherapy for primary breast cancer patients
Acronym
Feasibility study of dose dense chemotherapy for primary breast cancer patients
Scientific Title
Feasibility study of dose dense chemotherapy for primary breast cancer patients
Scientific Title:Acronym
Feasibility study of dose dense chemotherapy for primary breast cancer patients
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
To evaluate the feasibility of dose dense chemotherapy in Japanese breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate of treatment, safety
Key secondary outcomes
Disease free survival, overall survival, dose intensity, exploratory study to determine predictive factors of efficacy of dose dense chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anthracycline followed by taxane
Anthracyclin (1 or 2)
1) dose dense AC (ddAC);
Day1 Doxorubicin 60 mg/m2, Cyclophosphamide 600 mg/m2
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles
2) dose dense EC (ddEC);
Day1 Epirubicin 90 mg/m2, Cyclophosphamide 600 mg/m2, day 1
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles
Taxane (3 or 4)
3) weekly Paclitaxel:
Day1 Paclitaxel 80 mg/m2
weekly, 12 cycles
4) dd-PTX:
Day1 PTX 175 mg/m2
Day3 Pegfilgrastim 3.6 mg
every 2 weeks, 4 cycles
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
1. Invasive ductal carcinoma
2. Stage I-III
3. Age >=20 and 75=<
4. ECOG PS 0 or 1
5. Vital organ functions are preserved
6. Written IC
Key exclusion criteria
1. Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
2. History of drug-related allergy which could hinder planned treatment
3. Any history or complication of following cardiac disorders
- History of congestive heart failure, cardiac infarction
- Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
4. Poorly controlled hypertension
5. Poorly controlled diabetes
6. Pregnancy
7. Ineligible to the trial based on decision of an investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Saito |
Organization
Mie University Hospital
Division name
Department of Oncology
Zip code
5148507
Address
2-174, Edobashi, Tsu, Mie
TEL
059-232-1111
kana-s@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Oda |
Organization
Mie University Hospital
Division name
Department of Oncology
Zip code
5148507
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
059-232-1111
Homepage URL
h-oda@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Donation for research from hospitals
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital Clinical Research Review Board
Address
2-174, Edobashi, Tsu, Mie, Japan
Tel
059-231-5045
s-kenkyu@mo.medic.mie-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
三重大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 11 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030913
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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