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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024992
Receipt No. R000028756
Scientific Title Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Date of disclosure of the study information 2016/11/25
Last modified on 2018/02/05

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Basic information
Public title Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Acronym Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Scientific Title Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Scientific Title:Acronym Phase 2 study of dose dense AC and dose dense PTX as perioperative chemotherapy for patients with HER2 negative breast cancer(WJOG9016B)
Region
Japan

Condition
Condition HER2 negative breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the ddAC followed by ddPTX for patients with HER2 negative breast cancer in stage I - III
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The proportion of high RDI, defined as the proportion of patients whose RDI of the therapy exceeds 85 % among those who started treatment
Key secondary outcomes 1) Mean and median RDI of the whole therapy
2) Mean, median and the proportion of high RDI of ddAC
3) Mean, median and the proportion of high RDI of ddPTX
4) The proportion of patients without delay & dose reduction
5) Safety (including SAE)
6) ORR, BCR, pCR, and recurrence of the neoadjuvant treatment
7) Recurrence rate of the adjuvant treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ddAC day1 Doxorubicine 60mg/m2, and Cyclophosphamide 600 mg/m2
day 2, 3, or 4 pegfilgrastim 3.6mg
every two weeks, repeat four times

ddPTX day1 paclitaxel 175mg/m2, day 2, 3, or 4 pegfilgrastim 3.6mg
every two weeks, repeat four times
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Invasive ductal carcinoma
2) HER2 negative
3) Stage I-III
4) ECOG PS 0 or 1
Key exclusion criteria 1) Active double cancer
2) Active infection
3) Lactating, pregnant, or not willing to contraception women
4) Mental disorders
5) On steroids or immune suppressants
6) History of severe hypersensitivity
7) History of severe complication
8) Judged as inappropriate to be included study by treating physician
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Matsumoto
Organization Hyogo Cancer Center
Division name Medical Oncology
Zip code
Address 13-70, Kitaoji-cho, Akashi,Hyogo,Japan
TEL 078-929-1151
Email kojmatsu@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Nakamura
Organization West Japan Oncology Group
Division name WJOG datacenter
Zip code
Address Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL 06-6633-7400
Homepage URL
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 25 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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 10 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
2016 Year 11 Month 25 Day
Last modified on
2018 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028756

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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