UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
Acronym	ABROAD
Scientific Title	Randomized, optimal dose finding, Phase II Study of triweekly Abraxane in patients with metastatic breast cancer.
Scientific Title:Acronym	ABROAD
Region	Japan

Condition
Condition	metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate non-inferiority of low dose abraxane compared to current standard dose 260mg/m2 of abraxane in 1st or 2nd line chemotherapy for metastatic breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	progression-free survival(PFS)
Key secondary outcomes	time to treatment failure(TTF), overall survival (OS), response rate (RR), disease control rate (DCR), adverse events, PROs/HRQoL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Abraxane 260mg/m2 (SD arm) every 21 days, until disease progression
Interventions/Control_2	Abraxane 220mg/m2 (MD arm) every 21 days, until disease progression
Interventions/Control_3	Abraxane 180mg/m2 (LD arm) every 21 days, until disease progression
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	Male and Female
Key inclusion criteria	1) Histologically proven breast cancer. 2) One of the following conditions has to be met for a diagnosis of metastatic breast cancer. * At presentation, the patients have distant metastasis. * The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post-operative treatment); however, local recurrence is excluded. 3) The presence of at least one measurable lesion. However, sites treated by radiotherapy are not considered assessable lesions. 4) Performance status (ECOG scale): 0-1 5) Age of 20-75 years. 6) Adequate major organ functions within 14 days before enrollment., as defined below: Neutrophil count < 3,000/mm3 Platelet count < 100,000/mm3 Hemoglobin < 9.0 g/dL AST < 100 U/L ALT < 100 U/L Total bilirubin < 1.5 mg/dL Serum creatinine < 1.5 mg/dL 7) Written informed consent.
Key exclusion criteria	1) Overexpression of human epidermal growth factor receptor 2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive. 2) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less). 3) Grade2 or greater peripheral neuropathy 4) Severe allergic history against medicines 5) Severe complications, e.g., lung fibrosis, interstitial pneumonitis, uncotrolable diabetes meritus, severe cardiac dysfunction, renal failure, liver failure, cerebral vascular disorder, ulcer requiring blood transfusion. 6) Concurrent active infections. 7) The presence of brain metastasis requiring treatment 8) Psychiatric disorder affecting to get informed consent 9) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	138

Research contact person
Name of lead principal investigator	1st name Fumikata Middle name Last name Hara
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of breast oncology
Zip code	791-0280
Address	160 Kou, Minamiumemoto-chou, Matsuyama City, Ehime Prefecture 791-0280, Japan
TEL	089-999-1111
Email	hfumikat@shikoku-cc.go.jp

Public contact
Name of contact person	1st name Hiromi Middle name Last name Shinano
Organization	CSPOR-BC
Division name	Secretariat
Zip code	101-0021
Address	101 Gakkikaikan 2-18-21 Sotokanda Chiyoda, Tokyo, 101-0021
TEL	03-5294-7288
Homepage URL	http://cspor-bc.or.jp/study/index.html
Email	office-bc@cspor-bc.or.jp

Sponsor
Institute	CSPOR-BC
Institute
Department

Funding Source
Organization	TAIHO PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NHO Shikoku Cancer Center
Address	160 Ko Minamiumemoto Matsuyama Ehime JAPAN
Tel	089-999-1111
Email	hfumikat@shikoku-cc.go.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	四国がんセンター，国立がん研究センター東病院　など

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 01 Day

Related information
URL releasing protocol	http://cspor-bc.or.jp/study/index.html
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	2014 Year 09 Month 18 Day
Date of IRB	2014 Year 07 Month 24 Day
Anticipated trial start date	2015 Year 02 Month 16 Day
Last follow-up date	2019 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 10 Month 24 Day
Last modified on	2019 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916