UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026954
Receipt No. 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 2018/04/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kanako Saito
Organization Mie University Hospital
Division name Department of Oncology
Zip code
Address 2-174, Edobashi, Tsu, Mie
TEL 059-231-1111
Email kana-s@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Oda
Organization Mie University Hospital
Division name Department of Oncology
Zip code
Address 2-174, Edobashi, Tsu, Mie, Japan
TEL 059-231-1111
Homepage URL
Email kasbecvdoelfhg@yahoo.co.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Donation for research
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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 04 Month 17 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
2017 Year 04 Month 11 Day
Last modified on
2018 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030913

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.