UMIN-CTR Clinical Trial

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
Email	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
Email	h-oda@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030913