UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of first line chemotherapy by eribulin mesilate for HER2 negative recurrent breast cancer
Acronym	KBCOG 11
Scientific Title	A phase II study of first line chemotherapy by eribulin mesilate for HER2 negative recurrent breast cancer
Scientific Title:Acronym	KBCOG 11
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 efficacy and safety of elibulin mesylate for HER2 negative breast cancer not to be treated by chemotherapy after recurrence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	objective response rate
Key secondary outcomes	progression free survival, over all survival, safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	eliblin mesylate 1.4mg/m2, day1,8, div Treatment is administered every 3 weeks until evidence of disease progression, unacceptable toxicity, patient refusal.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1)histlogically or cytologically confirmed breast cancer 2)HER2 negative recurrent breast cancer patients 3)with interval period of 4 weeks after post operative adjuvant chemotherapy, 2 weeks after endocrine therapy or radiation 4) with previous treatment by anthracyclin and taxan for perioperative chemotherapy and without chemotherapy after recurrence 5) with evaluable lesion by RECIST criteria 6) ECOG perfomance status 0-2 7) required baseline laboratory parameters (within 2 weeks before registration) WBC >3,000/mm3 neutrophil >1,500/mm3 Plt >10,000/mm3 Hb >9.0g/dL AST <2.5 times ULN and ALT <2.5 times ULN (<5.0 with liver metastasis) serum creatinine <1.5 time ULN 8) with life expectancy greater than 3 months 9) written informed consent was obtained
Key exclusion criteria	1) serious complication or past history: with symptomatic heart failure, liver cirrhosis, psychological disorder treated by antipsychotic drug, ischemic heart disease within 6 months, etc 2) active infection 3) peripheral neuropathy greater than Grade 3 4) male breast cancer 5) pregnant or nursing women, women who like be pregnant 6) with doctors decision for exclusion
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Shigeoka
Organization	Yodogawa Christian Hospital
Division name	Medical Oncology
Zip code	533-0024
Address	1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
TEL	09072071221
Email	a109137@ych.or.jp

Public contact
Name of contact person	1st name Yasushi Middle name Last name Shigeoka
Organization	Yodogawa Christian Hospital
Division name	Medical Oncology
Zip code	533-0024
Address	1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
TEL	09072071221
Homepage URL
Email	y45shigeok@gmail.com

Sponsor
Institute	Kobe Breast Cancer Oncology Group
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

IRB Contact (For public release)
Organization	Yodogawa Christian Hospital
Address	1-7-50 Kunijima, Higashi Yodogawa-ku, Osaka
Tel	09072071221
Email	a109137@ych.or.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	淀川キリスト教病院(大阪府)、兵庫県立がんセンター(兵庫県)、神戸大学医学部附属病院(兵庫県)、兵庫医科大学病院(兵庫県)、甲南病院(兵庫県)、県立西宮病院(兵庫県)、明和病院(兵庫県)、姫路赤十字病院(兵庫県)、大山病院(兵庫県)、尼崎総合医療センター(兵庫県)、赤穂市民病院(兵庫県)、済生会兵庫県病院(兵庫県)、神鋼記念病院(兵庫県)、製鉄記念広畑病院(兵庫県)、加古川医療センター(兵庫県)、西神戸医療センター(兵庫県)、神戸医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2012 Year 04 Month 24 Day
Date of IRB	2012 Year 04 Month 30 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 07 Month 31 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 05 Month 19 Day
Last modified on	2022 Year 11 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009395