UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Acronym	KOEB2 trial
Scientific Title	Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Scientific Title:Acronym	KOEB2 trial
Region	Japan

Condition
Condition	Eligible patients were those with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1, followed by HER + PER + eribulin.
Classification by specialty	Hematology and clinical oncology Surgery in general Breast surgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy and safety of HER + PER + eribulin for patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall response rate: ORR
Key secondary outcomes	progression-free survival: PFS overall survival: OS adverse events

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 female patients with diagnosis of breast cancer by histological or cytological examination. 2 ECOG performance status (PS) 0-2 3 with measurable disease lesion by RECIST 4 patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1 (other additional chemotherapy and endocrine therapy is allowed) 5 without previous eribulin treatment 6 with normal organ function fulfill the criteria below of laboratory data in 7 days before register 6-1. neutrophils: more than 1,500/mm3 6-2. platelets: more than 100,000mm3 6-3. Hb: more than 9.0g/dL 6-4. total bilirubin: less than 2.0 mg/dL 6-5. AST (GOT), ALT (GPT), ALP: less than 2.5 ULN 6-6. serum creatinine: less than 1.5 mg/dL 7 prognosis of more than 3 months is expected 8 no clinical problem with ECG 9 who agreed to register in this trial with written consent
Key exclusion criteria	1 infection 2 severe allergy for medication 3 severe heart, renal, liver dysfunction 4 interstitial pneumonia or pulmonary fibrosis 5 large amount of pleural effusion or ascites 6 hypertension or diabetes that is poorly controlled 7 under steroid therapy 8 pregnant woman 9 who received transfusion, blood products, and hematopoietic factor products within 7 days 10 active double cancer (simultaneous double cancer and metachronous cancer within 5 years except for carcinoma in situ and intramucosal cancer) 11 history of psychiatric or CNS disorders which casts clinical problems 12 diagnosis or suspect of brain metastasis 13 engaging in other clinical trials 14 when responsible doctors made a judgement of inappropriate patient
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Tetsu Middle name Last name Hayashida
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	161-8582
Address	35 Shinanomachi Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Email	tetsu@keio.jp

Public contact
Name of contact person	1st name Takamichi Middle name Last name Yokoe
Organization	Keio University School of Medicine
Division name	Department of Surgery
Zip code	160-8582
Address	35 Shinanomachi Shinjuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	takamichi.yokoe@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Keio University School of Medicine
Address	35 Shinanomachi Shinjuku, Tokyo, Japan
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.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	2018 Year 11 Month 01 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	Preinitiation
Date of protocol fixation	2018 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2025 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Registration period: 2 years Follow-up period: 5 years

Management information
Registered date	2018 Year 10 Month 13 Day
Last modified on	2020 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037970