UMIN-CTR Clinical Trial

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
Email	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
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	Hyogo Cancer Center
Address	13-70, Kitaoji-cho, Akashi,Hyogo,Japan
Tel	078-929-1151
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028756