UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024992 |
|---|---|
| Receipt number | 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 | 2022/05/31 10:40:27 |
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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 | Koji |
| Middle name | |
| Last name | Matsumoto |
Organization
Hyogo Cancer Center
Division name
Medical Oncology
Zip code
673-8558
Address
13-70, Kitaoji-cho, Akashi,Hyogo,Japan
TEL
078-929-1151
kojmatsu@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
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
Hyogo Cancer Center
Address
13-70, Kitaoji-cho, Akashi,Hyogo,Japan
Tel
078-929-1151
rinsyosikenkanri@hyogo-cc.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
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 16 | Day |
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
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028756
